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Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

July 20, 2005
05-29

______________________________
PRODUCT
Baked Lays Original flavor potato crisps, 1 1/8 oz. packages, Recall # F-479-5
CODE
Expiration Date: AUG 9, Lot Code: 215313005 Time Stamp: 23:27 through 02:29
RECALLING FIRM/MANUFACTURER
Frito Lay, Inc., Plano, TX, by press release and letter on June 7, 2005. Firm initiated recall is ongoing.
REASON
Bags labeled as “Original” potato crisps actually contained Sour Cream & Onion potato crisps. The Sour Cream & Onion flavor contain milk-derived ingredients that are not listed on the label of the Original flavor bag.
VOLUME OF PRODUCT IN COMMERCE
265 cases
DISTRIBUTION
PA, OH, MD, WV, MI, WI, MN, IL, IA, MA, CN, IN

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PRODUCT
a) CaBoom! Bayou-Q Spicy BBQ Sauce packaged in 16 ounce
bottles and 1 gallon plastic jugs. Recall # F-480-5;
b) CaBoom! Bayou-Q Hot BBQ Sauce packaged in 16 oz.
bottles and 1 gallon plastic jugs. Recall # F-481-5;
c) CaBoom! Bayou-Q XHot BBQ Sauce packaged in 16 oz.
bottles and 1 gallon plastic jugs. Recall # F-482-5;
d) Gecko Gary’s Brushfire Spicy BBQ sauce packaged in 16
oz. glass bottles, Recall # F-483-5;
e) HDH Grillin’ Sauce packaged in 16 oz. glass bottles and
1 gallon plastic jugs, Recall # F-484-5;
f) Irish Scream BBQ Sauce packaged in 16 ounce glass
bottles and 1 gallon plastic jugs. Recall # F-495-5
CODE
All codes
RECALLING FIRM/MANUFACTURER
CaJohns Fiery Foods Company, Inc., Columbus, OH, by letter dated May 11, 2005 and by press release on May 17, 2005. Firm initiated recall is ongoing.
REASON
The products list soy sauce and Worcestershire sauce as ingredients but do not list their sub-ingredients including anchovies, soybeans and wheat.
VOLUME OF PRODUCT IN COMMERCE
(a) 719/16 ounce bottles and 51/1 gallon plastic jugs
(b) 355/16 ounce bottles and 1/1 gallon jug
(c) 349/16 ounce bottles and zero/1 gallon jug
(d) 552/16 ounce bottles
(e) 425/16 ounce bottles and zero/1 gallon jug
(f) 737/16 ounce glass bottles and zero 1 gallon jug
DISTRIBUTION
Canada
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PRODUCT
a) Deli Express Turkey & Cheese sandwich, Made with
Butterball Turkey. Contains Oven Roasted Turkey Breast
with White Turkey, Wheat Bread and Pasteurized Process
American Cheese. Net Wt 4.2 oz (119g) Keep Refrigerated
35-40F. Sandwich is packaged in modified atmosphere
small wedge plastic container with a flexible plastic
sealed cover which contains the labeling information.
Recall # F-496-5;
b) Deli Express Deli Style Stacker, containing Cured
Turkey, Wheat Bread and Pasteurized Process Cheddar
Cheese Substitute. Net Wt 4.6 oz (130g) Keep
Refrigerated 35-40F. Sandwich is packaged in modified
atmosphere small wedge plastic container with a flexible
plastic sealed cover which contains the labeling
information. Recall # F-497-5;
c) Deli Express Ham & Swiss on Rye sandwich, Made with
Armour Ham. Containing Smoked Ham-Water Added, Dark Rye
Bread and Pasteurized Process Swiss & American Cheese.
Net Wt 4.4 oz (125g) Keep Refrigerated 35-40F. Sandwich
is packaged in a modified atmosphere small wedge plastic
container with a flexible plastic sealed cover which
contains the labeling information. Recall # F-498-5;
d) Deli Express Ham & Cheese sandwich, Made with Armour
Ham. Contains Smoked Ham-Water Added, White Bread and
Pasteurized Process American Cheese. Net Wt 4.6 oz
(130g) Keep Refrigerated 35-40F. Sandwich is packaged in
a modified atmosphere small wedge plastic container with
a flexible plastic sealed cover which contains the
labeling information. Recall # F-499-5;
e) Deli Express Sub Selects Classic Ham & Cheese, Made with
Armour Ham. Contains French Roll, Smoked Ham-Water Added
and Pasteurized Process American Cheese. Net Wt 6.6 oz
(187g) Keep Refrigerated 35-40F. Sandwich is packaged in
modified atmosphere flexible plastic which contains the
labeling information. Recall # F-500-5;
f) Deli Express Turkey Club sandwich, Made with Butterball
Turkey, Contains White Bread, Oven Roasted Turkey Breast
with White Turkey and Pasteurized Process American
Cheese. Net Wt 4.4 oz (125g) Keep Refrigerated 35-40F.
Sandwich is packaged in a modified atmosphere small
wedge plastic container with a flexible plastic sealed
cover which contains the labeling information.
Recall # F-501-5;
g) Deli Express Sub Selects Traditional Italian with Spicy
Ham, Salami, Provolone Cheese & Pepperoni on a Parmesan
Roll. Net Wt 6.1 oz (173g) Keep Refrigerated 35-40F.
Sandwich is packaged in modified atmosphere flexible
plastic which contains the labeling information,
Recall # F-502-5;
h) Deli Express Chopped Ham & Cheese Sub sandwich
containing Sesame Seeded Hoagie, Chopped Ham Water
Added and Pasteurized Processed American CheeseNet
Wt 6.1 oz (173g) Keep Refrigerated 35-40F. Sandwich
is packaged in modified atmosphere flexible plastic
which contains the labeling information.
Recall # F503-5;
i) Deli Express Grilled Ham & Cheese sandwich, Made with
Armour Ham. Contains Grilled Bread, Smoked Ham-Water
Added and Pasteurized Process American Cheese. Net Wt
4.1 oz (116g) Keep Refrigerated 35-40F. Sandwich is
packaged in a modified atmosphere flexible plastic which
contains the labeling information, Recall # F-504-5
CODE
a) Product sold Wholesale identified on outside of box of
10 sandwiches with product code 779 & one of the
following manufactured dates: 01-21-2005, 01-27-2005,
02-15-2005 or 02-28-2005. Individual sandwiches are each
identified with one of the following manufacturer date
codes: 450214, 450272, 450273, 450463 or 450593.
Sandwiches distributed through Deli Express Direct Store
Delivery (DSD) are identified as product code 121, and
individual sandwiches contain a manufacturer date CODE
of 450191, 450254, 450464 or 450563;
b) Product sold Wholesale identified on outside of box of
10 sandwiches with product code 615 & manufactured date
02-28-2005, each sandwich is stamped with manufacturer
date code 450594. Product identified on outside of box
of 10 sandwiches as product code 787 and one of the
following manufactured dates: 01-25-2005, 02-11-2005,
02-23-2005, 02-24-2005 or 03-02-2005. Individual
sandwiches are each identified with one of the following
manufacturer date codes: 450252, 450422, 450542, 450551
or 450614. Sandwiches distributed through Deli Express
Direct Store Delivery (DSD) are identified as PRODUCT
code 110, and individual sandwiches contain a
manufacturer date code of 450251, 450274, 450343,
450423, 450543, 450544, 450552 or 450624;
c) Product sold Wholesale identified on outside of box of
10 sandwiches with product code 734 & manufactured date
of 02-28-2005. Individual sandwiches are each identified
with manufacturer date code 450591. Sandwiches
distributed through Deli Express Direct Store Delivery
(DSD) are identified as product code 122, and individual
sandwiches contain a manufacturer date code of either
450271, 450342, 450424 or 450462;
d) Product sold Wholesale identified on outside of box of
10 sandwiches with product code 784 & manufactured date
of either 01-21-2005, 02-01-2005 or 02-15-2005.
Individual sandwiches are each identified with one of
the following manufacturer date codes 450213, 450321,
450322 or 450461. Sandwiches distributed through Deli
Express Direct Store Delivery (DSD) are identified as
product code 124, and individual sandwiches contain a
manufacturer date code of either 450202, 450211, 450212,
450323, 450341, 450421, 450541, 450554 or 450611;
e) Product sold Wholesale identified on outside of box of
10 sandwiches with product code 889 & manufactured date
of either 02-02-2005 or 02-17-2005. Individual
sandwiches are each identified with one of the following
manufacturer date codes 450332 or 450482. Sandwiches
distributed through Deli Express Direct Store Delivery
(DSD) are identified as product code 145, and individual
sandwiches contain a manufacturer date code of either
450392, 450453, 450562 or 450622;
f) Product sold Wholesale identified on outside of box of
10 sandwiches with product code 647 & manufactured date
of either 02-16-2005 or 03-02-2005, each sandwich is
stamped with a manufacturer date code of either 450472
or 450612. Product identified on outside of box of 10
sandwiches as product code 785 and one of the following
manufactured dates: 01-19-2005, 01-25-2005, 02-01-2005,
02-16-2005 or 03-02-2005. Individual sandwiches are each
identified with one of the following manufacturer date
codes 450192, 450252, 450324, 450471 or 450613.
Sandwiches distributed through Deli Express Direct Store
Delivery (DSD) are identified as product code 157, and
individual sandwiches contain a manufacturer date CODE
of 450602;
g) Product sold Wholesale identified on outside of box of
10 sandwiches with product code 888 & manufactured date
of either 02-02-2005, 02-09-2005, 02-17-2005, 02-22-2005
or 03-03-2005. Individual sandwiches are each identified
with one of the following manufacturer date codes
450333, 450402, 450483, 450532 or 450623. Sandwiches
distributed through Deli Express Direct Store Delivery
(DSD) are identified as product code 166, and individual
sandwiches contain a manufacturer date code of either
450334, 450403, 450484, 450521 or 450534;
h) Product sold Wholesale identified on outside of box of
10 sandwiches with product code 797 & manufactured date
of either 02-08-2005, 02-14-2005, 02-25-2005 or 03-03-
2005. Individual sandwiches are each identified with one
of the following manufacturer date codes 450391, 450452,
450561 or 450621. Sandwiches distributed through Deli
Express Direct Store Delivery (DSD) are identified as
product code 169, and individual sandwiches contain a
manufacturer date code of either 450313, 450401, 450451
or 450481;
i) Product was only sold Wholesale and is identified on
outside of box of 10 sandwiches with product code 648
& manufactured date 02-07-2005. Individual sandwiches
are each identified with the following manufacturer
date code 450383
RECALLING FIRM/MANUFACTURER
Sween, E. A., Company, Eden Prairie, MN, by telephone on March 4, 2005, press release on March 9, and March 19, 2005, and by e-mail or hand delivered letter beginning March 15, 2005. Firm initiated recall is ongoing.
REASON
Sandwiches may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
752,767 individual sandwiches
DISTRIBUTION
Nationwide
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PRODUCT
Fieldcrest Chocolate Ice Cream, half-gallon cardboard rectangle cartons, 6 units shrink wrapped in a plastic sleeve; UPC 41900-02696, Recall # F-505-5
CODE
17-81 XXXX 123 L2 Best by 5/03/06, where XXXX is the time code between 2200 and 0050
RECALLING FIRM/MANUFACTURER
Recalling Firm: Midwest Ice Cream Company, Franklin Park, IL, by press release on June 9, 2005.
Manufacturer: Dean Foods, Company, Belvidere, IL. Firm initiated recall is ongoing.
REASON
Some of the chocolate ice cream has peanut butter sauce/swirl in it which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
5,442 cartons
DISTRIBUTION
IL, IN, IA, MI and WI
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PRODUCT
Palm Fan brand Dehydrated Vegetable, Net Wt. 198 g (7 oz.), Product of China, product is packaged in a sealed, clear plastic bag, Recall # F-506-5
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Great Kingsland, Inc., Brooklyn, NY, by press release and letters dated, December 2, 2004.
Manufacturer: Jiang Men City Xin Hui District Xing Hua Food Co., Ltd, Jiang Men City, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (380 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
23 cases (100 - 7 oz. bags per case)
DISTRIBUTION
NY
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PRODUCT
Jibert’s brand Vanilla Supreme Ice Cream in pint and half gallon containers, Recall # F-507-5
CODE
Lot 5053
RECALLING FIRM/MANUFACTURER
Jilbert Dairy, Inc, Marquette, MI, by press release and telephone beginning on May 11, 2005. Firm initiated recall is complete.
REASON
The product was found to be contaminated with Listeria monocytogenes based on the Michigan Department of Agriculture’s analysis.
VOLUME OF PRODUCT IN COMMERCE
717 pints and 588 half gallons
DISTRIBUTION
MI and WI
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PRODUCT
Fresh Cambray Onions in wooden crates, 32 lbs., Product of Mexico, Recall # F-511-5
CODE
NA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coliman Pacific Corp, Phoenix, AZ, by telephone and visit beginning on May 13, 2005.
Manufacturer: Frutas Finas Del Noroeste, Hermosilo, Mexico. Firm initiated recall is complete.
REASON
Onions were found to be contaminated with Salmonella based on FDA’s analysis.
VOLUME OF PRODUCT IN COMMERCE
20 crates
DISTRIBUTION
AZ
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PRODUCT
a) 7 Eleven Grilled Sandwich, Grilled Italian Deli on
Focaccia Bread with Parmesan Mayonnaise, 7.1 oz,
product code 72240, Recall # F-512-5;
b) 7 Eleven Grilled Sandwich, Grilled Chicken with Herb
Roasted Tomatoes Sandwich, 6.8 oz, product code 72259,
Recall # F-513-5;
c) 7 Eleven Big Eats Turkey, Ham, Cheddar Cheese & Bacon on
White Bread, 7.8 oz, product code 01013, Recall # F-514-
5;
d) 7 Eleven Big Eats Corned Beef & Swiss Cheese on
Sourdough Bread, 8.1 oz, product code 01066,
Recall # F-515-5;
e) 7 Eleven Big Eats Black Forest Ham and Mozzarella Cheese
on Cracked Wheat Bread with Honey Mustard Mayonnaise and
Hot Chopped Red Peppers, 8.8 oz, product code 00322,
Recall # F-516-5;
f) 7 Eleven Big Eats Turkey, Ham, & Provolone Cheese on
Tomato Basil Bread, 7.8 oz, product code 01018,
Recall # F-517-5;
g) 7 Eleven Big Eats Turkey, Ham, & Swiss Pita with
Southwestern Mayonnaise, 9.3 oz, product code 73192,
Recall # F-518-5;
h) 7 Eleven Big Eats Turkey & Cheddar Cheese Sub, 4.7 oz,
product code 72437, Recall # F-519-5;
i) 7 Eleven Big Eats Colossal Club Sub, 12.6 oz, PRODUCT
code 73444, Recall # F-520-5;
j) 7 Eleven Big Eats Ham & Swiss on Potato Roll, 2.7 oz,
product code 73895, Recall # F-521-5;
k) 7 Eleven Big Eats Smoked Turkey & Jack on Wheat Bread,
7.6 oz, product code 71795, Recall # F-522-5;
l) 7 Eleven Big Eats Smoked Turkey & Jack on Wheat Bread,
3.3 oz, product code 01064, Recall # F-523-5;
m) 7 Eleven Big Eats Turkey & Pepperjack Cheese on Potato
Roll, 2.2 oz, product code 71738, Recall # F-524-5;
n) 7 Eleven Big Eats Turkey with Zesty Havarti Cheese on
Walnut Scallion Bread with Grilled Onions and Bacon,
9.4 oz, product code 01097, Recall # F-525-5;
o) 7 Eleven Big Eats Croissant with Egg, Ham & Cheese,
4.1 oz, product code 72999, Recall # F-526-5;
p) 7 Eleven Big Eats Smoked Turkey & Spicy Pepperoni on
Tomato Basil Bread with Tomato Feta Spread,
8.8 oz, product code 01029, Recall # F-527-5;
q) 7 Eleven Big Eats Chicken Caesar on Cracked Wheat Bread,
8.5 oz, product code 00382, Recall # F-528-5;
r) 7 Eleven Big Eats Ham & Swiss Cheese Sub, 4.9 oz,
product code 70063, Recall # F-529-5;
s) 7 Eleven Big Eats Turkey & Swiss Pita, 9.5 oz, PRODUCT
code 70730, Recall # F-530-5;
t) 7 Eleven Big Eats Ham & Cheese Sandwich, 5.5 oz, PRODUCT
code 74728, Recall # F-531-5
CODE
“Handmade On” codes 0502 through 0507
RECALLING FIRM/MANUFACTURER
Prime Deli Corporation, Lewisville, TX, by press release on May 13, 2005. Firm initiated recall is ongoing.
REASON
FDA testing found Listeria monocytogenes in some sandwiches and in plant’s environment.
VOLUME OF PRODUCT IN COMMERCE
63,476 sandwiches
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

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PRODUCT
a) Gentle Jerk Marinade packaged in 12 ounce glass
bottles and 1 gallon plastic jugs. Recall # F-485-5;
b) Jumpin’ Jerk Marinade packaged in 12 ounce glass bottles
and 1 gallon plastic jugs. Recall # F-486-5;
c) Joltin’ Jerk Marinade packaged in 12 ounce glass bottles
and 1 gallon plastic jugs. Recall # F-487-5;
d) PepperYaki Habanero Marinade packaged in 12 ounce glass
bottles and 1 gallon plastic jugs, Recall # F-488-5;
e) PepperYaki Jalapeno Marinade packaged in 12 ounce glass
bottles and 1 gallon plastic jugs, Recall # F-489-5;
f) Irish Scream Hot Sauce packaged in 5 ounce glass
bottles, Recall # F-490-5;
g) Ralph’s Righteous Habanero Sauce packaged in 5 ounce
glass bottles, Recall # F-491-5;
h) Parker & Sons Bar-Be-Que Sauce Mild packaged in 16 ounce
glass bottles and 1 gallon plastic jugs,
Recall # F-492-5;
i) Parker & Sons Bar-Be-Que Sauce Spicy packaged in 16
ounce glass bottles and 1 gallon plastic jugs,
Recall # F-493-5;
j) Parker & Sons Bar-Be-Que Sauce Blazin Hot packaged in 16
ounce bottles and 1 gallon plastic jugs,
Recall # F-494-5;
CODE
All codes
RECALLING FIRM/MANUFACTURER
CaJohns Fiery Foods Company, Inc., Columbus, OH, by letter dated May 11, 2005 and by press release on May 17, 2005. Firm initiated recall is ongoing.
REASON
a), b), c), d), e) The product lists soy sauce and
Worcestershire sauce as ingredients but does not list
their sub-ingredients including anchovies, soybeans and
wheat;
f) The product contains undeclared colors - FD&C yellow #5,
yellow #6, and blue #1;
g) The product contains undeclared colors - FD&C yellow #5,
and yellow #6;
h), I), and j) The product contains undeclared color - FD&C
yellow #5 lake
VOLUME OF PRODUCT IN COMMERCE
Quantity Distributed
(a) 3151/12 ounce bottles and 98/1 gallon plastic jugs
(b) 199/12 ounce bottles and 17/1 gallon plastic jugs
(c) 128/12 ounce bottles and 13/1 gallon plastic jugs
(d) 394/12 ounce bottles and 14/1 gallon jugs
(e) 75/12 ounce bottles and zero 1 gallon plastic jug
(f) 14,465/5 ounce bottles
(g) 612/5 ounce bottles
(h) 371/16 ounce bottles and 13/1 gallon plastic jugs
(i) 371/16 ounce bottles and 13/1 gallon plastic jugs
(j) 371/16 ounce bottles and 13/1 gallon plastic jugs
DISTRIBUTION
Canada
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PRODUCT
Rainbow Trout Cakes, Ready to Cook - Saute Lightly, 60% Rainbow Trout, 4 oz (112g), Recall # F-508-5
CODE
All PRODUCT
RECALLING FIRM/MANUFACTURER
Sunburst Trout Company, Canton, NC, by telephone on June 9, 2005 and by letter on June 13, 2005. Firm initiated recall is ongoing.
REASON
The product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
30 cases (12 trout cakes per case)
DISTRIBUTION
MA and NC
______________________________
PRODUCT
Pescarich brand Frozen Yellowfin tuna. Product is frozen, vacuum packed, cold smoked tuna steaks available in 5 oz, 6 oz, 8 oz., and 10 oz. packages which are then packed in cartons weighing 10 lbs. Product of Indonesia, Recall # F-510-5
CODE
5 oz. - Codes: E16H1010, E16H1011, E16H1014 thru E16H1018;
6 oz. - Codes: E16H1009 thru E16H1011, E16H1014 thru
E16H1019; 8 oz - Codes: E16H1009, E16H1011, E16H1014 thru E16H1019; 10 oz. - Codes: E16H1015 thru E16H1018
RECALLING FIRM
Empress International Ltd, Port Washington, NY, by telephone on or about January 11, 2005. Firm initiated recall is complete.
REASON
The tuna steaks were found to contain elevated levels of histamine and were associated with several reports of histamine reactions.
VOLUME OF PRODUCT IN COMMERCE
5 oz/25 x 10 lbs. Cartons, 6 oz/402 x 10 lbs. Cartons, 8 oz./300 x 10 lbs. Cartons, 10 oz/130 x 10 lbs. cartons
DISTRIBUTION
NY, RI, CT, NJ, PA, MD, GA, FL, OH, MI, NE, LA, TX
_______________________________
PRODUCT
Resource Vanilla Artificially Flavored Dairy Thick Nector Consistency, Product further labeled as “A delicious ready-to-serve thickened beverage for the dietary management of swallowing problems”, Recall # F-532-5
CODE
0485C, 0485D, 0495C, 0495D, 0505C, and 0505D
RECALLING FIRM/MANUFACTURER
Novartis Nutrition Corporation, St. Louis Park, MN, by letter dated April 7, 2005. Firm initiated recall is ongoing.
REASON
Potential risk of aspiration and associated complications due to decreased viscosity in a medical food product used in the dietary management of institutionalized dysphagic individuals.
VOLUME OF PRODUCT IN COMMERCE
6,568 cases (27 briks per case)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

______________________________
PRODUCT
Sun Dried Tomato Halves in 5 lb. bags. The product is shipped 4 bags per box, Recall # F-509-5
CODE
809700
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dutch Valley Food Distributors, Inc., Myerstown, PA, by telephone on May 17, 2005.
Manufacturer: Woodland Foods Ltd, Gurnee, IL. Firm initiated recall is complete.
REASON
The product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

