FDA

Enforcement Report

May 26, 2004
04-21

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Stop & Shop Cookie Jar Dutch Windmill Cookies, Net Wt. 10
ounces. Recall # F-205-4.
CODE
Best if used by date: "SEP13043A".
RECALLING FIRM/MANUFACTURER
Bremner Inc, Div. Of Ralcorp Holdings, Inc., St. Louis, MO, by telephone and e-mail on March 31, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared almonds and peanuts.
VOLUME OF PRODUCT IN COMMERCE
672 cases (twelve 10 oz packages per case).
DISTRIBUTION
MA, CT, RI, NH, NY, and NJ.

_______________________________
PRODUCT
Organic Planet brand Organic Hulled Sesame Seed, Packed in
25 pound 3-ply paper bags, Product of India. Recall # F-
207-4.
CODE
Production Code: 28322-02 1663, Organic Lot #: 000374 P-02/01/P-02/02.
RECALLING FIRM/MANUFACTURER
H. P. Schmid, Inc, San Francisco, CA, by telephone and letters on March 29, 2004. FDA initiated recall is complete.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
160 bags.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
DeMoulas Market Basket Complete Pancake & Waffle Mix, Net
Wt. 908g (32 oz.) 2 lb. Recall # F-208-4.
CODE
All lot codes.
RECALLING FIRM/MANUFACTURER
Market Basket/DeMoulas Super Markets, Boston, MA, by press release and e-mail on March 26, 2004, and by e-mail on March 27, 2004. Firm initiated recall is complete.
REASON
Product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
715 cases.
DISTRIBUTION
MA, and NH.

_______________________________
PRODUCT
a) McDonald's Lightly Salted Butter, Net Wt. 16 oz. (l lb)
454 grams, made for McDonald's Restaurants. Recall #
F-211-4;
b) 1) Land O' Lakes Sweet Cream Salted Whipped Butter, Net
Wt. 5 Lbs., in plastic tubs, two 5 pound tubs per
case;
2) Zander's Whipped Butter, Net Wt. 5 Lbs., in plastic
tubs, four 5 pound tubs per case;
3) Zander's Whipped Butter, Net Wt. 3 Lbs., in plastic
tubs, four 3 pound tubs per case;
4) GFS Gordon Food Service Whipped Butter, Net Wt. 5
Lbs., in plastic tubs, two 5 pound tubs per case;
5) Zanders Sealed Whip Butter Cups Portion Control
Servings, 72-6.3 Gram Cups Per Lb., 720 Cup Servings,
Net Wt. 10 Lbs. (4.54 kg) in cases;
6) Zanders Sealed Whip Butter Cups Portion Control
Servings, 90-5.0 Gram Cups Per Lb., 720 Cup Servings,
Net Wt. 8 Lbs. (3.63 Kg) in cases;
7) GFS Gordon Food Service Whipped Butter Cups, 720
Cups, 90-5 Gram Servings Per Lb., Net Wt. 8 Lbs.
(3.63 Kg) in cases;
8) Deerfield Whipped Butter, Net Wt. 5 Lbs., in plastic
tubs, two 5 pound tubs per case; and
9) I. Lederman Whipped Butter, Net Wt. 5 Lbs., in
plastic tubs, four 5 pound tubs per case.
Recall # F-212-4;
c) 1)Zander's Butter, Net Wt. 16 OZ. (1 LB.) 453 Grams;
Nugget Salted Butter, Net Wt. 1 LB. (16 OZ.) 453 Grams;
Pocahontas Sweet Cream Butter Salted, Net Wt. 1 LB. (16 OZ.) 453 grams;
GFS Gordon Food Service Butter, Net Wt. 16 OZ. (1 LB.) 453 grams;
Elegant Continental Chips (of butter), 47 Cuts Per Lb., Net Wt. 17 Lbs. (7.71 Kg), in cases; each case contains four cartons of Elegantly Wrapped Continental Butter Chips, 200 Individually Foil Wrapped Chips, Net Wt.: 4 1/4 Lbs., 47 Service Portions Per Lb., 200 - .34 oz. Portions (4.25 Lb) /200-9.6 gr. portions;
Elegant Continental Chips (of butter), 59 Cuts per lb., Net Weight 17 lbs. (7.71 kg), 1000 Foil Wrap Portions, in cases; each case contains five cartons of Elegantly Wrapped Continental Butter Chips, 200 Individually Foil Wrapped Chips, Net Wt.: 3.4 Lbs., 59 Service Portions Per Lb., 200 - .27 oz. portions (3.4 Lb) /200-7.7 gr. portions;