_______________________________
PRODUCT
a) MAGNESIUM SULFATE 1 g (2 ml of 50% Injection) added to
50 ml 5% Dextrose Injection USP Qty. 24 C.O.M.P.A.S.S.
NDC # 61553-410-41, Recall # D-394-5;
b) MAGNESIUM SULFATE 2 g (4 ml of 50% Injection) added to
50 ml 5% Dextrose Injection USP C.O.M.P.A.S.S. NDC #
61553-411-41, Recall # D-395-5;
c) MAGNESIUM SULFATE 4 g (8 ml of 50% Injection) added to
50 ml 5% Dextrose Injection USP C.O.M.P.A.S.S. NDC #
61553-412-41, Recall # D-396-5;
d) MAGNESIUM SULFATE 6 g (12 ml of 50% Injection) added to
50 ml 5% Dextrose Injection USP C.O.M.P.A.S.S. NDC #
61553-413-41, Recall # D-397-5;
e) MAGNESIUM SULFATE 3 g (6 ml of 50% Injection) added to
50 ml 5% Dextrose Injection USP C.O.M.P.A.S.S. NDC #
61553-419-41, Recall # D-398-5
CODE
a) Service Code: 2K2410, all lots remaining in expiry life;
b) Service Code: 2K2411, all lots remaining in expiry life;
c) Service Code: 2K2412, all lots remaining in expiry life;
d) Service Code: 2K2413, all lots remaining in expiry life;
e) Service Code: 2K2419, all lots remaining in expiry life
RECALLING FIRM/MANUFACTURER
Recalling Firm: PharMedium Services, LLc, Lake Forest, IL, by telephone on March 16, 2005, and by letter between March 21-24, 2005.
Manufacturer: PharMedium Services, LLc, Houston, TX. Firm initiated recall is ongoing.
REASON
Bacterial contamination of an injectable product, product not labeled as sterile.
VOLUME OF PRODUCT IN COMMERCE
116,328 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) Metronidazole Tablets, USP, 250 mg, NDC #53265-374-10,
NDC # 53265-374-70, and NDC # 53265-374-50, (100s, 250s,
500s), Recall # D-327-5;
b) Metronidazole Tablets, USP, 500 mg, NDC #53265-375-60,
NDC # 53265-375-10, and NDC # 53265-375-50, (60s, 100s,
500s), Recall # D-328-5;
c) Metronidazole Capsules, 375 mg, NDC #53265-353-05,
(50s,) Recall # D-329-5;
d) Metronidazole Extended-Release Tablets, 750 mg, NDC
# 53265-352-03, (30s), Recall # D-330-5
CODE
All lots being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
54 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Nitroglycerin Tablets, USP, 0.3 mg, NDC # 53265-249-10
(100s), Recall # D-331-5;
b) Nitroglycerin Tablets, USP, 0.4 mg, NDC # 53265-250-04
and NDC # 53265-250-10. (25s and 100s), Recall # D-332-
5;
c) Nitroglycerin Tablets, USP, 0.6 mg, NDC # 53265-251-10
(100s), Recall # D-333-5
CODE
All lots being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
310 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Tramadol Hydrochloride Tablets, 50 mg, NDC # 0172-6515-60, NDC # 0172-6515-70 and NDC # 0172-6515-10 (100s, 500s and 100 count unit dose tablets), Recall # D-336-5
CODE
All codes being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
49 lots
DISTRIBUTION
FL
_______________________________
PRODUCT
a) Theophylline Extended-Release Tablets, 400 mg,
NDC # 53265-380-10, NDC # 53265-380-50.
(100s and 500s), Recall # D-337-5;
b) Theophylline Extended-Release Tablets, 600 mg,
NDC # 53265-382-10, (100s), Recall # D-338-5
CODE
All codes being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
22 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate Capsules, (CIII), 50 mg/325 mg/40 mg/30 mg, NDC # 53265-240-10, (100s), Recall # D-339-5
CODE
All codes being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
6 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Prochlorperazine Suppository, USP, 2.5 mg,
NDC # 53265-243-12, 12 Pediatric-Size
Suppositories, Recall # D-340-5;
b) Prochlorperazine Suppository, USP, 5 mg,
NDC # 53265-244-12, 12 suppositories for older
Children (not under 40 lbs.), Recall # D-341-5;
c) Prochlorperazine Suppository, USP, 25 mg,
NDC # 53265-245-12, 12 Adult Suppositories. Note:
Not for Use in Children, Recall # D-342-5
CODE
All codes being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by press release and letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
16 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Promethazine Hydrochloride Suppository, USP, 12.5 mg,
12 Rectal Suppositories, For Rectal Use Only,
Rx only, NDC # 53265-762-12, Recall # D-343-5;
b) Promethazine Hydrochloride Suppository, USP, 25 mg,
12 Rectal Suppositories, For Rectal Use Only, Rx only,
NDC # 53265-763-12, Recall # D-344-5;
c) Promethazine Hydrochloride Suppository, USP, 50 mg,
12 Rectal Suppositories, For Rectal Use Only, Rx only,
NDC # 53265-764-12, Recall # D-345-5;
d) Promethazine Hydrochloride Tablets, USP, 12.5 mg,
100 count bottles, Rx only, NDC # 53265-405-10,
Recall # D-346-5;
e) Promethazine Hydrochloride Tablets, USP, 25 mg,
100 and 1000 count bottles, Rx only, NDC # 53265-406-10
and NDC 53265-406-11, Recall # D-347-5;
f) Promethazine Hydrochloride Tablets, USP, 50 mg,
100 count bottles, Rx only, NDC # 53265-405-10,
Recall # D-348-5
CODE
All lots being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
159 lots
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Children’s Tylenol Soft-Chews Fruit Flavor, 80 mg, 60 and 96 counts blister, OTC, Recall # D-349-5
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA, by press release on June 3, 2005.
Manufacturer: McNeil Consumer and Specialty Pharmaceuticals, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
The blister package design, as well as the information on the blisterpackage and on the blister and bottle cartons may be confusing and could lead to improper dosing, including over-dosing.
VOLUME OF PRODUCT IN COMMERCE
185,472 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Phenazopridine HCl Tablets, USP 100 mg,
100 and 1000 count bottles, Rx Only,
NDC # 53265-196-10, and 53265-196-11, Also
Labeled as Pyridium Tablets 100 mg, Pfizer, Inc,
Recall # D-351-5;
b) Phenazopridine HCl Tablets, USP 95 mg, (Bulk),
Recall # D-352-5;
c) Phenazopridine HCl Tablets, USP 200 mg,
100 and 1000 count bottles, NDC # 53265-197-10,
and 53265-197-11, Also Labeled as Pyridium Tablets
200 mg, Pfizer, Inc, Recall # D-353-5
CODE
All codes being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
108 lots
DISTRIBUTION
Nationwide. The product was shipped in bulk to Pfizer, Inc, NY, NY for distribution under their label to Canada, South America and Indonesia.
_______________________________
PRODUCT
a) Jr. Tylenol Meltaways Bubblegum Burst, 160 mg,
24 counts blister, OTC, Recall # D-354-5;
b) Children’s Tylenol Meltaways Bubblegum Burst
Flavor, 80 mg, 48 and 64 counts blister, OTC,
Recall # D-355-5;
c) Jr. Tylenol Meltaways Grape, 160 mg, 24 and
48 counts blister, OTC, Recall # D-356-5;
d) Children’s Tylenol Meltaways Bubblegum Burst
Flavor, 80 mg, 30 counts bottles, OTC,
Recall # D-357-5;
e) Children’s Tylenol Meltaways Watermelon Flavor,
80 mg, 30 counts bottles, OTC, Recall # D-358-5;
f) Children’s Tylenol Meltaways Grape Flavor, 80 mg,
30 counts bottles, OTC, Recall # D-359-5
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA, by Press Release on June 3, 2005.
Manufacturer: McNeil Consumer and Specialty Pharmaceuticals, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
The blister package design, as well as the information on the blister package and on the blister and bottle cartons may be confusing and could lead to improper dosing, including over-dosing.
VOLUME OF PRODUCT IN COMMERCE
10,485,008
DISTRIBUTION
MS, PS, USVI, CA, Bermuda, Guam and Cayman
_______________________________
PRODUCT
a) Andehist NR Syrup, Antihistamine/Decongestant,
Brompheniramine Maleate 4 mg, Pseudoephedrine
Hydrochloride, 45 mg, NDC # 60258-434-16, 16 fl. oz.
Recall # D-360-5;
b) Andehist NR oral Drops, Antihistamine/Decongestant,
Carbinoxamine Maleate 1 mg, Pseudoephedrine
Hydrochloride, 15 mg, NDC # 60258-435-30, 1 fl. oz
Recall # D-361-5;
c) Andehist-DM NR Syrup, Antihistamine/Decongestant/
Antitussive, Brompheniramine Maleate 4 mg,
Pseudoephedrine Hydrochloride, 45 mg, Dextromethorphan
Hydrobromide, 15 mg, NDC # 60258-444-16, 16 fl. oz,
Recall # D-362-5;
d) Bromhist-DM Drops, Brompheniramine Maleate 1 mg,
Pseudoephedrine Hydrochloride, 15 mg, Dextromethorphan
Hydrobromide, 4 mg, NDC # 60258-447-30, 1 fl. oz,
Recall # D-363-5
CODE
All lots being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by letter on May 25, 2005.
Manufacturer: Liquisource, Inc, (Able Laboratories), New Brunswick, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
4 lots
DISTRIBUTION
MS
______________________________
PRODUCT
a) DYTAN Suspension, Each 4 mL (one teaspoonful)
contains: Diphenhydramine Tannate 25 mg, Rx Only,
NDC 63717-570-99 (Professional sample: Not to be
sold) and NDC # 63717-570-04, (1/2 fl. oz. and
4 fl. oz.), Recall # D-364-5;
b) DYTAN-D, Suspension, Each 5 mL (one teaspoonful)
contains: Diphenhydramine Tannate 25 mg, Phenylephrine
Tannate 7.5 mg, Rx Only, NDC 63717-576-99 (Professional
Sample) and NDC # 63717-576-04, (1/2 fl. oz. and
4 fl. oz.), Recall # D-365-5
CODE
All lots being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Able Laboratories, Inc, Cranbury, NJ, by letter on May 25, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
There is a lack of assurance that testing for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
2 lots
DISTRIBUTION
MS
_______________________________
PRODUCT
Furosemide Tablets, USP, 20 mg, 1000 count bottles, Rx only, NDC # 0591-3436-10, Recall # D-366-5
CODE
Lot No. T055L04A, Exp 12/06
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, LLC, Huntsville, AL, by letter on June 14, 2005. Firm initiated recall is ongoing.
REASON
Mold growth on PRODUCT
VOLUME OF PRODUCT IN COMMERCE
5,064 bottles of 1000
DISTRIBUTION
CA
______________________________
PRODUCT
a) Hydrocodone Bitartrate & Acetaminophen Tablets,
USP, 5 mg/500 mg, NDC # 55154-5549-0, assist bags
of 10 tablets, Recall # D-367-5;
b) Hydrocodone Bitartrate & Acetaminophen Tablets,
USP, 7.5 mg/500 mg, NDC # 55154-5486-0, assist bags
of 10 tablets, Recall # D-368-5;
c) Hydrocodone Bitartrate & Acetaminophen Tablets,
USP, 7.5 mg/750 mg, NDC # 55154-5480-0, assist bags
of 10 tablets, Recall # D-369-5
CODE
a) Lot number 4C904A, exp. date 9/05;
Lot number 4C904B, exp. date 9/05;
Lot number 4D247A, exp. date 12/05;
Lot number 4D247B, exp. date 12/05;
Lot number 4D247C, exp. date 12/05;
Lot number 4D265A, exp. date 12/05;
Lot number 4F055A, exp. date 10/05;
Lot number 4F055B, exp. date 10/05;
Lot number 4F055C, exp. date 10/05;
Lot number 4J390A, exp. date 1/06;
Lot number 4J390B, exp. date 1/06;
Lot number 4M601A, exp. date 3/06;
Lot number 4M601B, exp. date 3/06;
Lot number 4M643A, exp. date 3/06;
Lot number 4V011A, exp. date 4/06;
Lot number 4V011B, exp. date 4/06;
Lot number 4V077A, exp. date 6/06;
Lot number 4V077B, exp. date 6/06;
Lot number 4V077C, exp. date 6/06;
Lot number 5B231A, exp. date 7/06;
Lot number 5B304A, exp. date 8/06;
Lot number 5C449A, exp. date 9/06;
b) Lot number 4H111A, exp. date 11/05;
Lot number 4H111B, exp. date 11/05;
Lot number 4H111C, exp. date 11/05;
Lot number 4H111D, exp. date 11/05;
Lot number 4H111E, exp. date 11/05;
Lot number 4H111F, exp. date 11/05;
Lot number 4H111G, exp. date 11/05;
Lot number 4H111H, exp. date 11/05;
Lot number 4H111J, exp. date 11/05;
Lot number 4D258A, exp. date 12/05;
Lot number 4D258B, exp. date 12/05;
Lot number 4K516A, exp. date 2/06;
Lot number 4K516B, exp. date 2/06;
Lot number 4K516C, exp. date 2/06;
Lot number 4K516D, exp. date 2/06;
Lot number 4K516E, exp. date 2/06;
Lot number 4K516F, exp. date 2/06;
Lot number 4P804A, exp. date 4/06;
Lot number 4P804B, exp. date 4/06;
Lot number 4P804C, exp. date 4/06;
Lot number 4P804D, exp. date 4/06;
Lot number 4V024A, exp. date 6/06;
Lot number 4V024B, exp. date 6/06;
Lot number 5C390A, exp. date 9/06;
c) Lot number 4V990A, exp. date 6/06;
Lot number 5C474A, exp. date 9/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Zanesville, OH, by letter dated June 1, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
Recalled at the request of the manufacturer, because of serious concerns that the products were not produced according to quality assurance standards.
VOLUME OF PRODUCT IN COMMERCE
21,400 bags/10 tablet blisters
DISTRIBUTION
OH
_______________________________
PRODUCT
a) Indomethacin extended release capsules,
USP 75 mg, 60 count bottles, NDC # 62584-312-60,
Recall # D-371-5;
b) Propoxyphene Napsylate and Acetaminophen tablets,
USP 100 mg/650 mg tablets, Packaged in 100 count
box (each box containing 10 blister cards x 10
tablets per card), NDC # 62584-919-01,
Recall # D-372-5;
c) Propoxyphene Napsylate and Acetaminophen tablets,
USP 100 mg/650 mg tablets, Packaged 450 count
box (packaged as 15 cards containing 30 tablets per
card), NDC # 62584-919-85, Recall # D-373-5;
d) Lithium Carbonate Capsules, USP, 300 mg, NDC #68084-
042-01, package in 100 count box (each box containing
10 blister cards x 10 tablets per card),
Recall # D-374-5
CODE
All lots are being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by letters, dated May 27, 2005 and June 21, 2005.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
Recalled at the request of the manufacturer, because of serious concerns that the products were not produced according to quality assurance standards.
VOLUME OF PRODUCT IN COMMERCE
a) 34,400 bottles
b) 11,656/100 count cartons
c) All lots
d) 451/100 count boxes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Perfection Tablets, All New Dietary Food Supplement
with Chromium, (Phenylpropanolamine HCl), 25mg (appetite
suppressant, time release), 120 count bottles,
Formulated by Physicians Research Laboratories,
Recall # 375-5;
b) The Perfect Solution, GARPRIN Tablets, All Natural
Dietary Food Supplement, For The Heart, Pharmaceutical
Grade, 60 count bottles, each tablet contains: Garlic
Odorless 325 mg, White WIllow Extract 100 mg, Asprin 93
mg, Magnesium Stearate, Recall # D-376-5
CODE
All lots
RECALLING FIRM/MANUFACTURER
Physicians Research Laboratories, Hermitage, TN, by telephone beginning on June 2, 2005. Firm initiated recall is complete.
REASON
a) Unapproved New Drug; product contains
Phenylpropanolamine;
b) Unapproved New Drug; product contains Aspirin
VOLUME OF PRODUCT IN COMMERCE
a) 50 bottles;
b) 11 bottles
DISTRIBUTION
Nationwide
______________________________
PRODUCT
AZO Standard Phenazopyridine Hydrochloride 95 mg tablets packaged in cellophane blister strip packs in cartons of 12’s and 30’s. Recall # D-383-5
CODE
205070 205071 207013 207014 207015 207016 207017 301011 301012 301013 303088 303089 304175 304176 304177 308102 308103 310032 310033 401192 401194 402002 402004 308100 308101 401193, 401193-WI, 402001, 402003, 402003-WI, A301 A402, A405, A408
RECALLING FIRM/MANUFACTURER
Recalling Firm: Polymedica Pharmaceuticals (USA) Inc, Woburn, MA, by letter dated on June 22, 2005.
Manufacturer: Able Laboratories, Inc., South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
Product may not meet quality standards.
VOLUME OF PRODUCT IN COMMERCE
3 million units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Indomethacin Extended Release Capsules, 75 mg.; an Rx
oral nonsteroidal anti-inflammatory; the capsules were
packaged in the following configurations: Product no.
1518-0: 30 capsules, Product no. 1518-2: 14 capsules,
Product no. 1518-3: 20 capsules; NDC #53265-0269-10,
Recall # D-386-5;
b) Promethazine HCL Tablets, 25 mg.; an Rx oral
antiemetic/antivertigo agent; the tablets were packaged
in the following configurations: Product no. 1754-0: 12
tablets, Product no. 1754-1: 10 tablets, Product no.
1754-6: 20 tablets, Product no. 1754-8: 2 tablets,
Product no. 1754-9: 30 tablets, Product no. 4168-0: 5
tablets; NDC #53265-0406-10 and 53265-0406-11, Recall #
D-387-5;
c) Hydrocortisone Acetate Suppositories, 25 mg.; an Rx
rectal anti-inflammatory; the suppositories were
packaged 12 per carton, Product no. 2586-0, NDC #53265-
761-12, Recall # D-388-5;
d) Naproxen Sodium Tablets, 275 mg.; an Rx oral
nonsteroidal anti-inflammatory; the tablets were
packaged in the following configurations: Product no.
3761-0: 20 tablets, Product no. 3761-2: 30 tablets,
Product no. 3761-4: 14 tablets; NDC #53265-0363-10,
Recall # D-389-5
e) Naproxen Sodium Tablets, 550 mg.; an Rx oral
nonsteroidal anti-inflammatory; the tablets were
packaged in the following configurations: Product no.
3762-2: 16 tablets, Product no. 3762-3: 20 tablets,
Product no. 3762-4: 21 tablets, Product no. 3762-5: 30
tablets, Product no. 3762-7: 14 tablets; NDC #53265-
0364-10 and 53265-0364-50, Recall # D-390-5;
f) Prochlorperazine Suppositories, 25 mg.; an Rx rectal
anti-emetic; the suppositories were packaged 12 per
carton, Product no. 4720-0, and 3 per carton, PRODUCT
no. 4720-2; NDC #53265-245-12, Recall # D-391-5;
g) Clorazepate Dipotassium Tablets, 15 mg.; an Rx oral
Schedule C-IV narcotic tranquilizer; the capsules were
packaged 12 tablets per bottle, Product no. 4586-1; NDC
#53265-0050-10, Recall # D-392-5;
h) Acetaminophen/Hydrocodone Tablets, 325 mg/5 mg.; each
tablet contains 325 mg. acetaminophen and 5 mg.
hydrocodone bitartrate; an Rx oral Schedule C-III
narcotic analgesic; the tablets were packaged in the
following configurations: Product no. 5523-0: 20
tablets, Product no. 5523-1: 10 tablets; NDC #53265-
0345-10 and 53265-0345-50, Recall # D-393-5
CODE
a) Lot no’s: 1518-0: 30 capsules, lots 5061164, 5059120,
4352010, 4351012, 4310016, 4286128, 4181219;
Lot no’s: 1518-2: 14 capsules, lots 5011138, 4293139,
4287171, 4275220, 4252178, 4239082, 4233071;
Lot no’s: 1518-3: 20 capsules, lots 5081122, 5018202,
4296012, 4293215, 4211024, 4184021;
b) Lot no’s: 1754-0: 12 tablets, lots 5081104, 5034132,
4336118;
Lot no’s: 1754-1: 10 tablets, lots 5119018, 5059212,
5059170, 5012116, 4282010;
Lot no’s: 1754-6: 20 tablets, lots 5075141, 5007010;
Lot no’s: 1754-8: 2 tablets, 5011200, 4343148,
4322184;
Lot no’s: 5105023, 5052147, 4329031;
Lot no’s: 4168-0: 5 tablets, 5059173, 4317015;
c) Lot no’s: 510982, 5087159, 5041208, 5025192, 4336143,
4324033, 4314175, 4302031, 4271064, 4247046,
4205053, 4189169, 4177050, 4126092, 4110131,
4098145, 4093058, 4065043, 4055252, 4042112,
4037042, 3335171, 3323163, 3275104;
d) Lot no’s: 5028018, 5028019, 5004180, 4302049;
Lot no’s: 5124222, 5122215, 4316020;
Lot no’s: 5063097, 5039286, 4349219, 4322117;
e) Lot no’s: 5133016, 5062140;
Lot no’s: 5133017, 5075216, 5069164, 4328072;
Lot no’s: 5013121, 4363121;
Lot no’s: 5105008, 5053197;
Lot no’s: 5067184, 4350160;
f) Lot no's: 5136195, 5111193, 5089185, 5084104, 5046150,
5038196, 5033119, 5025125, 4358077, 4356255, 4337065,
4334241, 4328084, 4323077, 4253038, 4253039, 4229146,
4216160, 4216159, 4208224, 4205088, 4111138, 4111139,
4070159, 4070160, 4055221, 4029064, 4013143;
Lot no's: 5138151, 5136196, 5055248, 5026164, 5012156,
4344061, 4322169, 4301166, 4223148, 4223147, 4132175,
4106055, 4091166, 4091165, 4042127;
g) Lot no's: 5104004, 5090012, 5052111, 5011130, 4364154,
4321110, 4132052, 4077066;
h) Lot no’s: 5066163, 5046118, 5033133, 4253011, 4132127,
4068082, 3345017, 3343008, 3272145;
Lot no’s: 5124161, 5066179, 4316024, 4153172, 4089011,
4068131, 4013087, 3360002, 3288116, 3283003, 3272147
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allscripts LLC, Libertyville, IL, by letters dated May 26, 2005.
Manufacturer: Able Laboratories, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
Allscripts repackaged products being recalled by the manufacturer, Able Laboratories, due to a lack of assurance that testing conducted for release and stability conformed to standard operating procedures.
VOLUME OF PRODUCT IN COMMERCE
10,828 capsules, 280,456 tablets, 11,976 suppositories
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) The Master’s Miracle 1st Edition Video, Recall # D-399-5;
b) Natural Solutions for Optimum Health & Wealth (The
Master’s Miracle Cassette), Recall # D-400-5;
c) The Master’s Miracle 2nd Edition Video, Recall # D-401-5;
d) Booklet - Secrets of pH/Dr. Cochran, Recall # D-402-5;
e) Video - Testimonial, Recall # D-403-5;
f) Booklet - Master’s Miracle Product Usage (White Booklet),
Recall # D-404-5;
g) Booklet - Secrets of pH/Dr. Cochran, Recall # D-405-5;
h) Cassette - pH Miracle/Dr. Cochran, Recall # D-406-5;
i) Cassette - Training School 101, Recall # D-407-5;
j) DVD - Making A Difference DVD 2003, Recall # D-408-5;
k) Video- The Master’s Miracle 3rd Edition,
Recall # D-409-5;
l) Cassette - Product & Opportunity Testimonials 2004,
Recall # D-410-5;
m) CD- Product & Opportunity Testimonials 2004,
Recall # D-411-5
CODE
a) Product ID 7703, 7704, 7913, discontinued date 08/2003;
b) Product ID 7701, 7688, 8975, discontinued date 02/2004;
c) Product ID 7703, 7704, 7913, discontinued date 02/2004;
d) Product ID 8904, 8905, 8908, discontinued date 03/2004;
e) Product ID 8984, 8985, discontinued date 04/2004;
f) Product ID 7698, discontinued date 04/2004;
g) Product ID 10925, 10936, 10937, discontinued date
11/2004;
h) Product ID 7896, 7904, 7905, discontinued date 11/2004;
i) Product ID 7918, 7923, 8038, discontinued date 11/2004;
j) Product ID 9851, discontinued date 02/2005;
k) Product ID 7703,7705, 7913, discontinued date 02/2005;
l) Product ID 11571, 11572, 11573, discontinued date 02/2005;
m) Product ID 11574, 11575, 11576, discontinued date 05/2005
RECALLING FIRM/MANUFACTURER
The Master’s Miracle, Maple Grove, MN, by press release on May 18, 2005, email beginning May 21, 2005 and May 27, 2005. Firm initiated recall is ongoing.
REASON
Misbranded: promotional material makes unapproved drug claims.
VOLUME OF PRODUCT IN COMMERCE
329,028 units
DISTRIBUTION
Nationwide and Canada
_______________________________
PRODUCT
a) ACETAMINOPHEN/CODEINE NO.3 Tablets, (CODEINE PHOSPHPHATE
30 mg (WARNING: MAY BE HABIT FORMING.) and ACETAMINOPHEN
300 mg), 30 Tablet bottles, NDC 54868-0072-1,
Recall # D-412-5;
b) PROPOXYPHENE NAPSYLATE/ACETAMINOPHEN (TABLETS, USP),
100mg/650mg, 15, 20, 30, 40 and 50 Tablet bottles,
NDC 54868-0073-1, 30 tablets; NDC 54868-0073-3, 15
tablets; NDC 54868-0073-4, 20 tablets; NDC 54868-0073-5,
50 tablets; NDC 54868-0073-7, 40 tablets; and NDC 54868-
0073-9, Relabel only, Recall # D-413-5;
c) HYDROXYZINE HCL, (HYDROXYZINE HCl Tablets, USP), 25 mg,
10 and 30 Tablet bottles, NDC 54868-0063-3, 30 tablets;
and NDC 54868-0063-9, 10 tablets, Recall # D-414-5;
d) INDOMETHACIN, (INDOMETHACIN CAPSULES, USP), 25 mg, 30
and 60 Capsule bottles, NDC 54868-0074-3 25 mg 30
capsules; NDC 54868-0074-5 25 mg 60 capsules, Recall #
D-415-5;
e) PHENAZOPYRIDINE, (PHENAZOPYRIDINE HCL TABLETS, USP), 100
mg, 10, 20 and 30 Tablet bottles, NDC 54868-0249-0 100
mg, 10 tablets; NDC 54868-0249-2 100 mg, 30 tablets; NDC
54868-0249-3 100 mg, 20 tablets, Recall # D-416-5;
f) PROMETHAZINE 12.5 mg Supp, NDC 54868-4794-0, Relabel
only, Recall # D-417-5;
g) METHYLPHENIDATE HYDROCHLORIDE, (METHYLPHENIDATE HCL
TABLETS, USP), 10 mg, 25 Tablet bottles, NDC 54868-0733-
5 10 mg, 25 tablets, Recall # D-418-5;
h) CARISOPRODOL, (CARISOPRODOL TABLETS, USP), 350 mg, 20,
30, 50, 60 and 90 Tablet bottles, NDC 54868-0816-2 350
mg, 20 tablets; NDC 54868-0816-3 350 mg, 30 tablets; NDC
54868-0816-4 350 mg, 60 tablets; NDC 54868-0816-5 350
mg, 50 tablets; NDC 54868-0816-8 350 mg, 90 tablets; and
NDC 54868-0816-6 350 mg, Relabel only, Recall # D-419-5;
i)INDOMETHACIN SR, (INDOMETHACIN CAPSULES, USP), EXTENDED
RELEASE CAPSULES, 75 mg, 15 and 30 Capsule bottles, NDC 54868-0922-1 75 mg, 30 capsules; NDC 54868-0922-7 75 mg, 15 capsules; and NDC 54868-0922-2 75 mg, Relabel only, Recall # D-420-5;
j) BUTALBITAL COMPOUND/APAP, (BUTALBITAL, USP 50 mg
(WARNING: MAY BE HABIT FORMING.), APAP (ACETAMINOPHEN)
325 mg, CAFFEINE, USP 40 mg), 30 Tablet bottles, NDC
54868-1036-1 30 tablets, Recall # D-421-5;
k) LITHIUM CARBONATE EXTENDED RELEASE TABLETS, USP, 300 mg,
60 tablet bottles, NDC 54868-5239-0 60 tablets, Recall #
D-422-5;
l) PROMETHAZINE, (PROMETHAZINE HYDROCHLORIDE TABLETS, USP),
12.5 mg, 10 and 15 Tablet bottles, NDC 54868-5121-0 12.5
mg 15 tablets; NDC 54868-5121-1 12.5 mg 10 tablets,
Recall # D-423-5;
m) METHAMPHETAMINE HYDROCHLORIDE, (METHAMPHETAMINE HCL
TABLETS, USP), 5 mg, 60 Tablet bottles, NDC 54868-5136-0
5 mg 60 tablets, Recall # D-424-5;
n) HYDROCODONE/ACETAMINOPHEN, (HYDROCODONE BITARTRATE 5 mg
(WARNING: MAY BE HABIT FORMING) ACETAMINOPHEN 325 mg
TABLETS, USP), 30 Tablet bottle, NDC 54868-5146-0
5mg/325mg 30 tablets, Recall # D-425-5;
o) HYDROCODONE BITART/ACET, HYDROCODONE BITARTRATE 7.5 MG
(WARNING: MAY BE HABIT FORMING) ACETAMINOPHEN 325 MG
TABLETS, USP), 30 TABLET BOTTLES, NDC 54868-5167-0
7.5mg/325mg 30 tablets, Recall # D-426-5;
p) LITHIUM CARBONATE 300 mg, NDC 54868-1335-2 (Relabel
only), Recall # D-427-5;
q) INDOMETHACIN, (INDOMETHACIN CAPSULES, USP), 50 mg, 20,
30 and 40 Capsule bottles, NDC 54868-0875-2 50 mg 30
capsules; NDC 54868-0875-4 50 mg 40 capsules; NDC 54868-
0875-6 50 mg 20 capsules,Recall # D-428-5;
r) PHENAZOPYRIDINE (PHENAZOPYRIDINE HCL TABLETS, USP), 200
mg, 5, 6, 10, 15, 20 and 30 Tablet bottles, NDC 54868-
0250-1 200 mg, 10 tablets; NDC 54868-0250-2 200 mg, 20
tablets; NDC 54868-0250-4 200 mg, 5 tablets; NDC 54868-
0250-6 200 mg, 6 tablets; NDC 54868-0250-7 200 mg, 15
tablets; and NDC 54868-0250-8 200 mg, 30 tablets,
Recall # D-429-5;
s) PROMETHAZINE HCL SUPPOSITORIES USP, 25 mg, 2 and 6
Suppositories, NDC 54868-0601-0 25 mg, 6 suppositories;
NDC 54868-0601-1 25 mg, 2 suppositories, Recall # D-
430-5;
t) PROMETHAZINE, PROMETHAZINE HCL USP SUPPOSITORIES, 50 mg,
4 Suppositories, FOR RECTAL ADMINISTRATION, NDC 54868-
1613-1 50 mg, 4 suppositories,Recall # D-431-5;
u) PROMETHAZINE (PROMETHAZINE HYDROCHLORIDE TABLETS, USP),
25 mg, 10, 15, 20, and 30 tablet bottles, NDC 54868-
1323-1 25mg 10 tablet; NDC 54868-1323-4 25 mg 15
Tablets; NDC 54868-1323-5 25mg 20 tablets; NDC 54868-
1323-6 25mg 30 tablets; NDC 54868-1323-0 (Relabel only),
Recall # D-432-5
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Physicians Total Care, Inc, Tulsa, OK, by letters on June 10, 2005.
Manufacturer: Able Laboratories, Inc, South Plainfield, NJ. Firm initiated recall is ongoing.
REASON
Lack of assurance that testing done for release and stability conformed to standard operating procedures (by Able Labs)
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
______________________________
PRODUCT
Vinorelbine Tartrate Injection, 10mg/mL, 1 and 5 mL vials, For Intravenous Use Only, Rx only, NDC 10019-970-02 ---- Also under other brand as Vinorelbine Tartrate Injection, 10mg/mL, ESI Lederle, Recall # D-264-5
CODE
1mL lots: 601248 exp 7/05; 601416 exp 11/05; A71275 exp 6/06; A93267 exp 8/06. 5mL lots: 601216 exp 7/05; 601217 exp 7/05; 601218 exp 7/05; 601219 exp 7/05; 601412 exp 8/05; A71276 exp 3/06; A71277 exp 3/06; A71278 exp 4/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Anesthesia and Critical Care, New Providence, NJ, by letter on May 23, 2005.
Manufacturer: Wyeth Parenterals, Division of Wyeth Holdings Corp, Carolina, PR. Firm initiated recall is ongoing.
REASON
Exceeds Impurity Level
VOLUME OF PRODUCT IN COMMERCE
54,505/1 mL vials; 33,055/5 mL vials
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Tebamide Suppositories (Trimethobenzamide HCl
Suppositories w/Benzocaine). Package size: 10s
And 50s, Rx product, 200 mg, (Adult), Adult
contains 200 mg trimethobenzamide hydrochloride
and 2% benzocaine. Recall # D-334-5;
b) Tebamide Suppositories (Trimethobenzamide Hci
suppositories w/Benzocaine). Package size: 10s,
Rx product, 100 mg, (Pediatric). Pediatric contains
100 mg trimethobenzamide hydrochloride and 2%
benzocaine, Recall # D-335-5
CODE
a) Lot 010804001 (exp 1/06)
Lot 010804002 (exp 2/06)
Lot 010804003 (exp 10/05)
b) Lot 010704001 (exp 9/05)
RECALLING FIRM/MANUFACTURER
G & W Labs, Inc., South Plainfield, NJ, by letters on May 9, 2005. Firm initiated recall is ongoing.
REASON
Failure to meet assay specs through expiration date for benzocaine.
VOLUME OF PRODUCT IN COMMERCE
85,764 boxes
DISTRIBUTION
Nationwide
______________________________
PRODUCT
Premarin (conjugated estrogens) USP, 1.25 mg, 100 count tablet bottles, NDC # 0046-0866-81, Recall # D-370-5
CODE
Lot 034038B, expiration date July 31, 2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by letters, dated June 13, 2005.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Product does not conform to the current USP dissolution specifications for Conjugated Estrogens.
VOLUME OF PRODUCT IN COMMERCE
10,658/100 tablet bottles
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Climara Pro (Estradiol/Levonorgestrel Transdermal System) 0.045/0.015 mg/day. Rx only, Recall # D-384-5
CODE
Lot 040731, Exp. 10/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Berlex, Inc, Wayne, NJ, by letter on May 25, 2005.
Manufacturer: 3M Pharmaceuticals, St. Paul, MN. Firm initiated recall is ongoing.
REASON
Mispackaging: Within the batch, pouches with “Sample-Not For Sale” labeling is intermingled with correct trade foil pouches.
VOLUME OF PRODUCT IN COMMERCE
40,931 cartons
DISTRIBUTION
Nationwide
______________________________
PRODUCT
HYDROCODONE BITARTRATE AND ACETAMINOPHEN CAPSULES, 5 mg/500 mg, 100 capsule bottles, sold under two labels: (1) Mallinckrodt / Tyco Healthcare brand, with NDC #0406-4357-01, UPC 3 0406 4357 019. (2) UAD brand under the product name: LORCET -HD, with NDC #0785-1120-01, UPC 3 07851 12001 8, Recall # D-385-5.
CODE
1) Lot #s 4357D06966, 4357D06967, 4357D11149, 4357D11150,
4357E06904, 4357E13927, 4357E15890, 4357H00966, 4357H00665, 4357H07025, 4357H10604, 4357H11513;
2) Lot #UL0301A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt, Inc, Berkeley, MO, by letters dated June 21, 2005.
Manufacturer: Mallinckrodt, Inc, Hobart, NY. Firm initiated recall is ongoing.
REASON
Failure to comply with good manufacturing practices resulting in inadequate blend validation.
VOLUME OF PRODUCT IN COMMERCE
109,256 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma, Recall # B-1078-5
CODE
Unit numbers: 0530358958, 0530358549, 0530357882, 0530355968, 0530355325, 0530354994
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc, Lexington, KY, by facsimile on February 20, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC
_______________________________
PRODUCT
Recovered Plasma, Recall # B-1169-5
CODE
Unit number: 19GS31636
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Tennessee Valley Region, Nashville, TN, by letter dated May 7, 2004. Firm initiated recall is complete.
REASON
Blood product, processed from a unit of Whole Blood with an elevated ALT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1200-5
CODE
Unit number: 71M52026X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on July 27, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1337-5;
b) Cryoprecipitated AHF, Recall # B-1338-5
CODE
a) and b) Unit number: 27GH23096
RECALLING FIRM/MANUFACTURER
American Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone and letter, dated January 10, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication, Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA and OH
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1393-5
CODE
Unit numbers: J15717, J15728, J15727, R51053
RECALLING FIRM/MANUFACTURER
Coastal Bend Blood Center, Corpus Christi, TX, by facsimile and telephone on March 25, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to units of Platelets that were pooled and possibly contaminated with gram-positive cocci, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1427-5;
b) Platelets, Leukocytes Removed, Irradiated,
Recall # B-1428-5
CODE
a) and b) Unit number: FV07162
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone and letter, dated March 31, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to areas considered endemic for malaria and Leishmania, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
RI
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1467-5
b) Platelets Pheresis, Recall # B-1468-5
CODE
a) Unit numbers: 41FE06940, 41FE21637, 41FY85569, and 41GF49411
b) Unit numbers: 41GP40239 (split unit), 41GP39848 (split unit),
41GP39540 (split unit)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by letter dated July 15, 1998. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
AL
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1469-5
CODE
Unit M15052
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA. by email on July 27, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who previously tested positive by a screening test for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Source Plasma, Recall # B-1470-5
CODE
Unit numbers N65425077, N65454077, G97942077, and G97665077
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Riverside, CA, by facsimile on October 8, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who exhibited signs of potential high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Spain
_______________________________
PRODUCT
Platelets Pheresis, Recall # B-1471-5
CODE
Unit FC38096
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA. by telephone on May 8, 2002. Firm initiated recall is complete.
REASON
Blood product, which did not meet product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-1473-5;
b) Recovered Plasma, Recall # B-1474-5
CODE
a) Unit numbers: LL08365, LL03859, and F82791;
b) Unit numbers: LL03859 and F82791
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by facsimile on January 30, 2002, and by letter dated February 28, 2002. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who indicated to having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA and Switzerland
_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1476-5
CODE
Unit numbers: FC49726 (double unit), FC47052 (double unit) and FC49480
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by letter dated May 25, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1477-5
CODE
Unit number: 182248995
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated April 20, 2001.
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WY
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1480-5
CODE
Unit number: 07FH25139
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Service, Tucson, AZ, by letter dated May 17, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured in accordance with established specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1490-5
b) Red Blood Cells, Leukocytes Reduced Irradiated,
Recall # B-1491-5
CODE
a) Unit number 10186-4086
b) Unit number 10185-9812
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on November 26, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AZ
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1493-5
CODE
Unit number: 1071739
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter on August 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1494-5
CODE
Unit number 1078156
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter on July 13, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
_______________________________
PRODUCT
Recovered Plasma, Recall # B-1495-5
CODE
Unit number 0910281
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by facsimile on April 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
_______________________________
PRODUCT
Recovered Plasma, Recall # B-1496-5
CODE
Unit number: 4120092
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by facsimile on September 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1497-5
CODE
Unit numbers 12794-4584 and 12797-4168
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on September 30, 2003.
Manufacturer: Blood Systems, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NM
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1510-5
b) Recovered Plasma, for manufacturing injectable products,
Recall # B-1511-5
CODE
a) and b) Unit number: 4717068
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK, by facsimiles on March 4, 10, and 23, 2004.
Manufacturing Firm: Oklahoma Blood Institute, Enid, OK. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland
_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1524-5
CODE
Unit numbers: 231506686 (double collection), 231508090
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on February 9 and 13, 2004, or by facsimile dated February 13, 2004.
Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Red Cells, leukoreduced using a defective Pall filter, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MS, MT, WY, and the UK
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
Recall # B-1525-5
b) Fresh Frozen Plasma, Recall # B-1526-5
c) Recovered Plasma, Recall # B-1527-5
CODE
a) Unit numbers: 4497340, 4554526, 4677152,
and 4733975
b) Unit number: 4497340
c) Unit numbers: 4677152, 4733975, and 4497340
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on January 26, January 30, February 17, and March 2, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
MI, TX, OK, FL, CA, and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Recall # 1528-5
b) Red Blood Cells Leukocytes Reduced,
Recall # B-1529-5
c) Recovered Plasma, Recall # B-1530-5
CODE
a) Unit number: GH12354
b) Unit number: GH15801
c) Unit numbers: GH15801, GH12354
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, electronically on December 23, 2003, and by letter, dated January 15, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, Austria, and Switzerland
______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-1531-5
b) Platelets Pheresis, Leukocytes Reduced
Irradiated, Recall # B-1532-5
c) Fresh Frozen Plasma [Apheresis], Recall # 1533-5
CODE
a) Part 1, Unit numbers: 22KG75592, 22KG76626, 22KG67361, 22KG68340, 22KG68100, 22KG67324, 22KG67474, 22KG68436, 22KG69756, 22KG70918, 22KG74004, 22KG71532, 22KG72748, 22KG72852, 22KG73080, 22KG75300, 22KG75470, 22KG67359, 22KG71035, 22KG71043, 22KG73799, 22KG73836, 22KG72584, 22KG72585, 22KG66715, 22KG66716, 22KG66792, 22KG67318, 22KG67322, 22KG67338, 22KG67380, 22KG67420, 22KG67451, 22KG67462, 22KG67508, 22KG67543, 22KG67557, 22KG67566, 22KG68025, 22KG68049, 22KG68071, 22KG68088, 22KG68099, 22KG68104, 22KG68111, 22KG68188, 22KG68190, 22KG68251, 22KG68258, 22KG68348, 22KG68367, 22KG68381, 22KG68425, 22KG68426, 22KG68468, 22KG68519, 22KG68527, 22KG68548, 22KG68638, 22KG68647, 22KG68669, 22KG68677, 22KG68682, 22KG68723, 22KG69611, 22KG69612, 22KG69633, 22KG69652, 22KG69654, 22KG69655, 22KG69671, 22KG69691, 22KG69730, 22KG69757, 22KG69787, 22KG69795, 22KG69806, 22KG69820, 22KG69844, 22KG69846, 22KG69901, 22KG69917, 22KG69922, 22KG69928, 22KG69934, 22KG69936, 22KG69957, 22KG69983, 22KG69988, 22KG69989, 22KG69998, 22KG70871, 22KG70888, 22KG70956, 22KG70976, 22KG70981, 22KG71036, 22KG71051, 22KG71078, 22KG71095, 22KG71128, 22KG71183, 22KG71640, 22KG71688, 22KG71702, 22KG71704, 22KG71840, 22KG71851, 22KG71860, 22KG71873, 22KG71875, 22KG71889, 22KG71907, 22KG71962, 22KG71989, 22KG72022, 22KG72074, 22KG72204, 22KG72220, 22KG72288, 22KG72330, 22KG72377, 22KG72435, 22KG72437, 22KG72457, 22KG72458, 22KG72560, 22KG72644, 22KG72650, 22KG72651, 22KG72652, 22KG72658, 22KG72668, 22KG72696, 22KG72699, 22KG72707, 22KG72708, 22KG72709, 22KG72710, 22KG72745, 22KG72747, 22KG72790, 22KG72834, 22KG72850, 22KG72868, 22KG72870, 22KG72882, 22KG72884, 22KG72890, 22KG72899, 22KG72909, 22KG72911, 22KG72920, 22KG72929, 22KG72947, 22KG73004, 22KG73028, 22KG73076, 22KG73089, 22KG73098, 22KG73146, 22KG73197, 22KG73309, 22KG73315, 22KG73318, 22KG73324, 22KG73377, 22KG73416, 22KG73433, 22KG73441, 22KG73443, 22KG73448, 22KG73597, 22KG73630, 22KG73668, 22KG73711, 22KG73745, 22KG73758, 22KG73775, 22KG73784, 22KG73839, 22KG73880, 22KG74128, 22KG74174, 22KG74180, 22KG74204, 22KG74221, 22KG74314, 22KG74395, 22KG74449, 22KG74463, 22KG74464, 22KG74480, 22KG74493, 22KG74647, 22KG74666, 22KG74694, 22KG74725, 22KG74730, 22KG74738, 22KG74753, 22KG74773, 22KG74891, 22KG74931, 22KG74953, 22KG75042, 22KG75046, 22KG75066, 22KG75091, 22KG75123, 22KG75126, 22KG75127, 22KG75138, 22KG75161, 22KG75178, 22KG75227, 22KG75275, 22KG75277, 22KG75286, 22KG75299, 22KG75343, 22KG75344, 22KG75358, 22KG75368, 22KG75458, 22KG75461, 22KG75473, 22KG75526, 22KG75537, 22KG75538, 22KG75549, 22KG75552, 22KG75607, 22KG76414, 22KG76415, 22KG76491, 22KG76527, 22KG76574, 22KG76593, 22LE00038, 22KG70902, 22KG68406, 22KG69997, 22KG71146, 22KG71619, 22KG71882, 22KG71883, 22KG71908, 22KG71943, 22KG72182, 22KG72355, 22KG72439, 22KG72465, 22KG72493, 22KG72568, 22KG72617, 22KG72630, 22KG72640, 22KG72984, 22KG73000, 22KG73061, 22KG73659, 22KG73935, 22KG74241, 22KG75191, 22KG66786, 22KG67343, 22KG67350, 22KG67388, 22KG67433, 22KG67537, 22KG67596, 22KG68006, 22KG68668, 22KG69613, 22KG69664, 22KG69755, 22KG69879, 22KG69924, 22KG69925, 22KG69935, 22KG69936, 22KG69969, 22KG69976, 22KG69979, 22KG71070, 22KG71108, 22KG71509, 22KG71758, 22KG71881, 22KG71994, 22KG72477, 22KG72669, 22KG72674, 22KG72675, 22KG72746, 22KG72900, 22KG73074, 22KG73245, 22KG74141, 22KG74310, 22KG74544, 22KG74546, 22KG74547, 22KG74617, 22KG74709, 22KG74710, 22KG74726, 22KG74754, 22KG74839, 22KG74850, 22KG74858, 22KG75135, 22KG75142, 22KG75359, 22KG76476, 22KG76492, 22KG76535, 22KG66744, 22KG66764, 22KG66769, 22KG72983, 22KG73572, 22KG73949, 22KG76602, 22KG68227, 22KG73135, 22KG74880, 22KG76625, 22KG67560, 22KG71862, 22KG72933, 22KG73885, 22KG74819, 22KG75228, 22KG68038, 22KG71885, 22KG75622, 22KG68494, 22KG71987, 22KG73523, 22KG74406, 22KG71654, 22KG66797, 22KG66798, 22KG67431, 22KG67434, 22KG67492, 22KG68076, 22KG68089, 22KG68125, 22KG68127, 22KG68128, 22KG68154, 22KG68189, 22KG68206, 22KG68347, 22KG68402, 22KG68558, 22KG68599, 22KG68705, 22KG68706, 22KG68716, 22KG68759, 22KG69627, 22KG69651, 22KG69665, 22KG69741, 22KG69742, 22KG69781, 22KG69818, 22KG69834, 22KG69869, 22KG69951, 22KG69967, 22KG70828, 22KG70838, 22KG70897, 22KG70940, 22KG71062, 22KG71087, 22KG71088, 22KG71093, 22KG71094, 22KG71118, 22KG71126, 22KG71180, 22KG71195, 22KG71656, 22KG71718, 22KG71719, 22KG71753, 22KG71872, 22KG71911, 22KG71937, 22KG72048, 22KG72165, 22KG72311, 22KG72378, 22KG72381, 22KG72592, 22KG72606, 22KG72627, 22KG72753, 22KG72836, 22KG72843, 22KG72869, 22KG72897, 22KG72908, 22KG72942, 22KG72978, 22KG73050, 22KG73056, 22KG73132, 22KG73154, 22KG73163, 22KG73165, 22KG73221, 22KG73250, 22KG73273, 22KG73285, 22KG73286, 22KG73388, 22KG73406, 22KG73417, 22KG73473, 22KG73617, 22KG73627, 22KG73698, 22KG73756, 22KG73760, 22KG73948, 22KG74116, 22KG74492, 22KG74782, 22KG74862, 22KG74887, 22KG75189, 22KG75211, 22KG75560, 22KG75591, 22KG76509, 22KG76539, 22KG76562, 22KG76570, 22KG66707, 22KG66709, 22KG66787, 22KG67313, 22KG67459, 22KG68200, 22KG68329, 22KG68432, 22KG68439, 22KG68440, 22KG68482, 22KG68680, 22KG68796, 22KG69647, 22KG69776, 22KG69830, 22KG69852, 22KG69870, 22KG69890, 22KG69903, 22KG70805, 22KG70982, 22KG70992, 22KG71009, 22KG71023, 22KG71040, 22KG71160, 22KG71163, 22KG71421, 22KG71441, 22KG71476, 22KG71653, 22KG71697, 22KG71942, 22KG72181, 22KG72283, 22KG72587, 22KG72637, 22KG72638, 22KG72660, 22KG72692, 22KG72860, 22KG72921, 22KG72954, 22KG73015, 22KG73069, 22KG73118, 22KG73348, 22KG73387, 22KG73461, 22KG73462, 22KG73495, 22KG73591, 22KG73602, 22KG73708, 22KG73765, 22KG73864, 22KG73876, 22KG73928, 22KG74023, 22KG74139, 22KG74169, 22KG74227, 22KG74244, 22KG74359, 22KG74380, 22KG74418, 22KG74485, 22KG74675, 22KG74708, 22KG74793, 22KG74826, 22KG74834, 22KG74853, 22KG74856, 22KG74870, 22KG74898, 22KG74949, 22KG74952, 22KG74992, 22KG75002, 22KG75034, 22KG75067, 22KG75076, 22KG75108, 22KG75111, 22KG75160, 22KG75218, 22KG75219, 22KG75222, 22KG75287, 22KG75312, 22KG75332, 22KG75340, 22KG75369, 22KG75411, 22KG75437, 22KG75447, 22KG75487, 22KG75509, 22KG75540, 22KG75562, 22KG75593, 22KG75624, 22KG75655, 22KG75673, 22KG76478, 22KG76493, 22KG76510, 22KG76603, 22KG76610, 22KG76614, 22LE01718, 22LE01764, 22KG74770, 22KG76550, 22KG68229, 22KG71498, 22KG71759, 22KG72490, 22KG72586, 22KG72649, 22KG72672, 22KG72686, 22KG72828, 22KG73128, 22KG73284, 22KG73483, 22KG73809, 22KG75482, 22KG76431, 22KG66755, 22KG68151, 22KG69883, 22KG69965, 22KG72820, 22KG73213, 22KG73220, 22KG73230, 22KG74973, 22KG75545, 22KG66755, 22KG68151, 22KG69883, 22KG69965, 22KG72820, 22KG73213, 22KG73220, 22KG73230, 22KG74973, 22KG75545, 22KG66755, 22KG68151, 22KG69883, 22KG69965, 22KG72820, 22KG73213, 22KG73220, 22KG73230, 22KG74973, 22KG75545, 22KG66755, 22KG68151, 22KG69883, 22KG69965, 22KG72820, 22KG73213, 22KG73220, 22KG73230, 22KG74973, 22KG75545, 22KG73689, 22KG73699, 22KG73253, 22KG68286, 22KG68288, 22KG68493, 22KG76003, 22FK97906, 22FK97907, 22FK97912, 22KG66725, 22KG66727, 22KG67383, 22KG67390, 22KG67391, 22KG67469, 22KG67502, 22KG67556, 22KG68226, 22KG68252, 22KG68779, 22KG69707, 22KG69743, 22KG69765, 22KG69882, 22KG69968, 22KG70928, 22KG70961, 22KG70962, 22KG70980, 22KG71120, 22KG71615, 22KG71630, 22KG71631, 22KG71696, 22KG71986, 22KG72456, 22KG72459, 22KG72475, 22KG72569, 22KG72619, 22KG72620, 22KG72665, 22KG72666, 22KG72782, 22KG72798, 22KG73351, 22KG73364, 22KG73690, 22KG73819, 22KG73852, 22KG73879, 22KG74002, 22KG74031, 22KG74050, 22KG74387, 22KG74416, 22KG74476, 22KG74557, 22KG74559, 22KG74627, 22KG74630, 22KG74658, 22KG74696, 22KG74699, 22KG74764, 22KG74875, 22KG74889, 22KG74959, 22KG75004, 22KG75005, 22KG75051, 22KG75124, 22KG75188, 22KG75204, 22KG75262, 22KG75265, 22KG75371, 22KG75434, 22KG75436, 22KG75606, 22KG75614, 22KG75665, 22KG75682, 22KG76004, 22KG76006, 22KG76023, 22KG76027, 22KG76443, 22KG76479, 22KG76611, 22KG76612, 22KG73619, 22KG68207, 22KG68213, 22KG68504, 22KG72466, 22KG73018, 22KG68017, 22KG68620, 22KG68777, 22KG71101, 22KG71150, 22KG71842, 22KG71849, 22KG73482, 22KG74239, 22KG74473, 22KG75424, 22KG66789, 22KG67367, 22KG67370, 22KG67392, 22KG67423, 22KG67460, 22KG67524, 22KG67528, 22KG67544, 22KG67587, 22KG68005, 22KG68009, 22KG68016, 22KG68029, 22KG68040, 22KG68053, 22KG68062, 22KG68069, 22KG68097, 22KG68156, 22KG68166, 22KG68179, 22KG68207, 22KG68212, 22KG68213, 22KG68228, 22KG68240, 22KG68250, 22KG68253, 22KG68259, 22KG68287, 22KG68309, 22KG68337, 22KG68391, 22KG68393, 22KG68485, 22KG68504, 22KG68537, 22KG68538, 22KG68566, 22KG68582, 22KG68641, 22KG68661, 22KG68746, 22KG69601, 22KG69645, 22KG69744, 22KG69775, 22KG69777, 22KG69779, 22KG69814, 22KG69832, 22KG69857, 22KG69860, 22KG69876, 22KG69881, 22KG69966, 22KG70807, 22KG70839, 22KG70859, 22KG70874, 22KG70893, 22KG70994, 22KG70995, 22KG71061, 22KG71063, 22KG71071, 22KG71103, 22KG71136, 22KG71141, 22KG71142, 22KG71144, 22KG71162, 22KG71171, 22KG71172, 22KG71635, 22KG71674, 22KG71676, 22KG71716, 22KG71717, 22KG71738, 22KG71766, 22KG71841, 22KG71845, 22KG71874, 22KG71879, 22KG71921, 22KG71923, 22KG71932, 22KG71973, 22KG71974, 22KG72290, 22KG72327, 22KG72401, 22KG72450, 22KG72464, 22KG72466, 22KG72577, 22KG72628, 22KG72673, 22KG72730, 22KG72744, 22KG72754, 22KG72755, 22KG72756, 22KG72763, 22KG72764, 22KG72765, 22KG72919, 22KG72931, 22KG72953, 22KG73017, 22KG73018, 22KG73086, 22KG73087, 22KG73103, 22KG73136, 22KG73155, 22KG73187, 22KG73204, 22KG73298, 22KG73305, 22KG73319, 22KG73355, 22KG73434, 22KG73455, 22KG73538, 22KG73546, 22KG73547, 22KG73551, 22KG73552, 22KG73579, 22KG73581, 22KG73722, 22KG73749, 22KG73793, 22KG73800, 22KG73803, 22KG73825, 22KG73826, 22KG73858, 22KG73859, 22KG73867, 22KG73925, 22KG73938, 22KG73946, 22KG73953, 22KG73955, 22KG73983, 22KG73984, 22KG73985, 22KG73986, 22KG74020, 22KG74025, 22KG74029, 22KG74038, 22KG74052, 22KG74159, 22KG74172, 22KG74175, 22KG74217, 22KG74234, 22KG74235, 22KG74266, 22KG74287, 22KG74322, 22KG74371, 22KG74388, 22KG74392, 22KG74447, 22KG74474, 22KG74501, 22KG74502, 22KG74503, 22KG74510, 22KG74521, 22KG74657, 22KG74704, 22KG74745, 22KG74857, 22KG74861, 22KG74871, 22KG74907, 22KG74912, 22KG74928, 22KG74970, 22KG74994, 22KG75063, 22KG75064, 22KG75087, 22KG75107, 22KG75125, 22KG75167, 22KG75172, 22KG75179, 22KG75352, 22KG75379, 22KG75387, 22KG75393, 22KG75394, 22KG75398, 22KG75400, 22KG75403, 22KG75409, 22KG75410, 22KG75421, 22KG75422, 22KG75448, 22KG75449, 22KG75451, 22KG75462, 22KG75521, 22KG75568, 22KG75569, 22KG75579, 22KG75582, 22KG75588, 22KG75613, 22KG75616, 22KG75617, 22KG75648, 22KG75649, 22KG75671, 22KG76015, 22KG76401, 22KG76407, 22KG76467, 22KG76471, 22KG76494, 22KG76501, 22KG76504, 22KG76521, 22KG76523, 22KG67512, 22KG68113, 22KG68700, 22KG69673, 22KG69856, 22KG69958, 22KG70840, 22KG71054, 22KG71642, 22KG71657, 22KG71672, 22KG72397, 22KG72561, 22KG72566, 22KG72605, 22KG72690, 22KG72726, 22KG72889, 22KG72910, 22KG73105, 22KG73133, 22KG73252, 22KG73476, 22KG73618, 22KG73648, 22KG73769, 22KG73855, 22KG73887, 22KG73963, 22KG74304, 22KG74340, 22KG74520, 22KG74522, 22KG74707, 22KG74833, 22KG75150, 22KG75210, 22KG75212, 22KG75335, 22KG76571, 22KG76601, 22KG74521, 22KG69709, 22KG71728, 22KG72597, 22KG74950, 22KG75313, 22KG75520, 22FK97907, 22KG67391, 22KG70961, 22KG72619, 22KG74050, 22KG75436, 22KG76006, 22KG69736, 22KG69926, 22KG74251, 22KG74426, 22KG69765, 22FK97906, 22KG72173, 22KG68717, 22KG69783, 22KG71016, 22KG71565, 22KG71707, 22KG72440, 22KG73085, 22KG73452, 22KG74762, 22KG74892 22KG75504, 22KG67410, 22KG68090, 22KG68597, 22KG68693, 22KG68733, 22KG71125, 22KG71609, 22KG71863, 22KG72567, 22KG72799, 22KG72807, 22KG72891, 22KG72973, 22KG73030, 22KG73037, 22KG73040, 22KG73099, 22KG73162, 22KG73222, 22KG73358, 22KG73366, 22KG73402, 22KG73549, 22KG73792, 22KG73865, 22KG74167, 22KG74223, 22KG74248, 22KG74355, 22KG74437, 22KG74453, 22KG74664, 22KG74676, 22KG74744, 22KG74746, 22KG74964, 22KG75074, 22KG75089, 22KG75174, 22KG75249, 22KG75353, 22KG75354, 22KG75424, 22KG75629, 22KG76405, 22KG76409, 22KG76435, 22KG75247, 22KG66668, 22KG70998, 22KG71545, 22KG72581, 22KG73113, 22KG74348, 22KG74835, 22KG72416, 22KG72431, 22KG73966, 22KG74641, 22KG73687, 22KG74146, 22KG76453, 22KG76464, 22KG76465, 22KG68575, 22KG68642, 22KG72725, 22KG73122, 22KG68779, 22KG74387, 22KG71630, 22KG70892, 22KG71037, 22KG71622, 22KG72325, 22KG73039, 22KG75077, 22KG68481, 22KG68783, 22KG73115, 22KG73667, 22KG68708, 22KG72548, 22KG67368, 22KG73199, 22KG74296, 22KG68444, 22KG69843, 22KG71181, 22KG72769, 22KG73502, 22KG74016, 22KG68405, 22KG67593, 22KG68019, 22KG68463, 22KG68577, 22KG69694, 22KG70829, 22KG70900, 22KG70973, 22KG71116, 22KG72550, 22KG72594, 22KG72659, 22KG72880, 22KG72964, 22KG73188, 22KG73338, 22KG73868, 22KG74448, 22KG74481, 22KG74960, 22KG75320, 22KG75459, 22KG75505, 22KG75506, 22KG75516, 22KG75527, 22KG75528, 22KG75642, 22KG76547, 22KG76583, 22KG76592, 22KG68480, 22KG68510, 22KG69731, 22KG72636, 22KG73042, 22KG73410, 22KG75385, 22KG72413, 22KG74005, 22KG74157, 22KG75334, 22KG67469, 22KG69833, 22KG71654, 22KG73064, 22KG74736, 22KG75388, 22KG71654, 22KG73064, 22KG74736, 22KG75388, 22KG68690, 22KG69937, 22KG73524, 22KG71902, 22KG76589, 22KG76591, 22KG71170, 22KG69721, 22KG69861, 22KG72486, 22KG73114, 22KG76536, 22KG67402, 22KG67469, 22KG67481, 22KG67515, 22KG67575, 22KG68596, 22KG68623, 22KG69638, 22KG69786, 22KG69880, 22KG70876, 22KG70943, 22KG70983, 22KG71861, 22KG72057, 22KG72129, 22KG72824, 22KG73824, 22KG73848, 22KG73856, 22KG74265, 22KG74365, 22KG74408, 22KG74421, 22KG74798, 22KG74916, 22KG74937, 22KG74951, 22KG75003, 22KG75044, 22KG75169, 22KG76434, and 22KG76480

Part 2, Unit numbers: 22KG76012, 22KG73459, 22KG73953, 22KG68432, 22KG71413, 22KG75123, 22KG75277, 22KG71672, 22KG75409, 22KG68386, 22KG69694, 22KG72984, 22KG66668, 22KG71861, 22KG71881, 22KG67322, 22KG67346, 22KG67347, 22KG67443, 22KG67469, 22KG67566, 22KG68049, 22KG68099, 22KG68125, 22KG68215, 22KG68348, 22KG68425, 22KG68517, 22KG68548, 22KG68556, 22KG69641, 22KG69683, 22KG69721, 22KG69730, 22KG69757, 22KG69806, 22KG69916, 22KG69922, 22KG69960, 22KG69976, 22KG69989, 22KG70819, 22KG70868, 22KG70899, 22KG70962, 22KG70998, 22KG71015, 22KG71018, 22KG71023, 22KG71120, 22KG71688, 22KG71704, 22KG71705, 22KG71726, 22KG71745, 22KG71840, 22KG71873, 22KG71875, 22KG71901, 22KG71903, 22KG72022, 22KG72334, 22KG72415, 22KG72430, 22KG72450, 22KG72459, 22KG72463, 22KG72587, 22KG72636, 22KG72765, 22KG72774, 22KG72820, 22KG72835, 22KG72836, 22KG72843, 22KG72890, 22KG72997, 22KG73051, 22KG73076, 22KG73164, 22KG73174, 22KG73197, 22KG73317, 22KG73325, 22KG73372, 22KG73374, 22KG73377, 22KG73417, 22KG73441, 22KG73558, 22KG73593, 22KG73617, 22KG73637, 22KG73658, 22KG73667, 22KG73709, 22KG73758, 22KG74053, 22KG74182, 22KG74201, 22KG74204, 22KG74221, 22KG74280, 22KG74310, 22KG74395, 22KG74480, 22KG74482, 22KG74494, 22KG74524, 22KG74533, 22KG74666, 22KG74710, 22KG74800, 22KG74874, 22KG74891, 22KG74898, 22KG75034, 22KG75066, 22KG75098, 22KG75138, 22KG75178, 22KG75197, 22KG75218, 22KG75219, 22KG75227, 22KG75228, 22KG75262, 22KG75285, 22KG75299, 22KG75343, 22KG75425, 22KG75446, 22KG75447, 22KG75459, 22KG75461, 22KG75481, 22KG75515, 22KG75526, 22KG75538, 22KG75540, 22KG75589, 22KG75649, 22KG75674, 22KG76588, 22KG76592, 22KG76603, 22LE00038, 22KG75274, 22KG68402, 22KG69997, 22KG71146, 22KG71609, 22KG71666, 22KG71882, 22KG71943, 22KG72182, 22KG72390, 22KG73358, 22KG73385, 22KG74296, 22KG74663, 22KG76606, 22KG75398, 22KG67350, 22KG67537, 22KG67544, 22KG68053, 22KG68329, 22KG68494, 22KG68630, 22KG68631, 22KG69755, 22KG69936, 22KG70886, 22KG71043, 22KG71193, 22KG71509, 22KG71545, 22KG71615, 22KG71657, 22KG71660, 22KG71702, 22KG71854, 22KG71907, 22KG71911, 22KG72165, 22KG72586, 22KG72910, 22KG72978, 22KG73245, 22KG73248, 22KG73285, 22KG73416, 22KG73286, 22KG73523, 22KG73524, 22KG73619, 22KG73710, 22KG74128, 22KG74365, 22KG74430, 22KG75378, 22KG75421, 22KG75558, 22KG76435, 22KG72763, 22KG67403, 22KG71002, 22KG69785, 22KG72860, 22KG75568, 22KG68771, 22KG67512, 22KG68009, 22KG68076, 22KG68154, 22KG68519, 22KG68759, 22KG69742, 22KG69890, 22KG69891, 22KG70859, 22KG70894, 22KG71109, 22KG71619, 22KG71747, 22KG71753, 22KG71872, 22KG71937, 22KG71973, 22KG71986, 22KG72381, 22KG72483, 22KG72486, 22KG72562, 22KG72592, 22KG72666, 22KG72667, 22KG72669, 22KG72834, 22KG73050, 22KG73074, 22KG73222, 22KG73230, 22KG73591, 22KG73756, 22KG73760, 22KG73867, 22KG74029, 22KG74234, 22KG74235, 22KG74322, 22KG74353, 22KG74428, 22KG74522, 22KG74658, 22KG74781, 22KG74861, 22KG74892, 22KG74981, 22KG74990, 22KG75127, 22KG75189, 22KG75292, 22KG75293, 22KG75411, 22KG75506, 22KG75607, 22KG76546, 22KG76613, 22KG66730, 22KG67313, 22KG67451, 22KG67481, 22KG68069, 22KG68206, 22KG68680, 22KG68705, 22KG68733, 22KG68772, 22KG68779, 22KG69978, 22KG70805, 22KG70857, 22KG70943, 22KG71000, 22KG71036, 22KG71040, 22KG71062, 22KG71095, 22KG71134, 22KG71565, 22KG71629, 22KG71630, 22KG71632, 22KG71635, 22KG71697, 22KG71831, 22KG71942, 22KG72074, 22KG72637, 22KG72638, 22KG72809, 22KG73056, 22KG73118, 22KG73277, 22KG73318, 22KG73348, 22KG73373, 22KG73448, 22KG73461, 22KG73516, 22KG73679, 22KG73720, 22KG73747, 22KG73765, 22KG73876, 22KG73925, 22KG74157, 22KG74188, 22KG74276, 22KG74304, 22KG74359, 22KG74793, 22KG74905, 22KG74916, 22KG74917, 22KG74928, 22KG74961, 22KG74973, 22KG75002, 22KG75017, 22KG75042, 22KG75088, 22KG75190, 22KG75259, 22KG75318, 22KG75340, 22KG75393, 22KG75469, 22KG75524, 22KG75527, 22KG75529, 22KG75616, 22KG76002, 22KG76028, 22KG76401, 22KG76405, 22KG76408, 22KG76414, 22KG76415, 22KG76464, 22KG76527, 22KG76550, 22KG76590, 22LE01764, 22LE01803, 22KG68026, 22KG68029, 22KG68770, 22KG70952, 22KG71932, 22KG74493, 22KG74820, 22KG67410, 22KG68188, 22KG69832, 22KG71874, 22KG72181, 22KG72231, 22KG72437, 22KG72476, 22KG72686, 22KG73220, 22KG73434, 22KG74619, 22KG75301, 22KG76431, 22KG67325, 22KG59754, 22KG67325, 22KG69754, 22KG67325, 22KG69754, 22KG67325, 22KG69745, 22KG69786, 22KG72584, 22KG66800, 22KG73335, 22KG69638, 22KG70865, 22KG70839, 22KG74856, 22KG70973, 22KG73521, 22KG73955, 22KG68114, 22KG68190, 22KG68745, 22KG69882, 22KG69901, 22KG71070, 22KG71716, 22KG71717, 22KG71718, 22KG71885, 22KG71900, 22KG72330, 22KG72620, 22KG72963, 22KG72965, 22KG73103, 22KG73351, 22KG73364, 22KG73455, 22KG73541, 22KG73549, 22KG73647, 22KG73649, 22KG73847, 22KG73852, 22KG73864, 22KG73916, 22KG73952, 22KG74050, 22KG74169, 22KG74421, 22KG74491, 22KG74559, 22KG74676, 22KG74745, 22KG74746, 22KG74875, 22KG75051, 22KG75410, 22KG75549, 22KG75606, 22KG76422, 22KG76560, 22KG76561, 22KG67370, 22KG69602, 22KG73320, 22KG73610, 22KG67358, 22KG68107, 22KG68250, 22KG68253, 22KG68724, 22KG69809, 22KG69903, 22KG69925, 22KG71019, 22KG71071, 22KG71088, 22KG71101, 22KG71653, 22KG71654, 22KG71663, 22KG71727, 22KG71728, 22KG71759, 22KG71760, 22KG71889, 22KG71891, 22KG71951, 22KG72195, 22KG72237, 22KG72327, 22KG72355, 22KG72490, 22KG72493, 22KG72567, 22KG72606, 22KG72672, 22KG72677, 22KG72730, 22KG72762, 22KG72799, 22KG72859, 22KG72899, 22KG73080, 22KG73111, 22KG73133, 22KG73135, 22KG73136, 22KG73146, 22KG73296, 22KG73402, 22KG73435, 22KG73473, 22KG73508, 22KG73817, 22KG73907, 22KG74159, 22KG74180, 22KG74397, 22KG74485, 22KG74792, 22KG74871, 22KG74937, 22KG74939, 22KG75086, 22KG75331, 22KG75334, 22KG75353, 22KG75354, 22KG75420, 22KG75423, 22KG75492, 22KG75591, 22KG75592, 22KG75643, 22KG76003, 22KG76015, 22KG76016, 22KG76038, 22KG76433, 22KG76434, 22KG76479, 22KG76593, 22KG67318, 22KG76402, 22KG67556, 22KG67595, 22KG68227, 22KG68456, 22KG68493, 22KG68493, 22KG68568, 22KG69876, 22KG71149, 22KG72549, 22KG72566, 22KG72714, 22KG72764, 22KG73200, 22KG73319, 22KG73806, 22KG73879, 22KG74139, 22KG74303, 22KG74641, 22KG74701, 22KG74747, 22KG74828, 22KG74842, 22KG75188, 22KG75363, 22KG75371, 22KG75505, 22KG75559, 22KG75560, 22KG68638, 22KG71162, 22KG73293, 22KG73433, 22KG73553, 22KG73719, 22KG74382, 22KG74462, 22KG74436, 22KG75400, 22KG75402, 22KG75685, 22KG75687, 22KG73864, 22KG74746, 22KG71879, 22KG74931, 22KG71716, 22KG74676, 22KG76561, 22KG68151, 22KG71719, 22KG72918, 22KG73114, 22KG74387, 22KG74473, 22KG74952, 22KG75344, 22KG75579, 22FK97904, 22FK97906, 22KG68090, 22KG68226, 22KG68746, 22KG71170, 22KG71674, 22KG71918, 22KG71919, 22KG71923, 22KG72911, 22KG73099, 22KG73212, 22KG73250, 22KG73546, 22KG73547, 22KG73579, 22KG73597, 22KG73628, 22KG73644, 22KG73792, 22KG73914, 22KG73935, 22KG74002, 22KG74004, 22KG74027, 22KG74335, 22KG74416, 22KG74418, 22KG74476, 22KG74512, 22KG74531, 22KG74782, 22KG74901, 22KG75275, 22KG75313, 22KG75433, 22KG75437, 22KG75462, 22KG76614, 22KG72342, 22KG72790, 22KG69695, 22KG72920, 22KG73648, 22KG66786, 22KG72283, 22KG74773, 22KG75504, 22KG74195, 22KG74503, 22KG66769, 22KG69787, 22KG71675, 22KG72909, 22KG73132, 22KG73775, 22KG74834, 22KG68700, 22KG67543, 22KG68504, 22KG68388, 22KG73276, 22KG73294, 22KG74455, 22KG75424, 22KG76501, 22KG76536, 22KG67324, 22KG67505, 22KG67596, 22KG68261, 22KG68481, 22KG68558, 22KG68582, 22KG69852, 22KG69937, 22KG69998, 22KG71093, 22KG71116, 22KG72902, 22KG73700, 22KG74454, 22KG74907, 22KG75403, 22KG75483, 22KG76465, 22KG76500, 22KG76601, 22KG73235, 22KG73645, 22KG67560, 22KG68016, 22KG72748, 22KG69833, 22KG68062, 22KG72748, 22KG72919, 22KG74036, 22KG74548, 22KG74835, 22KG75561, 22KG68062, 22KG72748, 22KG72919, 22KG74036, 22KG74548, 22KG74835, 22KG75561, 22KG68468, 22KG75048, 22KG68408, 22KG72579, 22KG75235, 22KG75005, 22KG66709, 22KG72436, 22KG74174, 22KG67462, 22KG68596, 22KG69934, 22KG69977, 22KG71118, 22KG71622, 22KG71640, 22KG71828, 22KG71962, 22KG71974, 22KG72388, 22KG72431, 22KG72651, 22KG72929, 22KG72952, 22KG73015, 22KG73042, 22KG73124, 22KG73304, 22KG73669, 22KG73975, 22KG74016, 22KG74255, 22KG74373, 22KG74627, 22KG74675, 22KG74724, 22KG74725, 22KG75074, 22KG75091, 22KG75458, 22KG75471, and 22KG76477