GFS Gordon Food Service Continental Butter Chips, 47 Ct. Per Lb., 4-200 Ct. Cartons, Net Wt. 17 Lbs. (7.71 kg), in cases; each case contains four cartons of Elegantly Wrapped Continental Butter Chips, 200 Individually Foil Wrapped Chips, Net Wt.: 4 1/4 Lbs., 47 Service Portions Per Lb., 200 - .34 Portions (4.25 Lb) /200-9.6 gr. portions;
GFS Gordon Food Service Continental Butter Chips, 59 Ct. Per Lb., 5 - 200 Ct. Cartons, Net Wt. 17 Lbs. (7.71 kg), in cases; each case contains five cartons of Elegantly Wrapped Continental Butter Chips, 200 Individually Foil Wrapped Chips, Net Wt.: 3.4 Lbs., 59 Service Portions Per Lb., 200 - .27 Portions (3.4 Lb) /200-7.7 gr. portions;
Sealed Butter Cups, Portion Control Servings, 90 - 5.0 Gram Cups Per Lb., 720 Cup Servings, Net Wt. 8 Lbs. (3.63 Kg) in cases;
10)GFS Gordon Food Service Butter Cups, 720 Cups, 90 - 5
gram Servings Per Lb., Net Wt. 8 Lbs. (3.63 Kg),
49548, in cases;
11)Sweet Cream Butter Patties, 6-5 lb. Cartons; each
case contains six cartons of Fresh Creamery Butter in
Convenient Pats, 5 Lb per carton, in 90 cut, 72 cut,
18 cut and 12 cut per pound pattie sizes;
12)Butter (bulk), Net Wt. 10 Lb/4.45 Kg. per case; 13)Zander's Butter (bulk), Net Wt. 55.12 Lb/25 Kg. per
case; and
14)Zander's Butter (bulk), Net Wt. 68 Lb. per case.
Recall # F-213-4;
d) 1) Sealed Cups, Portion Control Servings (of Butterine),
(90-5.0 Gram Cups Per Lb.), 720 Cup Servings, Net Wt.
8 Lbs. (3.63 Kg) in cases; the foil covers of the
cups
are labeled Butterine Margarine Made with 40% Butter; 2) Zander's Butterine Margarine, 60% Margarine, 40%
Sweet Cream Butter, Net Wt. 16 OZ. (1 LB.) 453 grams; 3) Zander's Butterine Margarine, 60% Margarine, 40%
Sweet Cream Butter, 4 Quarters, Net Wt. 16 OZ. (1
LB.) 453 grams;
4) Zander's Butterine (bulk 60% margarine/40% butter
blend), Net Wt. 68 Lb. per case;
5) Crystal Farms 60% Margarine - 40% Butter, Butter
Blend Margarine, Net Wt 16 OZ. (1 LB.) 454 grams, and 6) Crystal Farms 60% Margarine - 40% Butter, Butter
Blend Margarine, 4 Quarters, Net Wt. 16 OZ. (1 LB.)
454 grams. Recall # F-214-4;
e) 1) Zander's Unsalted Sweet Butter, Net Wt. 16 OZ. (1
LB.) 453 Grams;
2) Nugget Sweet Cream Butter, Unsalted, Net Wt. 1 LB.
(16 OZ.) 453 Grams;
3) Pocahontas Sweet Cream Butter, Unsalted, Net Wt. 1
LB. (16 OZ.) 453 grams;
4) GFS Gordon Food Service Unsalted Butter, Net Wt. 16
OZ. (1 LB.) 453 grams;
5) Golbon Sweet Cream Unsalted Butter, Net Wt. 1 LB. (16
OZ.) 453 grams;
6) Bon Vivant European Style Unsalted Gourmet Butter,
Net Wt. 454 grams, 1 LB., 16 OZ;
7) Elegant Continental Chips (of unsalted butter), 47
Cuts Per Lb., Net Wt. 17 Lbs. (7.71 Kg), in cases;
each case contains four cartons of Elegantly Wrapped
Continental Butter Chips, 200 Individually Foil
Wrapped Chips, Net Wt.: 4 1/4 Lbs., 47 Service Portions
Per Lb., 200 - .34 oz. Portions (4.25 Lb) /200-9.6
gr. portions;
8) Elegant Continental Chips (of unsalted butter), 59
Cuts per lb., Net Weight 17 lbs. (7.71 kg), 1000 Foil
Wrap Portions, in cases; each case contains five
cartons of Elegantly Wrapped Continental Butter
Chips, 200 Individually Foil Wrapped Chips, Net Wt.:
3.4 Lbs., 59 Service Portions Per Lb., 200 - .27 oz.
portions (3.4 Lb) /200-7.7 gr. portions;
9) Zander's Unsalted Butter (bulk), Net Wt. 68 Lb. per
case; and
10) Deerfield Unsalted Creamery Butter, Net Wt. 16 OZ.