Non-standard, Unit numbers: 22KG69785, 22KG71007, 22KG73918, 22KG71187, 22KG72388, 22KG67350, 22KG75333, 22KG74353, 22KG72667, 22KG71188, 22KG72017, 22KG70877, 22KG68386, 22KG73558, 22KG73890, 22KG70831, 22KG70918, 22KG71458, 22KG68229, 22KG70907, and 22KG76425
b) Part 1, Unit numbers: 22KG74716, 22KG75350, 22KG75483, 22KG76002, 22KG74979, 22KG75559, 22KG76568, 22KG76028, 22KG74203, 22KG69902, 22KG73637, 22KG66749, 22KG67442, 22KG67535, 22KG67583, 22KG68417, 22KG68469, 22KG68607, 22KG68757, 22KG68770, 22KG69626, 22KG69684, 22KG69807, 22KG69816, 22KG69845, 22KG69891, 22KG69892, 22KG70972, 22KG70988, 22KG71015, 22KG71052, 22KG71154, 22KG72140, 22KG72438, 22KG72452, 22KG72738, 22KG72996, 22KG73097, 22KG73145, 22KG73186, 22KG73189, 22KG73872, 22KG73964, 22KG74842, 22KG75052, 22KG75053, 22KG75402, 22KG75420, 22KG76520, 22KG76549, 22KG72618, 22KG72720, 22KG72740, 22KG72835, 22KG72962, 22KG73691, 22KG73884, 22KG73895, 22KG74224, 22KG73412, 22KG74494, 22KG74872, 22KG74958, 22KG75086, 22KG75170, 22KG75408, 22KG76025, 22KG76477, 22KG76490, 22KG66774, 22KG68241, 22KG68676, 22KG71034, 22KG72579, 22KG73297, 22KG70908, 22KG75292, 22KG73658, 22KG68681, 22KG71610, 22KG71757, 22KG71985, 22KG72210, 22KG73396, 22KG73740, 22KG73849, 22KG74961, 22KG72430, 22KG72454, 22KG75589, 22KG76581, 22KG69858, 22KG68462, 22KG68771, 22KG75148, 22KG75001, 22KG69641, 22KG70916, 22KG75583, 22KG72610, 22KG75524, 22KG75636, 22KG75524, 22KG75636, 22KG75524, 22KG75636, 22KG75524, 22KG75636, 22KG73726, 22KG74975, 22KG75573, 22KG76606, 22KG69774, 22KG69782, 22KG70894, 22KG70907, 22KG71006, 22KG71132, 22KG72366, 22KG68568, 22KG68509, 22KG74196, 22KG71854, 22KG72476, 22KG72713, 22KG72881, 22KG72985, 22KG73052, 22KG73151, 22KG73240, 22KG73601, 22KG73688, 22KG73751, 22KG73818, 22KG75457, 22KG75492, 22KG76444, 22KG76563, 22KG76564, 22KG71607, 22KG71735, 22KG73516, 22KG75561, 22KG76012, 22KG76447, 22KG68275, 22KG68497, 22KG68761, 22KG68785, 22KG69640, 22KG72787, 22KG67346, 22KG68060, 22KG68114, 22KG68546, 22KG69662, 22KG71197, 22KG72480, 22KG72855, 22KG72963, 22KG73152, 22KG73628, 22KG73847, 22KG74417, 22KG74531, 22KG74533, 22KG75351, 22KG75481, 22KG71143, 22KG75235, 22KG72952, 22KG73235, 22KG74195, 22KG68317, 22KG72879, 22KG73029, 22KG73562, 22KG73727, 22KG74132, 22KG74500, 22KG74555, 22KG74747, 22KG74896, 22KG74939, 22KG75022, 22KG75551, 22KG75643, 22KG76425, 22KG76538, 22KG76638, 22LEO1803, 22KG71938, 22KG73038, 22KG73593, 22KG73908, 22KG73914, 22KG74053, 22KG74428, 22KG74499, 22KG74563, 22KG74565, 22KG74717, 22KG74791, 22KG75196, 22KG75197, 22KG75357, 22KG75363, 22KG75377, 22KG75515, 22KG75517, 22KG76014, 22KG76456, 22KG76588, 22KG76628, 22KG68261, 22KG69674, 22KG71850, 22KG71898, 22KG72859, 22KG72918, 22KG69915, 22KG72995, 22KG68675, 22KG69695, 22KG71002, 22KG71102, 22KG71179, 22KG72299, 22KG73277, 22KG73320, 22KG73610, 22KG73646, 22KG68789, 22KG68272, 22KG68598, 22KG68389, 22KG68724, 22KG68752, 22KG73681, 22KG67542, 22KG68297, 22KG68350, 22KG68415, 22KG69720, 22KG69784, 22KG71133, 22KG71134, 22KG71641, 22KG71901, 22KG72312, 22KG72329, 22KG72415, 22KG72536, 22KG72602, 22KG72629, 22KG73501, 22KG73972, 22KG74037, 22KG74184, 22KG74619, 22KG74649, 22KG75423, 22KG75158, 22KG71623, 22KG71623, 22KG75486, 22KG76630, 22KG75236, 22KG71675, 22KG72436, 22FK97904, 22KG66665, 22KG67412, 22KG67480, 22KG67505, 22KG68077, 22KG68080, 22KG68139, 22KG68141, 22KG68142, 22KG68187, 22KG68290, 22KG68362, 22KG68477, 22KG69681, 22KG69722, 22KG69760, 22KG69794, 22KG69797, 22KG69842, 22KG69948, 22KG69949, 22KG69990, 22KG70964, 22KG70996, 22KG71014, 22KG71022, 22KG71024, 22KG71045, 22KG71046, 22KG71107, 22KG71124, 22KG71149, 22KG71193, 22KG71644, 22KG71747, 22KG71829, 22KG71859, 22KG71892, 22KG71918, 22KG71919, 22KG71920, 22KG71926, 22KG71927, 22KG71928, 22KG71929, 22KG71951, 22KG71953, 22KG71963, 22KG72147, 22KG72402, 22KG72403, 22KG72496, 22KG72545, 22KG72608, 22KG72609, 22KG72639, 22KG72677, 22KG72683, 22KG72698, 22KG72700, 22KG72719, 22KG72733, 22KG72781, 22KG72829, 22KG72833, 22KG72845, 22KG72858, 22KG72867, 22KG72898, 22KG72907, 22KG72955, 22KG72972, 22KG73011, 22KG73035, 22KG73111, 22KG73124, 22KG73153, 22KG73192, 22KG73201, 22KG73212, 22KG73227, 22KG73248, 22KG73293, 22KG73300, 22KG73303, 22KG73304, 22KG73333, 22KG73335, 22KG73353, 22KG73372, 22KG73376, 22KG73426, 22KG73435, 22KG73451, 22KG73470, 22KG73489, 22KG73494, 22KG73496, 22KG73500, 22KG73508, 22KG73525, 22KG73588, 22KG73656, 22KG73657, 22KG73672, 22KG73679, 22KG73717, 22KG73741, 22KG73747, 22KG73757, 22KG73791, 22KG73807, 22KG73808, 22KG73817, 22KG73835, 22KG73846, 22KG73877, 22KG73905, 22KG73907, 22KG73909, 22KG73931, 22KG73945, 22KG73954, 22KG73962, 22KG74027, 22KG74036, 22KG74040, 22KG74049, 22KG74056, 22KG74113, 22KG74145, 22KG74182, 22KG74187, 22KG74201, 22KG74222, 22KG74258, 22KG74337, 22KG74378, 22KG74382, 22KG74397, 22KG74436, 22KG74439, 22KG74457, 22KG74513, 22KG74524, 22KG74534, 22KG74545, 22KG74628, 22KG74665, 22KG74673, 22KG74687, 22KG74706, 22KG74732, 22KG74739, 22KG74752, 22KG74771, 22KG74792, 22KG74866, 22KG74878, 22KG74895, 22KG74904, 22KG74965, 22KG74987, 22KG75001, 22KG75065, 22KG75078, 22KG75157, 22KG75159, 22KG75175, 22KG75194, 22KG75225, 22KG75259, 22KG75285, 22KG75389, 22KG75433, 22KG75435, 22KG75471, 22KG76422, 22KG76423, 22KG76442, 22KG76455, 22KG76466, 22KG76498, 22KG76537, 22KG76546, 22KG76565, 22KG76580, 22KG76613, and 22KG76627