(1 LB.) 453 grams. Recall # F-215-4.
f) 1) Zander's Whipped Butterine, 60% Margarine, 40%
Butter, Net Wt. 5 Lbs. (80 Oz.), in plastic tubs,
four 5 pound tubs per case; and
GFS Gordon Food Service Whipped Margarine, 60%
Margarine / 40% Butter Blend, Net Wt. 5 Lbs. (2.27
kg), in plastic tubs, two 5 pound tubs per case, Recall # F-216-4;
g) Butter Churned Blend Spread (in portion control
servings), 90 Count Cups (per lb.), Net Wt. 8 Lbs. in
cases. Recall # F-217-4;
h) Whipped Butter Blend Spread, Net Wt. 5 Lbs., in plastic
tubs, four 5 pound tubs per case. Recall # F-218-4.
CODE
a) The shipping case code is "Best If Used By 06/12/04 and
06/13/04". The individual wrapper code is "061204 34470"
and "061304 34470".
b), c), d), e), and f) Codes beginning with 043 to 100 as
the first three digits;
g), and h) Code 050-80-703 only.
RECALLING FIRM/MANUFACTURER
Zander's Creamery, Inc., Cross Plains, WI, by telephone on February 27, 2004, and by letters dated March 5, 2004 and April 15, 2004. FDA initiated recall is ongoing.
REASON
Samples of some of the recalled products tested positive for Listeria monocytogenes and the other recalled products were made on the same equipment, as used for the products which tested positive.
VOLUME OF PRODUCT IN COMMERCE
4,000,000 pounds.
DISTRIBUTION
Nationwide.

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PRODUCT
a) Containers of cut honeydew or cantaloupe alone, or mixed
with a variety of other fruits. Any of the products may
contain "MARY'S Selected" brand, or products do not have
a brand. Cut honeydew. Product identified in one of the
following ways: "Honeydew" in 8 oz. or 16 oz. plastic
cups, "HONEYDEW CHUNKS" in 8 oz. plastic cups;
"American Deli Honeydew 5#" in 5 lb. plastic tray;
"Honeydew 1/2 cut" in 20 lb. plastic tray, "Honeydew
Wedge 5# in plastic tray. Recall # F-223-4;
b) Cut cantaloupe. Product identified in one of the
following ways: "Cantaloupe" in 8 oz, 16 oz. or 40 oz.
plastic cup, "Cantaloupe 1/2 cut" in 20 lb. plastic
tray, "American Deli Cantaloupe" in 5 lb. plastic tray,
"Cantaloupe Wedge" in 1 lb. plastic bags and 5 lb.
plastic tray, "Fresh Cantaloupe Cup" in 12 oz. plastic
cups, "Cantaloupe Chunks" in 8 oz. plastic cups. Recall
# F-224-4;
c) Cut fruit consisting of honeydew melon, cantaloupe,
seedless watermelon. Product may be identified as
"Fruit Medley" in 8 oz. plastic cups, "Melon Medley" in
8 oz, 16 oz. or 40 oz. plastic cups, "Cut Fruit Tray
Loose" in 64 oz. plastic tray, "Melon Wedge Combo" in 1
lb. plastic bag. Recall # F-225-4;
d) Cut fruit consisting of cantaloupe, honeydew, pineapple,
seedless watermelon, strawberry Product identified in
one of the following ways: "Fruit Tray" in 3.25 lb.
and 5 lb. plastic trays. Recall # F-226-4;
e) Cut fruit consisting of cantaloupe, honeydew melon,
grapes. Product identified in one of the following ways:
"Fresh Fruit Cup" in 12 oz. plastic cup, and "Bulk Cut
Fruit" in 8 lb. plastic bags. Recall # F-227-4;
f) Cut fruit consisting of cantaloupe, honeydew, pineapple,
red seedless grapes, orange segments Product identified
"Mixed Fruit" in 8 oz., 16 oz. or 40 oz. plastic cups.
Recall # F-228-4;
g) Cut fruit consisting of cantaloupe, honeydew, pineapple,
strawberries. Product identified in one of the following
ways: "Fresh Fruit Tray" in 64 oz. plastic tray, "Fresh
Fruit Medley" in 28 oz. plastic cup. Recall # F-229-4;
h) Cut fruit consisting of cantaloupe, honeydew melon,
grapes, strawberries. Product identified as "Fresh Fruit
Salad" in 56 oz. plastic cup. Recall # F230-4;
i) Cut fruit consisting of cantaloupe, honeydew, pineapple,
strawberries, seedless red grapes. Product identified as
"Recipe #2" in 8 lb. plastic bags. Recall # F-231-4;
j) Cut fruit consisting of cantaloupe, honeydew, pineapple,
seedless watermelon. Product identified as "Fruit Tray"
in 64 oz. plastic tray. Recall # F-232-4;
k) Cut fruit consisting of cantaloupe, honeydew, pineapple,
seedless watermelon, seedless red grapes. Product
identified as "Fruit Salad Kit" in 10 lb. plastic bags.