Part 2, Unit numbers 22KG74716, 22KG75673, 22KG74695, 22KG67420, 22KG68381, 22KG68641, 22KG69672, 22KG69674, 22KG69777, 22KG69904, 22KG70877, 22KG71179, 22KG71183, 22KG72140, 22KG72891, 22KG73085, 22KG73086, 22KG73105, 22KG73187, 22KG73837, 22KG73838, 22KG73840, 22KG74005, 22KG74141, 22KG74499, 22KG74649, 22KG73113, 22KG73966, 22KG74513, 22KG67465, 22KG68088, 22KG68241, 22KG68497, 22KG68663, 22KG67524, 22KG69633, 22KG75332, 22KG71852, 22KG72630, 22KG72649, 22KG73462, 22KG72290, 22KG75582, 22KG69720, 22KG69729, 22KG74502, 22KG69693, 22KG73887, 22KG73489, 22KG74186, 22KG75449, 22KG76626, 22KG72682, 22KG72691, 22KG73272, 22KG68040, 22KG71908, 22KG72608, 22KG73029, 22KG75158, 22KG76457, 22KG76568, 22KG71498, 22KG71498, 22KG71498, 22KG71498, 22KG69782, 22KG69830, 22KG73468, 22KG72798, 22KG75640, 22KG67485, 22KG72434, 22KG72715, 22KG72897, 22KG73151, 22KG73240, 22KG73740, 22KG76453, 22KG69889, 22KG69969, 22KG73305, 22KG76446, 22KG76535, 22KG76564, 22KG69783, 22KG68274, 22KG68276, 22KG69744, 22KG70828, 22KG71007, 22KG72456, 22KG73028, 22KG74657, 22KG74707, 22KG74708, 22KG70871, 22KG72831, 22KG75097, 22KG76580, 22KG71610, 22KG72753, 22KG73584, 22KG73846, 22KG74722, 22KG69760, 22KG70972, 22KG72173, 22KG72833, 22KG74555, 22KG74896, 22KG75588, 22KG72973, 22KG73037, 22KG73122, 22KG73123, 22KG73162, 22KG73163, 22KG73213, 22KG73507, 22KG73820, 22KG73868, 22KG74172, 22KG74175, 22KG74665, 22KG74883, 22KG74970, 22KG75124, 22KG75494, 22KG71171, 22KG74902, 22KG72943, 22KG72429, 22KG72745, 22KG73278, 22KG72404, 22KG72829, 22KG73646, 22KG68391, 22KG68761, 22KG69645, 22KG69719, 22KG68272, 22KG68389, 22KG69613, 22KG76636, 22KG69626, 22KG69684, 22KG69776, 22KG70818, 22KG71136, 22KG71195, 22KG72438, 22KG72537, 22KG72629, 22KG72962, 22KG73708, 22KG74501, 22KG74629, 22KG74726, 22KG75194, 22KG75204, 22KG76539, 22KG76547, 22KG74791, 22KG70981, 22KG74116, 22KG66736, 22KG68127, 22KG68156, 22KG68203, 22KG68204, 22KG68213, 22KG68317, 22KG68682, 22KG68717, 22KG69818, 22KG69913, 22KG70995, 22KG71102, 22KG71151, 22KG71172, 22KG71197, 22KG71607, 22KG71620, 22KG71621, 22KG71661, 22KG71673, 22KG71757, 22KG71842, 22KG71927, 22KG71953, 22KG71998, 22KG72325, 22KG72413, 22KG72416, 22KG72496, 22KG72665, 22KG72673, 22KG72700, 22KG72719, 22KG72733, 22KG72822, 22KG72828, 22KG72845, 22KG72850, 22KG72852, 22KG72867, 22KG72964, 22KG73035, 22KG73182, 22KG73192, 22KG73204, 22KG73227, 22KG73500, 22KG73525, 22KG73538, 22KG73568, 22KG73687, 22KG73689, 22KG73722, 22KG73752, 22KG73757, 22KG73773, 22KG73774, 22KG73807, 22KG73808, 22KG73821, 22KG73835, 22KG73836, 22KG73877, 22KG73909, 22KG74049, 22KG74187, 22KG74248, 22KG74258, 22KG74388, 22KG74392, 22KG74457, 22KG74474, 22KG74490, 22KG74673, 22KG74739, 22KG74853, 22KG74878, 22KG74895, 22KG74965, 22KG74994, 22KG75004, 22KG75078, 22KG75147, 22KG75175, 22KG75193, 22KG75389, 22KG75394, 22KG75482, 22KG75487, 22KG75521, 22KG75545, 22KG75552, 22KG75553, 22KG75613, 22KG75617, 22KG75629, 22KG75656, 22KG75665, 22KG76006, 22KG76025, 22KG76409, 22KG76466, 22KG76489, 22KG76496, 22KG76521, 22KG76571, 22KG76611, and 22KG76612

c) Unit numbers 22KG71199, 22KG69580, 22KG71649, 22KG71642, 22KG71625, 22KG71197, 22KG71194, 22KG71193, 22KG71169, 22KG71049, 22KG70966, 22KG69984, 22KG69967, 22KG71641, 22KG71119, 22KG71105, 22KG71142, 22KG71137, 22KG71136, 22KG71134, 22KG69886, 22KG69987, 22KG71135, 22KG69985, 22KG69966, 22KG69948, 22KG69928, 22KG71059, 22KG73611, 22KG72717, 22KG72624, 22KG71923, 22KG72693, 22KG75124, 22KG74873, 22KG74883, 22KG75003, 22KG75054, 22KG75072, 22KG76410, 22KG75113, 22KG75136, 22KG75236, 22KG74968, 22KG74798, 22KG75102, 22KG72795, 22KG74028, 22KG72580, 22KG72640, 22KG72655, 22KG72783, 22KG72863, 22KG72866, 22KG75036, 22KG73229, 22KG71957, 22KG73795, 22KG73876, 22KG73927, 22KG72779, 22KG72449, 22KG68638, 22KG72434, 22KG68641, 22KG72440, 22KG72452, 22KG68680, 22KG68789, 22KG71071, 22KG70906, 22KG71620, 22KG69819, 22KG71747, 22KG72435, 22KG72486, 22KG66709, 22KG71069, 22FK97906, 22KG68787, 22KG69677, 22KG69830, 22KG70848, 22KG70962, 22KG70997, 22KG71037, 22KG72719, 22KG72806, 22KG72945, 22KG73278, 22KG73320, 22KG73355, 22KG73359, 22KG73627, 22KG73629, 22KG73630, 22KG73637, 22KG73639, 22KG73644, 22KG68799, 22KG68490, 22KG69759, 22KG73633, 22KG73634, 22KG73640, 22KG73642, 22KG73363, 22KG72872, 22KG72951, 22KG72966, 22KG72980, 22KG72999, 22KG71801, 22KG71809, 22KG72280, 22KG72520, 22KG72521, 22KG72522, 22KG72542, 22KG76548, 22KG72546, 22KG72523, 22KG71839, 22KG71837, 22KG71823, 22KG71739, 22KG73870, 22KG74473, 22KG74436, 22KG73899, 22KG73896, 22KG73872, 22KG73849, 22KG73882, 22KG74862, 22KG74666, 22KG74869, 22KG74597, 22KG74605, 22KG74863, 22KG73975, 22KG74544, 22KG71937, 22KG72334, 22KG72697, 22KG72699, 22KG72855, 22KG73000, 22KG73270, 22KG72705, 22KG73830, 22KG73615, 22KG73604, 22KG72818, 22KG72797, 22KG72706, 22KG72696, 22KG72798, 22KG72888, 22KG72928, 22KG73607, 22FK97907, 22KG72740, 22KG73277, 22KG73668, 22KG73691, 22KG73741, 22KG75088, 22KG73713, 22KG72855, 22KG69672, 22KG69845, 22KG71676, 22KG69901, 22KG71653, 22KG70908, 22KG71080, 22KG71078, 22KG71654, 22KG68663, 22KG72402, 22KG68566, 22KG68537, 22KG68529, 22KG71101, 22KG69969, 22KG69977, 22KG71190, 22KG71629, 22KG71631, 22KG71116, 22KG71132, 22KG71106, 22KG71146, 22KG71046, 22KG71021, 22KG69922, 22KG70819, 22KG70853, 22KG70864, 22KG70911, 22KG70960, 22KG71139, 22KG71093, 22KG68489, 22KG71077, 22KG71086, 22KG69917, 22KG70996, 22KG68701, 22KG69817, 22KG68648, 22KG66738, 22KG68360, 22KG68432, 22KG68580, 22KG68714, 22KG68759, 22KG68773, 22KG69619, 22KG69628, 22KG69753, 22KG68439, 22KG68529, 22KG68566, 22KG68648, 22KG69672, 22KG69845, 22KG69922, 22KG71021, 22KG71078, 22KG71093, 22KG71103, 22KG71124, 22KG71190, 22KG71653, 22KG71676, 22KG74917, 22KG74840, 22KG74907, 22KG74900, 22KG74894, 22KG74890, 22KG74889, 22KG74864, 22KG74943, 22KG72713, 22KG73874, 22KG71939, 22KG71966, 22KG71990, 22KG72585, 22KG72621, 22KG72634, 22KG72641, 22KG72685, 22KG72715, 22KG72731, 22KG72858, 22KG72861, 22KG72983, 22KG73850, 22KG72666, 22KG73864, 22KG73190, 22KG73831, 22KG73694, 22KG73688, 22KG75098, 22KG75100, 22KG73468, 22KG74837, 22KG74834, 22KG74733, 22KG74715, 22KG74711, 22KG74707, 22KG74705, 22KG74937, 22KG74693, 22KG74611, 22KG74201, 22KG74157, 22KG74838, 22KG74003, 22KG74915, 22KG73934, 22KG75127, 22KG74945, 22KG74918, 22KG73654, 22KG73601, 22KG73591, 22KG73566, 22KG73549, 22KG73395, 22KG73218, 22KG73204, 22KG73869, 22KG75034, 22KG74817, 22KG74819, 22KG74833, 22KG74881, 22KG74887, 22KG74892, 22KG74906, 22KG74979, 22KG74815, 22KG75059, 22KG73408, 22KG74909, 22KG72669, 22KG74685, 22KG73116, 22KG73126, 22KG73699, 22KG73756, 22KG73764, 22KG73796, 22KG74167, 22KG74434, 22KG74636, 22KG74673, 22KG74060, 22KG74558, 22KG74514, 22KG74484, 22KG74563, 22KG74032, 22KG74027, 22KG73987, 22KG73984, 22KG73985, 22KG73216, 22KG73468, 22KG73591, 22KG73864, 22KG73934, 22KG74060, 22KG74201, 22KG74494, 22KG74673, 22KG74695, 22KG74706, 22KG74834, 22KG74889, 22KG74907, 22KG74916, 22KG75098, 22KG70896, 22KG70915, 22KG68722, 22KG68745, 22KG68636, 22KG68596, 22KG68546, 22KG66852, 22KG71003, 22KG68695, 22KG70951, 22KG71176, 22KG70926, 22KG70912, 22KG69913, 22KG66740, 22KG69611, 22KG70881, 22KG68596, 22KG76428, 22KG76427, 22KG75086, 22KG75174, 22KG75128, 22KG76424, 22KG73297, 22KG72600, 22KG74697, 22KG73911, 22KG72738, 22KG72852, 22KG71867, 22KG66725, 22KG68415, 22KG66686, 22KG66718, 22KG66715, 22KG66789, 22KG69957, 22KG69755, 22KG71181, 22KG69756, 22KG69959, 22KG68517, 22KG71143, 22KG71172, 22KG69769, 22KG71016, 22KG71001, 22KG70972, 22KG68486, 22KG68477, 22KG69809, 22KG70999, 22KG71000, 22KG69952, 22KG69981, 22KG71200, 22KG71636, 22KG71640, 22KG71188, 22KG71045, 22KG71066, 22KG71161, 22KG71159, 22KG71635, 22KG71171, 22KG71180, 22KG71187, 22KG70903, 22KG71611, 22KG71619, 22KG68660, 22KG71183, 22KG68485, 22KG68709, 22KG66710, 22KG66735, 22KG66800, 22KG69990, 22KG66108, 22KG68704, 22KG66711, 22KG68738, 22KG68765, 22KG68793, 22KG69697, 22KG68104, 22KG70918, 22KG71128, 22KG71122, 22KG70870, 22KG69988, 22KG70982, 22KG71044, 22KG74005, 22KG73920, 22KG73907, 22KG73929, 22KG73935, 22KG73937, 22KG73940, 22KG74002, 22KG74011, 22KG74420, 22KG74484, 22KG73902, 22KG73941, 22KG73692, 22KG73928, 22KG73113, 22KG73121, 22KG73161, 22KG73516, 22KG73594, 22KG73772, 22KG73800, 22KG73830, 22KG73851, 22KG73863, 22KG73900, 22KG73898, 22KG73186, 22KG75406, 22KG74986, 22KG76425, 22KG76422, 22KG75409, 22KG73817, 22KG73167, 22KG73719, 22KG73495, 22KG73938, 22KG75412, 22KG73182, 22KG73987, 22KG73986, 22KG73964, 22KG73963, 22KG73955, 22KG73809, 22KG73163, 22KG73133, 22KG73952, 22KG68477, 22KG69755, 22KG69957, 22KG69990, 22KG70999, 22KG71001, 22KG71045, 22KG71068, 22KG71143, 22KG71151, 22KG71172, 22KG71181, 22KG71187, 22KG71635, 22KG73163, 22KG73186, 22KG73516, 22KG73772, 22KG73817, 22KG73935, 22KG73955, 22KG73964, 22KG73966, 22KG74005, 22KG75408, 22KG76422, 22KG76426, 22KG68485, 22KG68517, 22KG69756, 22KG69959, 22KG70903, 22KG70972, 22KG66716, 22KG68674, 22KG69902, 22KG73507, 22KG73647, 22KG74380, 22KG75109, 22KG75301, 22KG68700, 22KG68757, 22KG68777, 22KG70973, 22KG70988, 22KG71002, 22KG74545, 22KG74959, 22KG74963, 22KG74964, 22KG74966, 22KG74984, 22KG75446, 22KG70844, 22KG69606, 22KG70813, 22KG69758, 22KG74882, 22KG73921, 22KG74013, 22KG73901, 22KG68705, 22KG71644, 22KG71697, 22KG72438, 22KG72594, 22KG72675, 22KG72679, 22KG73953, 22KG73971, 22KG73986, 22KG73992, 22KG73994, 22KG74020, 22KG74031, 22KG74531, 22KG74555, 22KG74835, 22KG74860, 22KG75195, 22KG75196, 22KG75378, 22KG75380, 22KG74831, 22KG74671, 22KG74603, 22KG74867, 22KG73968, 22KG73959, 22KG73956, 22KG74540, 22KG74577, 22KG74542, 22KG74550, 22KG74665, 22KG74573, 22KG74601, 22KG74802, 22KG76403, 22KG73990, 22KG72653, 22KG73998, 22KG72622, 22KG73746, 22KG73958, 22KG73988, 22KG73957, 22KG71757, 22KG71845, 22KG72480, 22KG72550, 22KG73593, 22KG73905, 22KG73912, 22KG74016, 22KG74174, 22KG74480, 22KG74616, 22KG71827, 22KG72556, 22KG72540, 22KG72539, 22KG71846, 22KG74684, 22KG74772, 22KG74782, 22KG74970, 22KG74975, 22KG75001, 22KG75041, 22KG75028, 22KG75012, 22KG74996, 22KG74778, 22KG75240, 22KG75057, 22KG68340, 22KG68356, 22KG68445, 22KG68575, 22KG68582, 22KG68717, 22KG68754, 22KG68797, 22KG69662, 22KG69695, 22KG69774, 22KG69781, 22KG69783, 22KG69842, 22KG69857, 22KG69861, 22KG69880, 22KG70874, 22KG70894, 22KG70995, 22KG70998, 22KG71015, 22KG71023, 22KG71034, 22KG71036, 22KG71873, 22KG72330, 22KG72639, 22KG72738, 22KG72754, 22KG72781, 22KG72984, 22KG73358, 22KG73909, 22KG74015, 22KG66792, 22KG71050, 22KG70955, 22KG70969, 22KG70970, 22KG71020, 22KG71030, 22KG71041, 22KG71098, 22KG71082, 22KG70872, 22KG71039, 22KG66772, 22KG70869, 22KG66733, 22KG68590, 22KG68713, 22KG69634, 22KG69822, 22KG69827, 22KG69864, 22KG68573, 22KG70913, 22KG69679, 22KG70971, 22KG70910, 22KG70967, 22KG69666, 22KG68365, 22KG68536, 22KG69643, 22KG68737, 22KG68741, 22KG66717, 22KG58307, 22KG69772, 22KG69629, 22KG68671, 22KG68344, 22KG68447, 22KG73225, 22KG72681, 22KG72678, 22KG72794, 22KG73823, 22KG73233, 22KG72801, 22KG72721, 22KG72576, 22KG71876, 22KG72937, 22KG72495, 22KG72547, 22KG72541, 22KG72248, 22KG72232, 22KG72509, 22KG71882, 22KG71891, 22KG71919, 22KG71953, 22KG71984, 22KG72620, 22KG72637, 22KG72667, 22KG72674, 22KG72690, 22KG72691, 22KG72789, 22KG72829, 22KG72884, 22KG73097, 22KG73098, 22KG73206, 22KG73235, 22KG73276, 22KG73316, 22KG73325, 22KG73416, 22KG73597, 22KG73857, 22KG73880, 22KG73913, 22KG73916, 22KG73931, 22KG74004, 22KG74098, 22KG74449, 22KG74491, 22KG74814, 22KG74902, 22KG74912, 22KG74931, 22KG75024, 22KG75033, 22KG75193, 22KG75506, 22KG75524, 22KG76509, 22KG76510, 22KG76520, 22KG76521, 22KG76546, 22KG76552, 22KG73613, 22KG73833, 22KG73933, 22KG73980, 22KG73612, 22KG74504, 22KG73829, 22KG74911, 22KG74491, 22KG72532, 22KG71865, 22KG73600, 22KG72749, 22KG72815, 22KG72925, 22KG73330, 22KG72922, 22KG73256, 22KG72704, 22KG72792, 22KG73206, 22KG71930, 22KG72923, 22KG71931, 22KG71949, 22KG71991, 22KG72623, 22KG74551, 22KG68476, 22KG70923, 22KG70824, 22KG70927, 22KG68683, 22KG68451, 22KG68420, 22KG68419, 22KG72295, 22KG72558, 22KG72538, 22KG71848, 22KG71820, 22KG74925, 22KG74884, 22KG73712, 22KG72832, 22KG72688, 22KG75498, 22KG76660, 22KG73826, 22KG73835, 22KG73877, 22KG73895, 22KG74426, 22KG73563, 22KG73846, 22KG69951, 22KG69976, 22KG69978, 22KG71120, 22KG74421, 22KG71074, 22KG71121, 22KG71145, 22KG69972, 22KG71157, 22KG69956, 22KG70964, 22KG71746, 22KG71753, 22KG71816, 22KG72237, 22KG72283, 22KG72459, 22KG72475, 22KG72476, 22KG72543, 22KG72551, 22KG68463, 22KG68771, 22KG68772, 22KG69776, 22KG69787, 22KG69882, 22KG71817, 22KG71828, 22KG72536, 22KG72537, 22KG72544, 22KG72545, 22KG72682, 22KG72807, 22KG73230, 22KG73241, 22KG73687, 22KG74874, 22KG74875, 22KG76560, 22KG72963, 22KG73029, 22KG73648, 22KG73672, 22KG75096, 22KG75097, 22KG75099, 22KG75142, 22KG72963, 22KG73029, 22KG73648, 22KG73672, 22KG75096, 22KG75097, 22KG75099, 22KG75142, 22KG72963, 22KG73029, 22KG73648, 22KG73672, 22KG75096, 22KG75097, 22KG75099, 22KG75142, 22KG72963, 22KG73029, 22KG73648, 22KG73672, 22KG75096, 22KG75097, 22KG75099, 22KG75142, 22KG73673, 22KG73692, 22KG73671, 22KG73652, 22KG73632, 22KG73032, 22KG73031, 22KG72988, 22KG72993, 22KG75132, 22KG75314, 22KG75096, 22KG71736, 22KG71738, 22KG71763, 22KG72231, 22KG72477, 22KG72490, 22KG72491, 22KG72496, 22KG72501, 22KG72460, 22KG71772, 22KG71768, 22KG71767, 22KG71773, 22KG72421, 22KG72429, 22KG72403, 22KG71717, 22KG72404, 22KG71716, 22KG71718, 22KG71688, 22KG71672, 22KG71657, 22KG72439, 22KG71657, 22KG72403, 22KG72439, 22KG72530, 22KG73962, 22KG74812, 22KG74813, 22KG74828, 22KG74839, 22KG74841, 22KG74857, 22KG75022, 22KG75051, 22KG75053, 22KG75108, 22KG75111, 22KG75259, 22KG75447, 22KG76432, 22KG76433, 22KG74844, 22KG74823, 22KG74549, 22KG74102, 22KG73969, 22KG74832, 22KG75120, 22KG75184, 22KG75185, 22KG75428, 22KG75114, 22KG72571, 22KG75029, 22KG75467, 22KG76459, 22KG76473, 22KG72777, 22KG73284, 22KG73751, 22KG75109, 22KG75175, 22KG75351, 22KG75360, 22KG75110, 22KG75116, 22KG75122, 22KG72995, 22KG73200, 22KG73819, 22KG75087, 22KG75382, 22KG71927, 22KG71951, 22KG71994, 22KG72618, 22KG72619, 22KG73806, 22KG74865, 22KG76401, 22KG72000, 22KG72404, 22KG75200, 22KG72735, 22KG72780, 22KG74576, 22KG74877, 22KG74891, 22KG74929, 22KG74930, 22KG74967, 22KG75421, 22KG75423, 22KG76431, 22KG76442, 22KG73996, 22KG72741, 22KG71926, 22KG71938, 22KG72390, 22KG72525, 22KG72568, 22KG72602, 22KG72650, 22KG72722, 22KG72725, 22KG72907, 22KG72997, 22KG73051, 22KG73114, 22KG73122, 22KG73135, 22KG73162, 22KG73171, 22KG73196, 22KG73272, 22KG73303, 22KG73309, 22KG73562, 22KG73608, 22KG73665, 22KG73690, 22KG73757, 22KG73765, 22KG73773, 22KG73775, 22KG73848, 22KG73855, 22KG73856, 22KG73858, 22KG74340, 22KG74435, 22KG74453, 22KG74628, 22KG74795, 22KG74866, 22KG75002, 22KG75046, 22KG75067, 22KG75112, 22KG75123, 22KG75137, 22KG75169, 22KG75176, 22KG75179, 22KG75204, 22KG75226, 22KG75302, 22KG75352, 22KG75359, 22KG75387, 22KG75425, 22KG76407, 22KG76409, 22KG76434, 22KG76435, 22KG76447, 22KG73661, 22KG73761, 22KG73762, 22KG73770, 22KG73779, 22KG73771, 22KG72796, 22KG73664, 22KG73142, 22KG72915, 22KG73127, 22KG73108, 22KG73117, 22KG72656, 22KG74456, 22KG74993, 22KG71886, 22KG73883, 22KG74999, 22KG75011, 22KG75037, 22KG75039, 22KG75040, 22KG75232, 22KG71802, 22KG71969, 22KG71868, 22KG71877, 22KG71893, 22KG72554, 22KG72555, 22KG72570, 22KG72572, 22KG72598, 22KG75106, 22KG75009, 22KG74914, 22KG76411, 22KG74998, 22KG73456, 22KG74868, 22KG73043, 22KG73045, 22KG73701, 22KG74000, 22KG73706, 22KG74030, 22KG73997, 22KG73814, 22KG73715, 22KG73707, 22KG75181, 22KG75144, 22KG75187, 22KG75182, 22KG75364, 22KG76440, 22KG75141, 22KG72571, 22FK97914, 22KG72687, 22KG75140, 22KG73301, 22KG73660, 22KG75105, 22KG75131, 22KG73205, 22KG73318, 22KG73508, 22KG73710, 22KG73791, 22KG73793, 22KG71940, 22KG72751, 22KG71959, 22KG73797, 22KG73812, 22KG73048, 22KG73670, 22KG73205, 22KG73705, 22KG71766, 22KG71862, 22KG72342, 22KG72349, 22KG72566, 22KG72567, 22KG72584, 22KG72586, 22KG72589, 22KG72606, 22KG72649, 22KG72684, 22KG72700, 22KG72756, 22KG72782, 22KG72828, 22KG73007, 22KG73037, 22KG73050, 22KG73078, 22KG73105, 22KG73106, 22KG73123, 22KG73231, 22KG73317, 22KG73435, 22KG73461, 22KG73659, 22KG73700, 22KG73749, 22KG73752, 22KG73827, 22KG73954, 22KG74639, 22KG74820, 22KG74825, 22KG74842, 22KG74856, 22KG74858, 22KG74870, 22KG74886, 22KG74973, 22KG74990, 22KG74992, 22KG75042, 22KG75064, 22KG75065, 22KG75091, 22KG75135, 22KG75159, 22KG75178, 22KG75188, 22KG75457, 22KG75459, 22KG75503, 22KG75516, 22KG75552, 22KG76464, 22KG76466, 22KG76493, 22KG76568, 22KG69852, 22KG69965, 22KG70956, 22KG71088, 22KG71125, 22KG71126, 22KG72262, 22KG72265, 22KG72381, 22KG72519, 22KG72728, 22KG72744, 22KG72745, 22KG72746, 22KG73222, 22KG73253, 22KG73452, 22KG73656, 22KG73708, 22KG73722, 22KG73726, 22KG73747, 22KG73066, 22KG73081, 22KG73721, 22KG73732, 22KG73109, 22KG73065, 22KG73059, 22KG72752, 22KG72785, 22KG72883, 22KG73058, 22KG72528, 22KG68337, 22KG68470, 22KG68630, 22KG68631, 22KG68690, 22KG68693, 22KG68706, 22KG72819, 22KG73698, 22KG73774, 22KG74304, 22KG74397, 22KG75044, 22KG75161, 22KG75189, 22KG75319, 22KG75320, 22KG75371, 22KG75389, 22KG75451, 22KG75606, 22KG76405, 22KG76406, 22KG76408, 22KG76500, 22KG76501, 22KG76502, 22KG76504, 22KG76536, 22KG76538, 22KG76539, 22KG66727, 22KG66749, 22KG75319, 22KG75396, 22KG75390, 22KG73693, 22KG75186, 22KG73598, 22KG73777, 22KG75103, 22KG72701, 22KG76507, 22KG76505, 22KG76503, 22KG76463, 22KG75620, 22KG75601, 22KG75455, 22KG75196, 22KG76543, 22KG73662, 22KG68402, 22KG73054, 22KG73635, 22KG73631, 22KG73302, 22KG68444, 22KG68468, 22KG68605, 22KG69626, 22KG69638, 22KG69646, 22KG69766, 22KG69784, 22KG70807, 22KG70840, 22KG70865, 22KG70876, 22KG70893, 22KG70975, 22KG70976, 22KG71019, 22KG66689, 22KG66707, 22KG66730, 22KG66736, 22KG66769, 22KG66787, 22KG66797, 22KG70809, 22KG70850, 22KG70851, 22KG70852, 22KG70883, 22KG70905, 22KG70974, 22KG70978, 22KG71005, 22KG71004, 22KG66719, 22KG69748, 22KG66734, 22KG68422, 22KG68464, 22KG68465, 22KG68805, 22KG68697, 22KG69625, 22KG66692, 22KG72458, 22KG72692, 22KG72771, 22KG73709, 22FK97909, 22KG72588, 22KG72590, 22KG73643, 22KG73371, 22KG73396, 22KG73645, 22KG73740, 22KG68367, 22KG70856, 22KG70859, 22KG70877, 22KG72733, 22KG72965, 22KG73300, 22KG66744, 22KG68402, 22KG71018, 22KG72577, 22KG72974, 22KG73365, 22KG73638, 22KG73667, 22KG75312, 22KG75437, 22KG76456, 22KG76467, 22KG76471, 22KG75139, 22KG76460, 22KG75163, 22KG75442, 22KG73063, 22KG73669, 22KG74499, 22KG75167, 22KG76455, 22KG73010, 22KG76461, 22KG73993, 22KG74880, 22KG74940, 22KG74987, 22KG75060, 22KG75007, 22KG75069, 22KG74923, 22KG74935, 22KG68599, 22KG68682, 22KG68731, 22KG68733, 22KG68779, 22KG68796, 22KG69664, 22KG69681, 22KG69741, 22KG69767, 22KG69831, 22KG69892, 22KG70805, 22KG70838, 22KG70857, 22KG70897, 22KG70899, 22KG70900, 22KG70902, 22KG70909, 22KG70952, 22KG71079, 22KG71094, 22KG71095, 22KG71118, 22KG71704, 22KG71756, 22KG71889, 22KG71898, 22KG71901, 22KG71962, 22KG72423, 22KG72430, 22KG72436, 22KG72437, 22KG72450, 22KG72454, 22KG72482, 22KG72628, 22KG72644, 22KG72651, 22KG72672, 22KG72673, 22KG72683, 22KG72686, 22KG72730, 22KG72859, 22KG72870, 22KG72891, 22KG72921, 22KG73008, 22KG73028, 22KG73307, 22KG73455, 22KG73745, 22KG66796, 22KG70920, 22KG72497, 22KG70801, 22KG71618, 22KG70699, 22KG69704, 22KG71175, 22KG71177, 22KG71191, 22KG71192, 22KG71615, 22KG68532, 22KG69690, 22KG68112, 22KG68544, 22KG68554, 22KG68658, 22KG68682, 22KG68800, 22KG69686, 22KG69667, 22KG69832, 22KG68792, 22KG73100, 22KG72896, 22KG73716, 22KG73744, 22KG72858, 22KG73723, 22KG72647, 22KG71884, 22KG71924, 22KG72633, 22KG72786, 22KG72699, 22KG72757, 22KG73070, 22KG73053, 22KG71835, 22KG71998, 22KG72286, 22KG72527, 22KG72726, 22KG73487, 22KG73507, 22KG73711, 22KG75194, 22KG72574, 22KG73509, 22KG72732, 22KG75194, 22KG74569, 22KG73102, 22KG72671, 22KG72529, 22KG72531, 22KG72652, 22KG72526, 22KG68607, 22KG68609, 22KG68668, 22KG68669, 22KG68888, 22KG68669, 22KG68588, 22KG68635, 22KG71745, 22KG70818, 22KG71072, 22KG71685, 22KG71737, 22KG71743, 22KG71755, 22KG71762, 22KG71764, 22KG71769, 22KG71774, 22KG71777, 22KG71782, 22KG71875, 22KG71894, 22KG71963, 22KG72220, 22KG72245, 22KG72246, 22KG72329, 22KG72456, 22KG72457, 22KG72483, 22KG72487, 22KG72488, 22KG72493, 22KG72494, 22KG72497, 22KG72498, 22KG72503, 22KG72505, 22KG72506, 22KG72508, 22KG72569, 22KG72578, 22KG72581, 22KG72635, 22KG72676, 22KG72723, 22KG72748, 22KG72753, 22KG72755, 22KG72761, 22KG72787, 22KG72788, 22KG72892, 22KG73003, 22KG73039, 22KG73041, 22KG73138, 22KG73213, 22KG73285, 22KG73286, 22KG73310, 22KG73406, 22KG73646, 22KG73646, 22KG73649, 22KG73650, 22KG73655, 22KG73702, 22KG73748, 22KG73753, 22KG73782, 22KG73792, 22KG73807, 22KG73808, 22KG73821, 22KG73834, 22KG73847, 22KG73849, 22KG73852, 22KG73861, 22KG73866, 22KG73868, 22KG73873, 22KG73942, 22KG73961, 22KG73965, 22KG73973, 22KG73979, 22KG74038, 22KG74040, 22KG74105, 22KG74416, 22KG74518, 22KG74537, 22KG74724, 22KG74729, 22KG74746, 22KG74816, 22KG74821, 22KG74847, 22KG74919, 22KG74928, 22KG74939, 22KG74945, 22KG74958, 22KG74960, 22KG74961, 22KG74965, 22KG75165, 22KG75330, 22KG75487, 22KG75490, 22KG75554, 22KG75574, 22KG75575, 22KG76453, 22KG76489, 22KG76496, 22KG76584, and 22KG76585
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on February 6, 2004, by facsimile on February 8, 2004, and by letters on April 30, 2004, and June 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected in an apheresis collection kit that possibly had exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4347 units
DISTRIBUTION
PA, NJ, DE,NY, AL, MD, and PR
______________________________
PRODUCT
Recovered Plasma, Recall # B-1534-5
CODE
Unit number: 1230398
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by facsimile on November 24, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
______________________________
PRODUCT
Source Plasma, Recall # B-1539-5
CODE
Unit numbers: 70764529, 7760880, 70744590, 70741964, 70735703, 70709797, 70686234, 70681727, 70678185, 70674637, 70658460, 70654691, 70650976, 70629507, 70627985, 70621754, 70619966, 70592429, 70592030, 70583779, 0090680711, 0090678805, 0090678497, 0090677771, 0090669046, 0090668733, 0090667055, 0090666353, 0090665202, 0090664854, 0090661910, 0090660807, 0090655735, 0090655287, 0090654605, 0090654378
RECALLING FIRM/MANUFACTURER
Nabi Biopharmaceuticals, Scranton, PA, by facsimile on February 17, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor who had received tattoos, were distributed.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
CA and NC
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1544-5
b) Platelets, Recall # B-1545-5
c) Platelets, Leukocytes Reduced, Recall # B-1546-5
d) Cryoprecipitated AHF, Recall # B-1547-5
e) Recovered Plasma, Recall # B-1548-5
CODE
a) Unit numbers 24KL72567, 24KL67403, 24KL59858, 24KL56536,
24KL43902, 24KM59332, and 24KS33234
b) Unit number 24KM59332
c) Unit numbers 24KL72567, 24KL67403, and 24KL59858
d) Unit number 24KS33234
e) Unit numbers 24KL72567, 24KL67403, 24KL59858, 24KL56536,
24KL43902, 24KM59332, and 24KS33234
RECALLING FIRM/MANUFACTURER
The American National Red Cross, River Valley Region, Louisville, KY, by email on July 12, 2004, and by letters on July 23, 2004, and August 30, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
KY, IN, CA, and Switzerland
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1549-5
CODE
Unit number: 1076525
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter on September 28, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor based on use of the medication Neurontin for treatment of transverse myelitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1551-5
b) Platelets, Recall # B-1552-5
c) Recovered Plasma, Recall # B-1553-5
CODE
a), b), and c) Unit number: 01KH33037
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letter, facsimile, and electronic mail on June 24 and 26, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NY and Switzerland
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1556-5
b) Recovered Plasma, Recall # B-1557-5
CODE
a) and b) Unit numbers: 4012766 and 4020372
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc, Columbia Ogden Medical Center, Ogden, UT, by letter on January 31, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
UT and MO
_______________________________
PRODUCT
Source Plasma, Recall # B-1559-5
CODE
Unit numbers: 45309984, 47091702, 47096857, 47098466
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Birmingham, AL, by facsimile on March 30, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1560-5
CODE
Unit number: 2331282
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on April 5, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had received a piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-1563-5
b) Recovered Plasma, Recall # B-1564-5
CODE
a) and b) Unit number: 18GM13843
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone, e-mail and letter dated February 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for viral markers, but were collected from a donor who was subsequently determined to have multiple risk factors for increased incidence of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and MI
_______________________________
PRODUCT
Source Plasma, Recall # B-1565-5
CODE
Unit numbers: 72648322, 72682210
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Birmingham, AL, by facsimile on January 27, 1997. Firm initiated recall is complete.
REASON
Blood products, that tested negative for Hepatitis B surface antigen (HbsAg), but were collected from a donor that previously tested positive for HbsAG, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
_______________________________
PRODUCT
a) Platelets, Recall # B-1567-5
b) Cryoprecipitated AHF, Recall # B-1568-5
c) Cryoprecipitated AHF, Pooled, Recall # B-1569-5
d) Fresh Frozen Plasma, Recall # B-1570-5
e) Plasma, Cryoprecipitated Reduced, Recall # B-1571-5
f) Plasma, Recall # B-1572-5
CODE
a) Unit numbers 021GC80028, 021GK94494, 021KC17786,
and 021GK92753