Recall # F-233-4;
l) Cut fruit consisting of watermelon, honeydew,
cantaloupe, grape. Product identified as "Melon Grape"
in 8 oz. and 40 oz. plastic cups and 1 lb. plastic bags.
Recall # F-234-4;
m) Cut fruit consisting of cantaloupe, blueberries,
strawberries. Product identified as "Cantaloupe Boat, 1
ct" in plastic bag. Recall # F-235-4.
CODE
Sale by 07/21/03 or before.
RECALLING FIRM/MANUFACTURER
Duck Delivery Produce Inc., Portland, OR, by telephone on July 15, 2003. Washington State initiated recall is complete.
REASON
Product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Approx. 220,000 lbs.
DISTRIBUTION
WA, OR, and ID.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Redbird Assorted Puffs Wrapped Bulk Candy, packaged in 5
lb bags, Item #2070. Recall # F-204-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
BA Sweetie Candy Co, Cleveland, OH, by telephone and letter on March 22, 2004. FDA initiated recall is ongoing.
REASON
The product contains undeclared FD&C colors Yellow #5 and Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
159 bags.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Manischewitz Apple Juice, 32 oz glass bottles. Pasteurized.
Recall # F-206-4.
CODE
Lot 2885.
RECALLING FIRM/MANUFACTURER
The B. Manischewitz Co LLC, Jersey City, NJ, by letters on March 25, 2004. FDA initiated recall is ongoing.
REASON
Apple Juice may contain Patulin in excess of 50 ppb.
VOLUME OF PRODUCT IN COMMERCE
553 cases of 12.
DISTRIBUTION
Nationwide, Mexico, and New Zealand.

_______________________________
PRODUCT
Great Skott Foods Super Energy Mix, Net Wt. 14 oz. packaged
in clear-plastic bags. Recall # F-236-4.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Great Skott Foods, Inc., Milwaukee, WI, by telephone on March 16, 2004, and by letters on March 18, 2004. Firm initiated recall is ongoing.
REASON
The product contains redskin peanuts. The ingredient list identifies the peanuts as "redskins". The word peanut is not mentioned anywhere on the label.
VOLUME OF PRODUCT IN COMMERCE
1,560 cases (6 units/case).
DISTRIBUTION
IL, MA, and WI.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

_______________________________
PRODUCT
MINI EPHEDRINE Tablets, Bronchodilator and Expectorant,
Each tablet contains 12.5 mg Ephedrine HCl, 200 mg
Guaifenesin, 6 tablets per packet, Over-the-Counter.
Recall # D-174-4.
CODE
3L001, Exp. 11/05.
RECALLING FIRM/MANUFACTURER
Ultra-Seal Corporation, New Paltz, NY, by telephone on February 9, and 10, 2004. Firm initiated recall is complete.
REASON
Mispacked: 25 mg ephedrine HC1/200 mg guaifenesin tablets were repacked into packets labeled as containing 12.5 mg ephedrine HC1/200 mg guaifenesin tablets.
VOLUME OF PRODUCT IN COMMERCE
308,832 packets.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
VisiClear Sterile Eye Drops (methyl cellulose 0.3% and
glycerin 1.3%), 2 ml tubes, packaged in 4 count boxes,
over-the-counter, NDC# 65650-017-09. Recall # D-171-4.
CODE
3081902/30600.
RECALLING FIRM/MANUFACTURER
Tri Medica, Inc., Tempe, AZ, by fax, telephone and e-mail on April 20, 2004 and by letters on April 23, 2004. FDA initiated recall is ongoing.
REASON
Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE
23,569 ampules.
DISTRIBUTION
Nationwide, Barbados, and Great Britain.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
OxyContin" 20 mg (oxycodone HCL, controlled release)
Tablets, 100 count bottles, Rx Only. NDC 59011-103-10.
Recall # D-172-4.
CODE
Lot No. WS031, Expiration date: 09/30/06.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, by letters on April 22, 23 & 26, 2004. Firm initiated recall is ongoing.
REASON
Tablet mixup; bottle labeled as OxyContin" 20 mg tablets contained OxyContin" 20 mg tablets and one OxyContin" 10 mg tablet.