b) Unit numbers 021GC36086, 021GC55769, 021GC58535, 021GC68459, 021GC68514, 021GC73127, 021GC74093, 021GC74179, 021GC74661, 021GC74691, 021GC74983, 021GC78003, 021GC79251, 021GC80107, 021GC80118, 021GC80900, 021GC80916, 021GC85181, 021GC91541, 021GC91924, 021GC92245, 021GC92446, 021GC92475, 021GC93296, 021GC95363, 021GC95888, 021GC96937, 021GC97367, 021GC97733, 021GC99309, 021GC99852, 021GC99856, 021GC99857, 021GE19719, 021GE20760, 021GE22964, 021GE24250, 021GE24708, 021GE25055, 021GE25173, 021GE25796, 021GE26129, 021GE26755, 021GE27181, 021GE27630, 021GE27890, 021GE29001, 021GE30140, 021GE30147, 021GE30436, 021GE30476, 021GE30700, 021GE31133, 021GE31844, 021GE32164, 021GE32335, 021GE32371, 021GE32406, 021GE32420, 021GE32532, 021GE32701, 021GE32887, 021GE33579, 021GE33666, 021GE33883, 021GE35882, 021GK92676, 021GK94742, 021GN09866, 021GY47195, 021GY56285, 021GY58298, 021GY59550, 021GY61313, 021GY63257, 021GY64766, 021GY64819, 021GY65522, 021GY65949, 021GY67108, 021GY68183, 021GY68420, 021GY69262, 021GY69638, 021GY70141, 021GY71464, 021GY72380, 021GY73042, 021GY73214, 021GY73228, 021GY73792, 021GY74134, 021GY74141, 021GY75415, 021GY76689, 021GY76794, 021GY77236, 021GY77244, 021GY77247, 021GY77373, 021GY77617, 021GY77652, 021GY78250, 021GY78393, 021GY78412, 021GY78639, 021GY78683, 021GY79293, 021GY79807, 021GY79839, 021GY79950, 021GZ04332, 021GZ05387, 021GZ05392, 021GZ09606, 021GZ09915, 021GZ09962, 021KC06063, 021KC06081, 021KC08961, 021KC10116, 021KC11546, 021KC11658, 021KC12445, 021KC14380, 021KC15937, 021KC17347, 021KC17420, 021KC18109, 021KC19825, 021KC21376, 021KC21792, 021KC21885, 021KC22394, 021KC22866, 021KC24998, 021KC25063, 021KC26292, 021KC26422, 021KC28472, 021KC28640, 021KC28703, 021KC28959, 021KC29992, 021KC33763, 021KC33897, 021KC34655, 021KC34781, 021KC34783, 021KC35111, 021KC35917, 021KC36036, 021KC36839, 021KC37249, 021KC37437, 021KC37799, 021KC38055, 021KC38143, 021KC39118, 021KC39277, 021KC39583, 021KC40699, 021KC40774, 021KC41540, 021KC42621, 021KC43884, 021KC44288, 021KC44345, 021KC44732, 021KC44996, 021KC45144, 021KC45198, 021KC45369, 021KC45514, 021KC45972, 021KC46017, 021KC46485, 021KC46775, 021KC47290, 021KC47522, 021KC48568, 021KC48701, 021KC49097, 021KC49778, 021KE06754, 021KE10825, 021KE11931, 021KE12315, 021KE12319, 021KF17996, 021KG00696, 021KG04701, 021KG26814, 021KG26816, 021KG26831, 021KG27128, 021KG27137, 021KG27289, 021KG33001, 021KG38653, 021KG38784, 021KG38969, 021KG40959, 021KG42547, 021KG43743, 021KG43887, 021KG46136, 021KG46313, 021KG46615, 021KG46877, 021KG47347, 021KG48477, 021KG49098, 021KG49679, 021KG50124, 021KG50237, 021KG50507, 021KG50989, 021KG51036, 021KG51225, 021KG51913, 021KG52351, 021KG52428, 021KG52638, 021KG52707, 021KG52797, 021KG53493, 021KG54090, 021KG54409, 021KG54999, 021KG56023, 021KG56813, 021KG57242, 021KG57270, 021KG57448, 021KG58173, 021KG59003, 021KG60156, 021KG61780, 021KG61791, 021KG62300, 021KG62784, 021KG62882, 021KG63659, 021KG63870, 021KG64234, 021KG64245, 021KG64577, 021KG64698, 021KG65026, 021KG65830, 021KG65849, 021KG65889, 021KG65904, 021KG66728, 021KG66738, 021KG67645, 021KG68166, 021KG68278, 021KG68492, 021KG68557, 021KG69103, 021KG69157, 021KG69238, 021KG69257, 021KG69295, 021KG69320, 021KG69374, 021KG69375, 021KG69921, 021KG70007, 021KG70032, 021KG70396, 021KG70732, 021KG70891, 021KG72133, 021KG72234, 021KG72342, 021KG72355, 021KG76258, 021KH05503, 021KH07596, 021KH07953, 021KH18794, 021KH22378, 021KH28459, 021KH28704, 021KH33028, 021KH33107, 021KH34188, 021KH40699, 021KH42519, 021KH42824, 021KH46148, 021KH46361, 021KH46930, 021KH48097, 021KH48530, 021KH49343, 021KH51097, 021KH51118, 021KH52151, 021KH53695, 021KH54844, 021KH54888, 021KH55129, 021KH55251, 021KH55266, 021KH56212, 021KH57291, 021KH57463, 021KH57779, 021KH58332, 021KH58888, 021KH58974, 021KH59254, 021KH60509, 021KH60980, 021KH61359, 021KH61791, 021KH63799, 021KH63823, 021KH63824, 021KH64659, 021KH64723, 021KH65324, 021KH65601, 021KH66222, 021KH66387, 021KH66434, 021KH66682, 021KH67131, 021KH67390, 021KH67618, 021KH67630, 021KH68536, 021KH68733, 021KH68737, 021KH70644, 021KH70645, 021KH70739, 021KH70741, 021KH70793, 021KH70923, 021KH70960, 021KH71027, 021KH71615, 021KH71677, 021KH71765, 021KH72058, 021KH72808, 021KJ01968, 021KJ26300, 021KJ26339, 021KJ34284, 021KJ38141, 021KJ38564, 021KJ40084, 021KJ40537, 021KJ40730, 021KJ43543, 021KJ44553, 021KJ44754, 021KJ44764, 021KJ45677, 021KJ45678, 021KJ45883, 021KJ46279, 021KJ47254, 021KJ48231, 021KJ48338, 021KJ48354, 021KJ48413, 021KJ49561, 021KJ49698, 021KJ50215, 021KJ50431, 021KJ51073, 021KJ51077, 021KJ51115, 021KJ51397, 021KJ51759, 021KJ51979, 021KJ52704, 021KJ52842, 021KJ53173, 021KJ53700, 021KJ54840, 021KJ56434, 021KJ56853, 021KJ57163, 021KJ58892, 021KJ59089, 021KJ59831, 021KJ61800, 021KJ61861, 021KJ62008, 021KJ62020, 021KJ62081, 021KJ63598, 021KJ63761, 021KJ64832, 021KJ64956, 021KJ64974, 021KJ66643, 021KJ67377, 021KJ68017, 021KJ68153, 021KJ68669, 021KJ69298, 021KJ69517, 021KJ69537, 021KJ69546, 021KJ69562, 021KJ69572, 021KJ70003, 021KJ70185, 021KJ71972, 021KJ73546, 021KK20320, 021KK20429, 021KK20684, 021KK23298, 021KK23348, 021KK31984, 021KK34163, 021KK36305, 021KK39312, 021KK39541, 021KK39651, 021KK39684, 021KK39743, 021KK39953, 021KK40326, 021KK40401, 021KK41905, 021KK42040, 021KK43444, 021KK45179, 021KK46294, 021KK46488, 021KK46499, 021KK46555, 021KK46814, 021KK47072, 021KK47752, 021KK47832, 021KK47921, 021KK49229, 021KK49350, 021KK50186, 021KK53093, 021KK53153, 021KK53242, 021KK53309, 021KK53339, 021KK53342, 021KK54307, 021KK55140, 021KK55492, 021KK57061, 021KK57269, 021KK57275, 021KK57339, 021KK57606, 021KK57902, 021KK58096, 021KK58848, 021KK59185, 021KK60257, 021KK61018, 021KK61113, 021KK64557, 021KL15568, 021KL15766, 021KL20952, 021KL25287, 021KL28156, 021KL28515, 021KL28580, 021KL28687, 021KL31311, 021KL31375, 021KL31402, 021KL33338, 021KL33969, 021KL35254, 021KL35373, 021KL36928, 021KL38066, 021KL43671, 021KL44662, 021KL44913, 021KL44950, 021KL45207, 021KL45847, 021KL46186, 021KL46194, 021KL46349, 021KL46684, 021KL46707, 021KL48121, 021KL48124, 021KL48242, 021KL48277, 021KL48782, 021KL48923, 021KL49075, 021KL49153, 021KL49648, 021KL50143, 021KL50167, 021KL50173, 021KL50181, 021KL50182, 021KL51514, 021KL51518, 021KL51521, 021KL51974, 021KQ01833, 021KQ05008, 021KS05821, 021KS05827, 021KW06235, 021KW06241, 021KW06608, 021KW08100, 021KW08776, 021KW09814, 021KW10041, 021KW10052, 021KW10721, 021KW10751, 021KW10876, 021KW11103, 021KZ03099, 021KZ03160, 021KZ03485, 021KZ06834, 021KZ06853, 021KZ06858, 021KZ09539, 021KZ09958, 021KZ10225, 021V65768, 021V69618, 021V69856, 021V71581, 021V72674, 021V74240, 021V74692, 021V75373, 021V76028, 021V77287, 021V77296, 021V77422, 021V77527, 021V77545, 021V77575, 021V77909, 021V78063, 021V78740, 021V78985, 021V79032, 021V79041, 021V79692, 021V79708, 021V80074, 021V80694, 021V81590, 021V82694, 021W40023, 021W47559, 021W48682, 021W51976, 021W51990, 021W52148, 021Y50066, 021Y61775, 021Y62652, 021Y63152, 021Y63689, 021Y64380, 021Y64644, 021Y64651, 021Y64715, 021Y65467, 021Y65831, 021Y66577, 021Y66902, 021Y68181, 021Y69232, 021Y69471, 021Y69508, 021Y70064, 021Y70264, 021Y70634, 021Y70771, 021Y70938, 021Y71211, 021Y71373, 021Y71548, 021Y71849, and 021Y72608

c) Unit numbers 021GC52581, 021GC87795, 021GC94718, 021GC95350, 021GC97335, 021GE38243, 021GY66866, 021GY75315, 021GY77932, 021GY82767, 021KC19214, 021KC19771, 021KC21442, 021KC21677, 021KC22285, 021KC30387, 021KC36511, 021KC41019, 021KC46770, 021KC46773, 021KC47557, 021KC48481, 021KE10234, 021KF17687, 021KG29818, 021KG29831, 021KG36664, 021KG41777, 021KG43481, 021KG43863, 021KG43864, 021KG46291, 021KG58217, 021KG58227, 021KG67434, 021KG67443, 021KG68163, 021KH03097, 021KH07916, 021KH50933, 021KH57079, 021KH63509, 021KH67606, 021KH68939, 021KJ28087, 021KJ46366, 021KJ49931, 021KJ50653, 021KJ55926, 021KJ67382, 021KK26290, 021KK30577, 021KK35338, 021KK43490, 021KK45082, 021KK49467, 021KK55497, 021KK59935, 021KK67994, 021KL30087, 021KL32025, 021KL33519, 021KL35112, 021KL37004, 021KL38062, 021KL48905, 021KL49614, 021KL50670, 021KL51270, 021KS04736, 021KW04662, 021KW07069, 021KW10480, 021KW14910, 021V68616, 021V72338, 021V74355, 021V78452, 021V78577, 021V80319, 021W44592, 021W52350, 021Y65594, 021Y72084, and 021Y72851

d) Unit numbers 021GC91207, 021GC97692, 021GW29317, 021KH20174, 021KH60006, 021KJ72317, 021KZ03612, and 021W51993 (unit distributed as four split products)

e) Unit numbers 021GC36086, 021GE30140, 021GY63257, 021GY69262, 021GY74141, 021GY75315, 021GY76794, 021GY78091, 021GY78250, 021GY78683, 021KC11658, 021KC17420, 021KC24998, 021KC35917, 021KC41540, 021KC43884, 021KC44732, 021KC45972, 021KC46773, 021KG38653, 021KG43863, 021KG50237, 021KG54409, 021KG56023, 021KG57270, 021KG58217, 021KG59003, 021KG62784, 021KG65830, 021KG65849, 021KG68557, 021KG69238, 021KH05503, 021KH40699, 021KH58888, 021KH63823, 021KH65324, 021KH67630, 021KH71677, 021KH71765, 021KJ44754, 021KJ49561, 021KJ50431, 021KJ61861, 021KJ64974, 021KK35338, 021KK43444, 021KK50186, 021KK53342, 021KK54307, 021KK57061, 021KL28580, 021KL28687, 021KL31375, 021KL31402, 021KL44662, 021KL48124, 021KL48905, 021KL51270, 021KL51521, 021KW10480, 021KW10721, 021KW14910, 021KZ06834, 021KZ06858, 021KZ10390, 021V69856, 021V74692, 021V77527, 021V77545, 021V79032, 021V0319, 021Y61775, 021Y70064, and 021Y71373

f) Unit numbers 021FJ18211, 021FJ21681, 021FJ25117, 021FJ25118, 021FJ26674, 021FJ27526, 021FL33027, 021FL41980, 021FL42206, 021FL44167, 021FL44985, 021FL52018, 021FL52648, 021FL53808, 021FL53913, 021FL60219, 021FL60553, 021FL60970, 021FL61697, 021FL62436, 021FL62454, 021FL62464, 021FL62933, 021FL63598, 021FL63697, 021FL63702, 021FL63726, 021FM55530, 021FM59615, 021FM71647, 021FM71698, 021FM75721, 021FM76197, 021FM76223, 021FM76361, 021FM77434, 021FM77468, 021FM77517, 021FM77736, 021FM78064, 021FM78542, 021FM78997, 021FM79160, 021FQ10292, 021FQ11377, 021FQ11981, 021FQ13309, 021FQ14755, 021FQ14844, 021FS22888, 021FS22920, 021FS22951, 021FS22972, 021FS24970, 021FS25916, 021FS26083, 021FT17198, 021FT19673, 021FT27821, 021FT29195, 021FT36695, 021FT39093, 021FT39142, 021FT39143, 021FT39605, 021FT40344, 021FZ07912, 021FZ08015, 021FZ08025, 021FZ08714, 021FZ09465, 021GC52599, 021GC64501, 021GC99280, 021GC99826, 021GE24989, 021GE30373, 021GK94494, 021GL35166, 021GL57847, 021GL57898, 021GL59324, 021GL60708, 021GL61647, 021GL62039, 021GL63096, 021GL63551, 021GL65755, 021GL66104, 021GL69045, 021GL71111, 021GL72255, 021GL72453, 021GL73217, 021GL73704, 021GL74528, 021GL75324, 021GL76006, 021GL76212, 021GL76384, 021GN10002, 021GN11088, 021GN11448, 021GS03344, 021GS10400, 021GS12674, 021GS13183, 021GS14880, 021GW20385, 021GW26278, 021GW26517, 021GW27483, 021GW27492, 021GW27501, 021GW30896, 021GW34124, 021GY62185, 021GY66479, 021GY69994, 021GY70017, 021GY72582, 021GY72583, 021GY72584, 021GY79094, 021GY79853, 021GY80306, 021GY81635, 021GZ07638, 021KC06061, 021KC09401, 021KC25096, 021KC30188, 021KC30778, 021KC31234, 021KC31453, 021KC44184, 021KE01884, 021KE08433, 021KE12035, 021KE14223, 021KE14632, 021KF05504, 021KF05521, 021KF14867, 021KF21771, 021KF22683, 021KF25017, 021KF25019, 021KF25020, 021KF25023, 021KF25432, 021KF26528, 021KF26781, 021KF27136, 021KG23092, 021KG41799, 021KG54665, 021KG55648, 021KG57504, 021KG69325, 021KH06113, 021KH06153, 021KH07791, 021KH15443, 021KH35771, 021KH46559, 021KH68373, 021KH69948, 021KJ29599, 021KJ33889, 021KJ37011, 021KJ42458, 021KJ53773, 021KJ53868, 021KJ61962, 021KJ65877, 021KJ67796, 021KJ69069, 021KJ70739, 021KK29283, 021KK44829, 021KK45492, 021KK55769, 021KL08639, 021KL26633, 021KL29880, 021KL39337, 021KL42130, 021KL44235, 021KL45731, 021KL45744, 021KL45746, 021KL49625, 021KL49726, 021KL50124, 021KL50168, 021KL52027, 021KM16411, 021KM19161, 021KM20203, 021KM22542, 021KM22623, 021KM23373, 021KM27342, 021KM28242, 021KM28245, 021KM28327, 021KM34044, 021KM35401, 021KM35435, 021KM35627, 021KM38003, 021KM38018, 021KM38280, 021KM39457, 021KM39516, 021KR08540, 021KR09418, 021KR13634, 021KR13998, 021KR20738, 021KS03712, 021KS03920, 021KS05126, 021KS05901, 021KS06198, 021KS06428, 021KS06465, 021KS06960, 021KW03413, 021KW07179, 021KW07187, 021KW08913, 021KW09448, 021KW09926, 021KZ03309, 021KZ06278, 021KZ06296, 021KZ07339, 021KZ09285, 021KZ09388, 021N13786, 021N14366, 021Q98625, 021Q99238, 021V73733, 021V73960, 021V73974, 021V77701, 021W51544, 021W51685, 021W51703, 021W51713, 021W52266, 021Y64067, 021Y64318, 021Y64891, 021Y70204, and 021Y72019
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on September 20, 23, and 25, 2002, and February 24, 2003, and by letters on October 23, 2002, and December 2, 2002. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1038 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1580-5
b) Fresh Frozen Plasma, Recall # B-1581-5
CODE
a) and b) Unit number: 53FW40608
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by telephone on November 19, 2004, and by letter dated November 22, 2004. Firm initiated recall is complete.
REASON
Blood products, manufactured from an overweight unit of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD

RECALLS AND FIELD CORRECTIONS: Biologics - CLASS III

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1336-5
CODE
Unit number: 18236-4626
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter, dated April 13, 2005 85257
Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is complete.
REASON
Platelets Pheresis, associated with a positive bacterial culture, which identified Streptomyces sp. as the isolate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
_______________________________
PRODUCT
Source Plasma, Recall # B-1410-5
CODE
Unit numbers: 05W32, 09U68, 51Q94, 28K83, 67P54, 68Q26
RECALLING FIRM/MANUFACTURER
Mayo Clinic Rochester, Division of Transfusion Medicine,
Rochester, MN, by letters, dated January 12, 2002 and February 3, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors after donor deferral criteria was modified without notifying the FDA, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
CA and FL
_______________________________
PRODUCT
Red Blood Cells, Recall # B-1472-5
CODE
Unit LW15417
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone and letter on June 24, 2002. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had surgery within two weeks of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1475-5
CODE
Unit GJ02793
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone and letter dated November 20, 2002. Firm initiated recall is complete.
REASON
Blood product, which was not manufactured within the acceptable time frame after the time of collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells, Recall # B-1484-5
CODE
Unit number: FM24541
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on February 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had a history of irritable bowel syndrome, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1485-5
CODE
Unit number: GJ12262
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on February 24, 2004. Firm initiated recall is complete.
REASON
Platelets Pheresis, that was labeled leukoreduced but was not tested to determine the white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced
CODE
a) Unit number: 2143825
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Lexington, KY, by letter, dated December 24, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1487-5
CODE
Unit number: 2135345B
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Lexington, KY, by letter, dated December 24, 2004. Firm initiated recall is complete.
REASON
Platelets Pheresis, Exposed to an unacceptable shipping temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
_______________________________
PRODUCT
Recovered Plasma, Recall # B-1492-5
CODE
Unit number: 10186-4086
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Scottsdale, AZ, by electronic mail on November 10, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Germany
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1503-5
CODE
Unit number: J88641
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by letter dated March 31, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a medical history of hemochromatosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1504-5
CODE
Unit numbers: 4486547, 4486551, 4486711, 4486538, 4486552, 4517521, 4517520, 4518204, and 4518203
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by facsimile on September 18, and October 28, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors whose hematocrits were not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
OK
_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1521-5
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1522-5
c) Platelets, Recall # B-1523-5
CODE
a) Unit number: 2069412
b) and c) Unit number: 2101919
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by letters, dated September 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KY
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1535-5
b) Platelets, Leukocytes Reduced, Recall # B-1536-5
c) Fresh Frozen Plasma, Recall # B-1537-5
CODE
a), b), and c) Unit number: 042K62409
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone and letter dated June 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had an internal automatic defibrillator and was taking the medications Altace and Toprol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1550-5
CODE
Unit numbers: 01KK98860 and 01KK98862
RECALLING FIRM
The American National Red Cross, New York-Penn Region, West Henrietta, NY, by telephone on March 9, 2004. Firm initiated recall is complete.
REASON
Blood products, that were found to be out of specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
_______________________________
PRODUCT
Plasma, Cryoprecipitate Reduced, Recall # B-1554-5
CODE
Unit numbers 4754741, 4599990, 4765182, 4759473, 4760624, 4731673, 4747836, 4765178, 4743755, 4746088, and 4748857
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on February 2, 2004. Firm initiated recall is complete.
REASON
Blood products were not re-frozen in the appropriate time frame after removal of cryoprecipitate and were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
OK
_______________________________
PRODUCT
Plasma, Cryoprecipitate Reduced, Recall # B-1555-5
CODE
Unit numbers 4769673, 4748562, 4765760, 4760937, 4774513, 4772483, 4774315, 4748612, 4777609, 4612728, 4776371, 4731332, 4769533, 4744498, 4748070, 4748129, 4769536, 4774999, 4769580, 4769586, 4769584, 4778880, 4778882, 4778883, 4769671, 4769676, 4769674, and 4774498
RECALLING FIRM
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on February 2, 2004. Firm initiated recall is complete.
REASON
Blood products were not re-frozen in the appropriate time frame after removal of cryoprecipitate and were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
OK
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1577-5
CODE
Unit number: 026GG03657
RECALLING FIRM/MANUFACTURER
American Red Cross, Alabama Region, Birmingham, AL, by telephone on August 14, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
_______________________________
PRODUCT
Red Blood Cells, Recall # B-1586-5
CODE
Unit number: FS13697
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on April 5, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: Devices - CLASS I