VOLUME OF PRODUCT IN COMMERCE
15,428/100 count bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Premarin (conjugated estrogens tablets, USP), 0.625 mg, 100
and 1000 count bottles, Rx only. NDC 0046-0867-91 (1000s),
NDC 0046-0867-81 (100s). Recall # D-173-4.
CODE
Lot Numbers: 021372A (1000s); 021372B and 021372C (100s). Exp. Date: SEP 30 04.
RECALLING FIRM/MANUFACTURER
Amerisource Health Services Corp, Columbus, OH, by letters and fax on May 11, 2004. Firm initiated recall is ongoing.
REASON
Failure to meet USP dissolution specifications by manufacturer.
VOLUME OF PRODUCT IN COMMERCE
23,039 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-1302-4.
CODE
Units FJQYFY, FJQYLZ.
RECALLING FIRM/MANUFACTURER
Aventis Bio Services, Roanoke, VA, by letter dated October 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1313-4;
b) Platelets. Recall # B-1314-4;
c) Fresh Frozen Plasma. Recall # B-1315-4;
d) Cryoprecipitated AHF. Recall # B-1316-4;
e) Recovered Plasma. Recall # B-1317-4.
CODE
a) Unit numbers: FL09540, FL09539, GE63466, FT06502,
FS53238, GP59472, KG97136, GV55730, GE63793, KJ60095,
KH47496, KC75435;
b) Unit numbers: GV55730, KJ60095, FT06502;
c) Unit numbers: GV55730, KJ60095;
d) Unit numbers: KH47496, KC75435;
e) Unit numbers: GE63466, FT06502, FS53238, GP59472,
KH47496, KC75435.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on September 2, 2003, and by facsimile on September 3, 2003. Firm initiated recall is complete.
REASON
Blood products, collected using a phlebotomy method that may have compromised the sterility of the products were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1341-4.
CODE
Unit number: 3202505.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by telephone on December 21, 2001. Firm initiated recall is complete.
REASON
Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-1342-4.
CODE
Unit numbers: 18FS78428 (2 parts).
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing, MI, by letter and facsimile, dated March 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not have a hematocrit value performed during the donor screening process, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-1354-4;
b) Recovered Plasma. Recall # B-1355-4.
CODE
a) and b) Unit S74864.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw Valley, Saginaw, MI, by facsimile on March 5, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI and Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1356-4.
CODE
Unit 11333-6706.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on August 12, 2002. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving information concerning a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NM.
_____________________________
PRODUCT
a) Platelets. Recall # B-1366-4;
b) Fresh Frozen Plasma. Recall # B-1367-4.
CODE
a) and b) K64301.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on December 31, 2003. Firm initiated recall is complete.
REASON
Blood Products, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets. Recall # B-1368-4.
CODE
Unit numbers: K82663 and K85159.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on December 30, 2003. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets. Recall # B-1369-4.
CODE
Unit number: T79712.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on December 29, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets. Recall # B-1370-4.
CODE
Unit numbers: K85379.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on December 31, 2003, and by letter on January 26, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1371-4.
CODE
Unit number K96664.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on February 10, 2004, and by letter on March 4, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1340-4.
CODE
Unit number: 18GC17339.
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing, MI, by telephone on March 11, 2004, and by letter, dated March 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking an antibiotic, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1373-4.
CODE
Unit number: 16LV94600.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on March 15, 2004, and by letter dated March 18, 2004. Firm initiated recall is complete.
REASON
Blood product, with an unacceptable hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1374-4.
CODE
Unit numbers: 40FE79800, 40FT17003.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of American Blood Services Region, Peoria, IL, by telephone on March 4, 2004 and by letter dated March 12, 2004. Firm initiated recall is complete.
REASON
Blood products, with unacceptable hematocrits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm).
Reorder No. 3607. Sterile with non-stick pad. 100% Latex
Free Bandage & Wrapper. 48 boxes of 100 bandages per case.
Device Listing # E177598.510 (k) Exempt. Recall # Z-0951-
04.
CODE
Lot Number 15860.
RECALLING FIRM/MANUFACTURER
Dynarex Corp., Orangeburg, NY, by letters on May 10, 2004. FDA initiated recall is ongoing.
REASON
Bandages labeled as "100% Latex Free" may contain latex. The wrapper was analytically tested by a private laboratory and found to contain latex.
VOLUME OF PRODUCT IN COMMERCE
50 cases.
DISTRIBUTION
Nationwide, and Puerto Rico.