_______________________________
PRODUCT
a) Vail 500 Enclosed Bed System, Recall # Z-0861-05
b) Vail 1000 Enclosed Bed System, Recall # Z-0862-05
c) Vail 2000 Enclosed Bed System, Recall # Z-0863-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Vail Products, Inc., Toledo, OH, by letter, dated May 6, 2005. Firm initiated recall is ongoing.
REASON
Risk of patient entrapment, may result in serious injury or death.
VOLUME OF PRODUCT IN COMMERCE
4496 units
DISTRIBUTION
Nationwide, Canada and Saudi Arabia
_______________________________
PRODUCT
Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber. VENTAK PRIZM 2 ICDs are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy. Recall # Z-0906-05
CODE
Serial number range 118626 - 243772 includes ICDs manufactured prior to November 13, 2002. This range includes all affected devices but may include some unaffected devices.
RECALLING FIRM
Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by letters, dated May 23, 2005 and June 17, 2005, and by press release on May 25, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
Laboratory analysis of returned devices revealed that deterioration in a wire insulator within the lead connector block, in conjunction with other factors, resulted in an electrical short. The short may cause diversion of shock therapy energy away from the heart and into device circuitry.
VOLUME OF PRODUCT IN COMMERCE
37,000 defibrillators
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
a) CONTAK RENEWAL (model H135) Heart Failure Device Cardiac
Resynchronization Therapy Defibrillators (CRT-Ds).
Renewal provides ventricular tachyarrhythmia and cardiac
resynchronization therapies. Recall # Z-0907-05;
b) CONTAK RENEWAL 2 (model H155) Heart Failure Device.
Renewal provides ventricular tachyarrhythmia and cardiac
resynchronization therapies. Recall # Z-0908-05
CODE
a) Serial number range 100027 - 999983 includes CRT-Ds
manufactured on or before August 26, 2004. These ranges
include all affected devices but may include some
unaffected devices.;
b) Serial number range 173277 - 777182 includes CRT-Ds
manufactured on or before August 26, 2004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by press release and letter dated June 17, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.
VOLUME OF PRODUCT IN COMMERCE
16,000 (approximately 11,900 remain implanted worldwide)
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: Devices - CLASS II

_______________________________
PRODUCT
AccuSure Insulin Syringe, lcc, 28 guage, ½”, packaged in boxes of 100, each containing 10 bundles of 10 syringes, disposable, NDC 0603-6996-21, Recall # Z-0942-05
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Qualitest Pharmaceuticals, Inc, Huntsville, AL, by press release and letter on June 14, 2005.
Manufacturer: Shin Chang Medical Co., Ltd, Gumi-Shi, Kyungsangbuk-Do, Korea. Firm initiated recall is ongoing.
REASON
Labeling error. There is a possibility that 1cc syringes are labeled at 1/2cc on the plastic inner wrap holding bundles of 10 syringes.
VOLUME OF PRODUCT IN COMMERCE
14,400 boxes of 100 syringes
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Baxter Interlink System Continu-Flo Solution Set with Large Bore 4-Way Stopcock Extension Set, 10 drops/mL, product code 3C0062s; a sterile, nonpyrogenic fluid pathway for administration of IV fluids, Recall # Z-0943-05
CODE
Lot numbers R04D28173, R04D28181, R04D28199, R04F22288, R04F23237, R04F25273, R04G24100, R04G26071, R04H12020, R04H13085, R04H13242, R04H30303, R04I21151, R04J06227, R04J07076, R04J07092, R04J28122, R04K08064, R04K08221, R04K26090, R04K29086, R04L09110, R04L17055, R04L17188, R04L18137, R05A20092, R05A20217, R05B03187, R05B04060, R05B28192
RECALLING FIRM
Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated April 21, 2005.
Manufacturer: Baxter Productos Medicos Ltda., Cartago, Costa Rica. Firm initiated recall is ongoing.
REASON
There is an unsecure connection between the male Luer and the stopcock on the I.V. extension set.
VOLUME OF PRODUCT IN COMMERCE
197,832 sets
DISTRIBUTION
Nationwide, American Samoa and Venezuela
_______________________________
PRODUCT
a) CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175)
and CONTAK RENEWAL 3 HE CRT-D(model no. H177 and H179).
Cardiac Resynchronization Therapy Defibrillator.
CONTAK RENEWAL 3 devices provide ventricular
tachyarrhythmia and cardiac resynchronization therapies.
Recall # Z-0949-05;
b) CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and
CONTAK RENEWAL 4 HE CRT-D (model no. H197 and H199).
Cardiac Resynchronization Therapy Defibrillator.
CONTAK RENEWAL 4 devices provide ventricular
tachyarrhythmia and cardiac resynchronization therapies.
Recall # Z-0950-05;
c) CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155)
and CONTAK RENEWAL 3 AVT HE CRT-D(model no. M157
and M159) Cardiac Resynchronization Therapy
Defibrillator. CONTAK RENEWAL 3 AVT devices provide
both atrial and ventricular tachyarrhythmia and cardiac
resynchronization therapies. Recall # Z-0951-05;
d) CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175)
and CONTAK RENEWAL 4 AVT HE CRT-D (model no. M177 and
M179). Cardiac Resynchronization Therapy Defibrillator.
CONTAK RENEWAL 4 AVT devices provide both atrial and
ventricular tachyarrhythmia and cardiac
resynchronization therapies. Recall # Z-0952-52;
e) CONTAK RENEWAL 4 RF (model no. H230 and H235) and
CONTAK RENEWAL 4 RF HE (model no. H239). Cardiac
Resynchronization Therapy Defibrillator.
CONTAK RENEWAL 4 RF devices provide ventricular
tachyarrhythmia and cardiac resynchronization
therapies. Recall # Z-0953-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by letter dated June 23, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
Engineering analysis has determined that the magnetic switch in certain devices may stick in the closed position. When the magnetic switch becomes stuck in the closed position treatment of ventricular or atrial tachyarrhythmias is inhibited, while bradycardia pacing is unaffected.
VOLUME OF PRODUCT IN COMMERCE
58,062 units
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
a) Ventak Prizm Avt model no, 1900, Atrial and Ventricular
Therapies, Recall # Z-0954-05;
b) Ventak Prizm Avt model A135 and model A155. Implantable,
Cardioverter Defibrillator. Atrial and Ventricular
Therapies, Recall # Z-0955-05;
c) CONTACT RENEWAL 3 AVT model numbers M150 and M155;
CONTACT RENEWAL 3 AVT HE model numbers M157 and M159;
CONTACT RENEWAL 4 AVT model numbers M170 and M175;
CONTACT RENEWAL 4 AVT HE model numbers M177 and M179.
Cardiac Resynchronization Therapy Defibrillator.
CONTAK RENEWAK AVT models provide both atrial and
ventricular tachyarrhythmia and cardiac
resynchronization therapies, Recall # Z-0956-05
CODE
All serial numbers
RECALLING FIRM
Recalling Firm: Guidant Corp-Cpi Division, Saint Paul, MN, by letter dated June 17, 2005.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional “latching” that limits available therapy.
VOLUME OF PRODUCT IN COMMERCE
25,716 devices
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
a) Ultra Z 90 X-Ray Computed Tomography Scanners.
These scanners were sold under the brand names:
Picker, Marconi or Philips, Recall # Z-0957-05;
b) AcQSim X-Ray Computed Tomography Scanners.
These scanners were sold under the brand names:
Picker, Marconi or Philips, Recall # Z-0958-05
CODE
All devices manufactured between January 1996 and June, 2004 were subject to recall
RECALLING FIRM/MANUFACTUREtR
Philips Medical Systems (Cleveland), Inc, Cleveland, OH, by letter, dated March 23, 2004. Firm initiated recall is ongoing.
REASON
Software anomaly in the DICOM Modality Worklist. When restoring a patient’s images from the optical disk, images from the wrong patient may be displayed.
VOLUME OF PRODUCT IN COMMERCE
44 devices
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
Spectre brand AC wall adapter to be used with ProControl 2 or ProHand battery powered upper limb prosthesis, Recall # Z-0959-05
CODE
Part number PD1880 PL6A
RECALLING FIRM
Motion Control, Inc., Salt Lake City, UT, by telephone, on February 1, 2005. Firm initiated recall is ongoing.
REASON
Incorrect AC wall adapter was distributed with prostheses. Incorrect use of adapters could damage the battery and cause a potential fire hazard.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
CA, DC, FL, NJ, OH, PA, SC, TN, TX, and PR
_______________________________
PRODUCT
10 French Ross Flexiflo Lap J Laproscopic Jejunostomy Kit with Brown/Mueller T-F Fastener Set (list #51442), Recall # Z-0960-05
CODE
Lot 13978GZ, exp. date 02/01/2007; Lot 17165GZ, exp. date 06/01/2007; Lot 18190GZ, exp. date 07/01/2007; Lot 19257GZ, exp. date 08/01/2007; Lot 22355, exp. date 11/01/2007; Lot 24440GZ, exp. date 01/01/2008; Lot 26509GZ, exp. date 02/01/2008; Lot 27530GZ, exp. date 02/01/2008
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Columbus, OH, by letter, dated June 16, 2005. Firm initiated recall is ongoing.
REASON
The kits contain a 12 Fr. Introducer Tear-Away BNS component. The tearaway introducer sheaths may have cracked hubs/handles and/or improper peeling of the sheath during use in a small percentage of the affected lots.
VOLUME OF PRODUCT IN COMMERCE
1,892 kits
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
Portex HEPA Bacterial/Viral Filter, Non-Latex Ref: 002890, Recall # Z-0961-05
CODE
Lot Number: 634418
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical International Ltd, Hythe, UK, by letter dated June 3, 2005.
Manufacturer: Smiths Healthcare Manufacturing Sa De Cv, Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label.
VOLUME OF PRODUCT IN COMMERCE
292 units
DISTRIBUTION
CA, NJ, PA, WV
_______________________________
PRODUCT
a) Boston Scientific brand Low Profile PEG (percutaneous
endoscopic gastrostomy tubes) Kit, 18/2.4, pull;
Catalog number 6314. Z-0962-05;
b) Boston Scientific brand Standard PEG (percutaneous
endoscopic gastrostomy tubes) Kit, 20 Fr, pull;
catalog number 6820. Recall # Z-0963-05;
c) Boston Scientific brand Standard PEG (percutaneous
endoscopic gastrostomy tubes) Kit, 20 Fr, push;
catalog number 6821. Recall # Z-0964-05;
d) Boston Scientific brand Standard PEG (percutaneous
endoscopic gastrostomy tubes) Kit, 24 Fr, pull;
catalog number 6824. Recall # Z-0965-05;
e) Boston Scientific brand Standard PEG (percutaneous
endoscopic gastrostomy tubes) Kit, 24 Fr, push;
catalog number 6825. Recall # Z-0966-05;
f) Boston Scientific brand pull Gastro-dome (percutaneous
endoscopic gastrostomy tubes) Kit, 20 Frl;
catalog number 6838. Recall # Z-0967-05;
g) Boston Scientific brand pull Gastro-dome (percutaneous
endoscopic gastrostomy tubes) Kit, 24 Frl; catalog
number 6839. Recall # Z-0968-05;
h) Boston Scientific brand One Step Button (percutaneous
endoscopic gastrostomy tubes) Kit, 18/4.4 pull;
catalog number 6848. Recall # Z-0969-05;
i) Boston Scientific brand One Step Button (percutaneous
endoscopic gastrostomy tubes) Kit, 24/2.4 pull;
catalog number 6851. Recall # Z-0970-05;
j) Boston Scientific brand One Step Button (percutaneous
endoscopic gastrostomy tubes) Kit, 24/3.4 push;
catalog number 6852. Recall # Z-0971-05;
k) Boston Scientific brand One Step Button (percutaneous
endoscopic gastrostomy tubes) Kit, 24/1.7 push;
catalog number 6860. Recall # Z-0972-05
CODE
a) Lot number: 7564877;
b) Lot numbers: 7511185, 7511184, 7423558, 7421294,
7421292, 7393128, 7411790, 7411788, 7411787, 7389202,
7410534, 7410533, 7407840, 7407839, 7407838 and
7421293;
c) Lot numbers: 7397623, 7393130 and 7393129;
d) Lot number: 7406777;
e) Lot number: 7404367;
f) Lot numbers: 7452729, 7448186, 7426909 and 7385202;
g) Lot numbers: 7452728, 7442432, 7430336 and 7397622;
h) Lot number: 7467697;
i) Lot numbers: 7471765, 7471766, 7434813, 7471767
and 7434812;
j) Lot numbers: Lots 7467759, 7434810, 7477229, 7434811
and 7401901;
k) Lot number: 7467761
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp, Spencer, IN, by letter dated June 7, 2005. Firm initiated recall is ongoing.
REASON
Two blades may be heat staked onto the stiletto instead of the expected one blade.
VOLUME OF PRODUCT IN COMMERCE
1,366 Kits
DISTRIBUTION
Nationwide and Panama
_______________________________
PRODUCT
RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560, Recall # Z-0975-05
CODE
Lot Number: 1007
RECALLING FIRM
Recalling Firm: Straumann Manufacturing, Inc., Andover, MA, by letter dated June 6, 2005.
Manufacturer: Instituit Strauman, Basel, Switzerland. Firm initiated recall is complete.
REASON
Basal screw is too short to adequately hold the dental abutment in the implant.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
AZ, CA, DE, FL, NY, OH, OK, and TX
_______________________________
PRODUCT
a) Accu-Chek Compact Blood Glucose Meter; catalog number
3183572, Recall # Z-0976-05;
b) Accu-Chek Compact Care Kit; catalog number 3149137,
Recall # Z-0977-05
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp, Indianapolis, IN, by letter dated May 18, 2005.
Manufacturer: Sanmina SCI, Fermoy, Ireland. Firm initiated recall is ongoing.
REASON
The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.
VOLUME OF PRODUCT IN COMMERCE
1,760,000 units
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
a) Accu-Chek Instant Blood Glucose Meter; Catalog numbers
914 and 924, Recall # Z-0978-05;
b) Accu-Chek Instant Care Kit; Catalog number
91490, Recall # Z-0979-05
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp, Indianapolis, IN, by letter dated May 18, 2005.
Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.
VOLUME OF PRODUCT IN COMMERCE
100,000 units
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
LifeScan brand One Touch UltraSmart Blood Glucose Meter Owners Booklet AW 060-788-01A; All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner’s Booklet AW 060-788-01A are affected by this Field Correction. Recall # Z-0980-05
CODE
All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner’s Booklet AW 060-788-01A are affected by this Field Correction. Part Number, Description: 020-524-01, System,OUS,US; 020-524-01F, System,OUS,US; 020-524-01Y, UltraSmart Meter; 020-524-02, System,OUS,EAS-C,US; 020-524-03, System,OUS,EAS-S,US; 020-524-04F, OT UltraSmart System Kit V. 4 USA; 020-524-04Y, UltraSmart System; 020-524-05, UltraSmart System -EAS-C; 020-524-06, UltraSmart System -EAS-S; 020-524-10, OT UltraSmart System Kit; 020-524-10F, OT UltraSmart System Kit; OT UltraSmart System Kit V. 10 USA; 020-524-10Y, OT UltraSmart System Kit; 020-524-11, System, EAS-C, OUS, US; 020-524-12, System, EAS-S, OUS, US; 020-524-13, OT UltraSmart System; 020-759-02F, OT UltraSmart Meter V.2 USA; 020-759-03F, OT UltraSmart Meter V.3 USA; 020-761-01F, Starter,OUS,US; 020-761-02, OT UltraSmart Starter; 020-761-02F, OT UltraSmart Starter; 020-761-04, OT UltraSmart Starter; 020-761-04F OT UltraSmart Starter; 020-761-05 OT UltraSmart Starter Kit; 020-761-05F, OT UltraSmart Starter Kit; 020-926-01, Dist Kit,SM,OTU,US; 020-930-01, Dist,Kit,OTU/OUS,US; 020-971-01, Disp,Counter,Ultra Kits; 021-075-01, UltraSmart SVP; 021-113-01, Display, Hanging, OUT/OUS, US; 021-133-01, Display, Counter, OTU/OUS Kits; 021-135-01, Span Display, Hanging, OTU, US; and 021-166-01, Display, Hanging, OTU/OUS Kits.
RECALLING FIRM/MANUFACTURER
LifeScan Inc, Milpitas, CA, by letters on June 9, 2005. Firm initiated recall is ongoing.
REASON
Meter labeling (Owner’s Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message “Do you need a snack” for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays the message, “Do you need a snack?” for glucose values from 20 through 59 mg/dL.
VOLUME OF PRODUCT IN COMMERCE
584,291 units
DISTRIBUTION
Nationwide and Internationally
_______________________________
PRODUCT
Clinician Workstation Software, product code 2M5042, Recall # Z-0981-05
CODE
Software versions 3.4, 4.0 and 4.1
RECALLING FIRM
Recalling Firm: Baxter Healthcare, Corp, Round Lake, IL, by letters dated March 10, 2005.
Manufacturer: Baxter Healthcare, Corp/Patient Care System, Toronto, Canada. Firm initiated recall is ongoing.
REASON
The medication administration results displayed in the “View Results” link may be inaccurate.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MO, MA, VT, CA, and Canada
______________________________
PRODUCT
Aplio Diagnostic Ultrasound System (SSA-770A), Recall # Z-0982-05
CODE
Software versions 6.0er001 and 002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Systems, Inc., Tustin, CA, by letter on May 23, 2005.
Manufacturer: Toshiba, Japan. Firm initiated recall is ongoing.
REASON
If the measurement mode is started from the Doppler mode and then sweep speed setting is changed by the assigned user function, the measurement of the time direction results don’t correspond to the actual values.
VOLUME OF PRODUCT IN COMMERCE
106 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
TaqMan HBV Analyte Specific Reagent, Material Number 3322092018, containing HBV Quantitation Standard (HBV QS), Recall # Z-0983-05
CODE
Lot number: F10185;
Lot number: F10513
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Somerville, NJ, by letter on February 14, 2005. Firm initiated recall is complete.
REASON
Low level of recombinant HIV DNA found in one lot of HBV QS which is a component of one lot of the TaqMan HBV ASR.
VOLUME OF PRODUCT IN COMMERCE
14 kits
DISTRIBUTION
NC
______________________________
PRODUCT
Lifepak 20 defbrillator/monitor, Part numbers: 3202487-xxxd and 3202488-xxx, Recall # Z-0984-05
CODE
Various, noncontiguous serial numbers
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on June 17, 2005. Firm initiated recall is ongoing.
REASON
The device defibrillator may not operate if the device is turned on during an AC Loss Alert.
VOLUME OF PRODUCT IN COMMERCE
3,924 units
DISTRIBUTION
Nationwide and Internationally
_________________________________________________
PRODUCT
Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing Screener.) Recall # Z-0985-05
CODE
Product order numbers 010038, 010049, 010050, 010065, 010067, 010073, 010085, 030534, 040664, 040700, 040703, 040847, DM010038, DM010039, DM010049, DM010067, DM010074, LN030534. Serial numbers include P3 0547-P3 3404
RECALLING FIRM
Natus Medical, Inc, San Carlos, CA, by letter, on June 28, 2005. Firm initiated recall is ongoing.
REASON
Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.
VOLUME OF PRODUCT IN COMMERCE
2,473 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
Magnetic Resonance Imaging Systems; Visart, Excelart / Excelart P2 / Excelart P3 / Excelart SPIN & Excelart Vantagae, Recall # Z-0986-05
CODE
All codes
RECALLING FIRM
Recalling Firm: Toshiba American Med Systems, Inc, Tustin, CA, by letter on May 25, 2005. Technicians will correct the software by visit beginning on May 25, 2005. Manufacturer: Matsushita Communication Industrial Co., Ltd, Hanishina-Gun, Japan. Firm initiated recall is ongoing.
REASON
Patient information A is displayed with images of patient B.
VOLUME OF PRODUCT IN COMMERCE
103 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
a) Axiom Aristos TX. Model number 58 94 873
Radiology system, Recall # Z-0988-05;
b) Axiom Aristos MX/VX. Model number 58 95 003,
Recall # Z-0989-05;
c) Axiom Aristos FX. Model number 74 14 803,
Recall # Z-0990-05
CODE
a) Serial numbers 1001 through 1077;
b) Serial numbers 1001 through 1017,
1019 through 1071, and 1073 through 1469;
c) Serial numbers 1001 through 1003,
1005 through 1047, and 1049 through 1247
RECALLING FIRM
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on June 10, 2005.
Manufacturer: Siemens Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing.
REASON
Potential issue (system may lock up) when repeating patient registrations.
VOLUME OF PRODUCT IN COMMERCE
72 units
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Medtronic Sofamor Danek brand METRx System
16 mm Med Procedure Kit; Ref 9560016,
Recall # Z-0991-05;
b) Medtronic Sofamor Danek brand METRx System
18 mm Med Procedure Kit; Ref 9560018,
Recall # Z-0992-05;
c) Medtronic Sofamor Danek brand METRx System
MD Procedure Kit; Ref 9560030.
Recall # Z-0993-05
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Warsaw Orthopedic, Inc., Warsaw, IN, by letter dated June 20, 205. Firm initiated recall is ongoing.
REASON
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
VOLUME OF PRODUCT IN COMMERCE
2,493 kits
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Smith & Nephew Grasper, Cupped 3.4mm REF: 011014, Recall # Z-0973-05
CODE
Lot Number: 50088937
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA, by letter dated April 6, 2005. Firm initiated recall is ongoing.
REASON
Cupped Grasper Handle marked incorrectly as Duckbill Upbiter.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CA, OH, MA, and TX
_______________________________
PRODUCT
PG910 Spacers, Part number SP101, loaded into Bard® Express Seeding Cartridges containing TheraSeed® Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch. Recall # Z-0974-05
CODE
Lot #RR13N101L and RR13N101Q
RECALLING FIRM
Recalling Firm: Theragenics Corporation, Buford, GA, by telephone and email on May 16, 2005.
Manufacturer: Ethicon, Inc., Cornelia, GA. Firm initiated recall is ongoing.
REASON
The spacers loaded in the seeding cartridges were expired and/or the extra loose spacers were labeled with an incorrect expiration date.
VOLUME OF PRODUCT IN COMMERCE
13 loads
DISTRIBUTION
OH and VA
_______________________________
PRODUCT
Claris Cleaning and Soaking Solution, 4 fl. oz., Recall # Z-0987-05
CODE
Lot numbers: AA00785, AA00786, AA01050, AA01076
RECALLING FIRM/MANUFACTURER
Recalling Firm: Allergan Medical Optics, Inc., Santa Ana, CA, by letter on June 13, 2005.
Manufacturer: Advanced Medical Optics Manufacturing Spain, Alcobendas (Madrid), Spain. Firm initiated recall is ongoing.
REASON
Component mix-up of caps/tips. Absence of red tip indicates improperly that the solution is safe for application to the eye.
VOLUME OF PRODUCT IN COMMERCE
32,916
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR July 20, 2005

###

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