_______________________________
PRODUCT
a) Auto Suture TA 30 Reloadable Staplers, Single Patient
Use Ref TA30V3S, V3 (2.5mm) DST Series. Recall # Z-
0958-04;
b) Auto SutureTA 30 Reloadable Stapler, Single Patient
Use, 3.5mm DST Series Ref: TA3035S. Recall # Z-0959-04;
c) Auto SutureTA 30 Reloadable Stapler, Single Patient Use,
4.8mm DST Series Ref: TA30348S. Recall # Z-0960-04;
d) Auto SutureTA 45 Reloadable Stapler,Single Patient Use,
3.5mm DST Series Ref: TA4535S. Recall # Z-0961-04;
e) Auto SutureTA 45 Reloadable Stapler,Single Patient Use,
4.8mm DST Series Ref: TA4548S. Recall # Z-0962-04.
f) Auto SutureTA 60 Reloadable Stapler,Single Patient Use,
3.5mm DST Series Ref: TA6035S. Recall # Z-0963-04;
g) Auto SutureTA 60 Reloadable Stapler,Single Patient Use,
4.8mm DST Series Ref: TA6048S. Recall # Z-0964-04;
h) Auto SutureTA 90 Reloadable Stapler,Single Patient Use,
3.5mm DST Series Ref: TA9035S. Recall # Z-0965-04;
i) Auto SutureTA 90 Reloadable Stapler,Single Patient Use,
4.8mm DST Series Ref: TA9048S. Recall # Z-0966-04.
CODE
a) LOT# P2J507 P2J972 P2K1034 P2K616 P2L334 P2L335 P2L607
P2M694 P2M695 P3A83 P3B307 P3D245 P3D564 P3E236 P3E309
P3F683 P3G300 P3G855 P3H21 P3J263 P3J408 P3J42 P3K13
P3L1011 P3L1012 P3L1133 P3L1134 P3L13 P3L237 P3L447
P3L628 P3L728 P3M558 P3M668 P4A636 P4B176 U2H11 U2H17
U2J01 U2J02;
b) LOT# P2J505 P2J971 P2K1031 P2K813 P2L332 P2L603 P2L604
P2M227 P2M228 P2M235 P2M82 P3A1151 P3A323 P3A443 P3A908
P3B336 P3B607 P3C710 P3C802 P3D563 P3D944 P3E233 P3E294
P3G08 P3G09 P3G417 P3G621 P3G769 P3H288 P3H638 P3J41
P3J456 P3K05 P3K06 P3K07 P3K08 P3L1007 P3L1008 P3L11
P3L1129 P3L1130 P3L12 P3L243 P3L42 P3L425 P3L440 P3L441
P3M368 P3M369 P4A634 P4A881 U2H02 U2H08;
c) LOT# P2J506 P2J508 P2K1032 P2K186 P2K614 P2L333 P2M236
P2M549 P2M550 P2M703 P3A1149 P3A1150 P3A453 P3B340
P3C803 P3D86 P3E234 P3E296 P3G10 P3H287 P3H639 P3J245
P3J458 P3K10 P3K11 P3L1009 P3L1010 P3L1131 P3L1132
P3L233 P3L234 P3L43 P3L443 P3L445 P3L446 P3L727 P3L87
P3M366 P3M367 P3M550 P4B161 U2H01 U2H09;
d) LOT# P2J450 P2J795 P2J796 P2J797 P2J798 P2L657 P2M193
P2M241 P2M542 P2M98 P3A412 P3A91 P3A92 P3A93 P3B345
P3B608 P3B609 P3B610 P3C238 P3D246 P3D568 P3D947 P3E237
P3E300 P3E523 P3F113 P3F684 P3G960 P3J237 P3J43 P3J44
P3J459 P3J711 P3K15 P3L1135 P3L1136 P3L1152 P3L235
P3L236 P3L448 P3L449 P3L629 P3L997 P3L998 P3M672 P3M673
P4A554 P4A637 P4A883 P4B585 U2E11 U2F13 U2F17 U2G02
U2G03 U2G11 U2G13;
e) LOT# P2H776 P2J263 P2J607 P2J792 P2J793 P2L647 P2L648
P2M243 P2M244 P2M552 P3A118 P3A413 P3A909 P3B341 P3B342
P3B343 P3B344 P3B611 P3B848 P3C239 P3C241 P3C437 P3C439
P3C588 P3E18 P3E238 P3E301 P3E524 P3E525 P3E647 P3F115
P3F225 P3F352 P3F446 P3H252 P3H280 P3H404 P3H431 P3H432
P3H640 P3H641 P3J45 P3J46 P3J47 P3J712 P3J713 P3K20
P3L1004 P3L1005 P3L1006 P3L1138 P3L1139 P3L238 P3L239
P3L450 P3L630 P3L631 LOT# P3L729 P3M464 P4A126 P4A128
P4A336 P4A337 P4A338 P4A544 P4A549 P4A884 P4A885 P4B242
P4B587 P4B710 U2E10 U2E12 U2F02 U2F16 U2F20 U2G04 U2G06
U2G09;
f) LOT# P2G906 P2G907 P2G908 P2J239 P2J239A P2J451 P2J559
P2K1053 P2K1054 P2K1055 P2K334 P2K617 P2L129 P2L130
P2L131 P2L651 P2L652 P2L653 P2L654 P2M194 P2M195 P3A119
P3A120 P3A121 P3A415 P3A416 P3A417 P3A646 P3A910 P3B33
P3B34 P3C627 P3C738 P3D249 P3D251 P3D252 P3D571 P3D572
P3D582 P3D583 P3F464 P3F465 P3F466 P3F467 P3F685 P3G195
P3G196 P3G197 P3G766 P3G871 P3H248 P3H250 P3J460 P3J48
P3J49 P3J50 P3J719 P3K22 P3K23 P3K24 P3K25 P3K358 P3K359
P3L1000 P3L1001 P3L1002 P3L1003 P3L1144 P3L1145 P3L1146
P3L1148 P3L225 P3L226 P3L227 P3L228 P3L452 P3L453 P3L454
P3L455 P3L456 P3L633 P3L634 P3L635 P3L636 P3L637 P3L999
P3M551 P4A130 P4A133 P4A135 P4A560 P4A641 P4A888 P4B243
P4B267 U2F03 U2F07 U2F12 U2F27;
g) LOT # P2H15 P2J240 P2J240A P2J265 P2J784 P2J786 P2K827
P2L124 P2L655 P2L656 P2M96 P3A418 P3A648 P3A940 P3A98
P3C01 P3C423 P3C626 P3D21 P3D280 P3D584 P3D951 P3F468
P3G914 P3H249 P3H444R P3H566 P3J238 P3J462 P3J463
P3L1149 P3L1150 P3L229 P3L230 P3L240 P3L241 P3L458
P3L459 P3L460 P3L638 P3L730 P3L994 P3L995 P3L996 P4A138
P4A889 P4B270 P4B591 P4B714 P4B716 U2E13R U2F08 U2F28
U2F30;
h) LOT# P2H679 P2J642 P2K1113 P2K534 P2K66 P2L609 P2L610
P2L611 P2L649 P2M692 P3A650 P3C425 P3C800 P3E304 P3F686
P3G15 P3G414 P3J249 P3J250 P3J256 P3L1013 P3L1141 P3L242
P3L44 P3L462 P3L639 P4A547 P4A642 P4A890 P4B727 U2G21;
i) LOT# P2H677 P2H678 P2J787 P2J788 P2L645 P2L646 P2L650
P2M226 P2M693 P3A652 P3B308 P3B613 P3C426 P3C432 P3C819
P3D953 P3E649 P3F116 P3F841 P3G16 P3G17 P3H281 P3H282
P3H447 P3H448 P3K27 P3K362 P3L1014 P3L1015 P3L1142
P3L231 P3L232 P3L45 P3L464 P3L465 P3L466 P3L731 P4A546
P4A643 P4A891 U2G15;
RECALLING FIRM/MANUFACTURER
United States Surgical, North Haven, CT, by letter dated May 5, 2004. Firm initiated recall is ongoing.
REASON
Stapler may clamp without the staples being fired into the tissue.
VOLUME OF PRODUCT IN COMMERCE
195,690 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used
with a Model 7900 Ventilator, on a Aestiva/5 Anesthesia
Machine. Recall # Z-0967-04;
b) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System,
used with a Model 7100 Ventilator, on a Aestiva/5
Anesthesia Machine. Recall # Z-0968-04;
c) Datex-Ohmeda Aestiva/5 Active Gas Scavenging System,
used with a Model 7900 Ventilator, on a Aestiva/5
Anesthesia Machine, in a Magnetic Reasonance Suite.
Recall # Z-0969-04.
CODE
a) Serial numbers AMRG02807, AMRG02889 thru AMRG02899,
AMRG02930, AMRG02937 thru AMRG02942, AMRG02955,
AMRG02958, AMRG02967, AMRG02968, AMRG02969, AMRG02979
thru AMRG03005, AMRG03012 thru AMRG03014, AMRG03017,
AMRG03018, AMRG03030, AMRG03057 thru AMRG03062,
AMRG03072, AMRG03077, AMRG03080, AMRG03081, AMRG03084,
thru AMRG03088, AMRG03115, AMRG03155, AMRG03156,
AMRG03174, AMRG03180 thru AMRG03185, AMRG03198,
AMRG03199, AMRG03201, AMRG03208, AMRG03209, AMRG03212
thru AMRG03215, AMRG03222 thru AMRG03224, AMRG03261 thru
AMRG03270, AMRG03298 thru AMRG03306, AMRG03331 thru
AMRG03347, AMRG03351 thru AMRG03353, AMRH00124, thru
AMRH00140, AMRH00143, AMRH00151, AMRH00152, AMRH00163,
AMRH00169, AMRH00169, AMRH00170, AMRH00174 thru
AMRH00181, AMRH00184, AMRH00185, AMRH00190 thru
AMRH00202, AMRH00232 thru AMRH00237, AMRH00243,
AMRH00244, AMRH00246, AMRH00247, AMRH00259, thru
AMRH00276, AMRH00290 thru AMRH00307, AMRH00309, thru
AMRH00311, AMRH00328, AMRH00329, AMRH00363 thru
AMRH00368, AMRH00376, AMRH00382, thru AMRH00387,
AMRH00396 thru AMRH00399, AMRH00399, AMRH00429,
AMRH00430, AMRH00433, thru AMRH00439, AMRH00445 thru
AMRH00464, AMRH00468, AMRH00469, AMRH00472 thru
AMRH00474, AMRH00497 thru AMRH00502, AMRH00511 thru
AMRH00513, AMRH00538 AMRH00543, AMRH00561 thru AMRH00571
thru AMRH00587, AMRH00589 thru AMRH00591, AMRH00594,
AMRH00597 thru AMRH00603, AMRH00605 thru AMRH00626,
AMRH00628 thru AMRH00636, AMRH00651, AMRH00652,
AMRH00655 thru AMRH00657, AMRH00659 thruAMRH00661,
AMRH00663 thru AMRH00669, AMRH00671, AMRH00672,
AMRH00674 thru AMRH00676, AMRH00682, AMRH00684, and
AMRH00704 thru AMRH00717;
b) Serial numbers AMVG01045, AMVG01047, AMVG01052,
AMVG01062, AMVG01072 thru AMVG01083, AMVH00100 thru
AMVH00109, AMVH00116, AMVH00125, AMVH00126, AMVH00129,
AMVH00132, AMVH00133, AMVH00139, AMVH00141 thru
AMVH00148, AMVH00151 thru AMVH00154, AMVH00159,
AMVH00160, AMVH00164, AMVH00166, AMVH00159, AMVH00160,
AMVH00164, AMVH00166, AMVH00171 thru AMVH00186,
AMVH00195 thru AMVH00198, AMVH00211, and AMVH00228 thru
AMVH00230;
c) Serial numbers AMTG00208, AMTG00212, AMTG00213,
AMTG00216, AMTG00219, AMTG00220, AMTG00222, AMTH00113,
AMTH00121, and AMTH00124.
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Inc., Madison, WI, by letters dated April 26, 2004. Firm initiated recall is ongoing.
REASON
Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.
VOLUME OF PRODUCT IN COMMERCE
466 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
DC Power Adapter for use with the LIFEPAK 12
defibrillator/monitor. Part numbers: VLP12-09-000031
through VLP12-09-000047. Recall # Z-0971-04.
CODE
Serial numbers: 1563 through 5232 (non-contiguous).
RECALLING FIRM/MANUFACTURER
Medtronic Physio Control Corp., Redmond, WA, by letter on May 5, 2004. Firm initiated recall is ongoing.
REASON
The DC Power Adapter may fail to charge LIFEPAK NiCd 2.4 AH batteries used with the LIFEPAK 12 defibrillator/monitor.
VOLUME OF PRODUCT IN COMMERCE
1,689.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Immulite 1000 CEA. Catalog No. LKCE1. Recall # Z-0972-04.
CODE
Lots 5 157 and 5 157L.
RECALLING FIRM/MANUFACTURER
Diagnostic Products Corp., Los Angeles, CA, by e-mail or telephone on May 3, 2001.
REASON
Instability. Controls tend to run high of their target range.
VOLUME OF PRODUCT IN COMMERCE
884.
DISTRIBUTION
Nationwide and worldwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
MicroSTAAR Injector, MSI-PF Packed ten per box. Recall #
Z-0957-04.
CODE
Lot 1186591 Expires 12/31/06, Lot 1186692 Expires 12/31/06.
RECALLING FIRM/MANUFACTURER
Staar Surgical Co., Inc., Monrovia, CA, by company representatives visits beginning on April 21, 2004.
REASON
Cracking of the distal end of the injector occurs during locking of the cartridge into the nose cone of the injector.
VOLUME OF PRODUCT IN COMMERCE
124 boxes, 10 per box.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR MAY 26, 2004

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