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.

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February 9, 2005
05-06

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
SL Technology brand Kondita biscuits, Sponge Biscuit with Cherry Jelly & Chocolate, 125 g (4.41 oz.) --- Ingredients: sugar, wheat flour, chocolate icing, glucose syrup, vegetable fat, powdered eggs, whey powder, pectin-jelly formation, dough raising (ammonium bicarbonate, natrium bicarbonate), emulsifying agent (E 322, E 476), citric acid, acidity regulator (sodium citrate), naturally identical aroma, color E124. Chocolate mass contains: min. 47% dry matter cocoa portions. --- Best before the date impressed on the cover. Recall # F-171-5.
CODE
"Best Before Date 02 02 2005" imprinted on side of box.
RECALLING FIRM/MANUFACTURER
Dalston New York, Inc., Astoria, NY, by telephone on September 30, 2004, and by letters dated October 1, 2004. Firm initiated recall is ongoing.
REASON
Ingredient statement of product lists E124 (Ponceau 4R), an unapproved color additive.
VOLUME OF PRODUCT IN COMMERCE
45 cases (24 - 125 gram boxes per case).
DISTRIBUTION
NY, GA, and FL.

_______________________________
PRODUCT
a) Product is a powdered concentrate that is
designed to be mixed with water or milk.
Packed in a gray plastic bottle and is labeled
as MYO MAX, Scitec Nutrition the ultimate
engineered anabolic MRP formula. Laboratory
tested Dietary Supplement. All In One Formula,
Raspberry cream, French Vanilla Delight and
Double Dutch Chocolate Flavors. Net Wt 2.91 Lbs,
Meal replacement powder. Recall # F-172-5;
b) Product is a powdered concentrate that is
designed to be mixed with water or milk.
Packed in a gray plastic bottle and is labeled
as MYO MAX Gain + Ultrapure Aminogen, High
Protein performance support formula. Raspberry
Cream, French Vanilla Delight, Double Dutch
Chocolate and Strawberry Cream flavors.
Laboratory tested Dietary Supplement. Highest
quality whey protein only, Net Wt 3.6 Lbs,
Each 4 scoop serving of MyoMax Gain provides
50% of the RDA vitamin intake. Recall # F-173-5;
c) Product is a powdered concentrate that is
designed to be mixed with water or milk.
Packed in a gray plastic bottle. His and Her
Low-Calorie High-Protein formula. Raspberry
Cream, French Vanilla Delight, Double Dutch
Chocolate and Strawberry Cream flavors.
Laboratory tested Dietary Supplement. Support
Fat Loss! Increase Muscularity! Essential for
a Lean Physique, Net Wt 3.43 Lbs, Each 4 scoop
serving of MyoMax Meal provides 50% of the
RDA vitamin intake. Recall # 174-5.
CODE
a) Lot numbers beginning with 0309, 0310, 0311,
0312, 0401, 0402, and 0403;
b) Lot numbers beginning with 0309, 0310, 0311,
0312, 0401, 0402, and 0403;
c) Lot numbers beginning with 0309, 0310, 0311,
0312, 0401, 0402, and 0403.
RECALLING FIRM/MANUFACTURER
Advanced Nutritional Biosystems, Inc., Orlando, FL, by letters beginning April 19, 2004, and by telephone on April 22, 2004. Firm initiated recall is ongoing.
REASON
Dietary supplements/meal replacements are subpotent.
VOLUME OF PRODUCT IN COMMERCE
16,429 bottles.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Hickory Smoked Atlantic Salmon Sides in various sized consumer packages. Recall # F-175-5.
CODE
Code 7848, Lot 406250.
RECALLING FIRM/MANUFACTURER
House of Smoke, Inc., Fort Lupton, CO, by telephone on July 7, 2004. Firm initiated recall is complete.
REASON
Smoked salmon had low water phase salt and was produced in a facility that had deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR 123.
VOLUME OF PRODUCT IN COMMERCE
89 pounds.
DISTRIBUTION
CO.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
a) Lafayette Baro-Cat Barium Sulfate Suspension
USP, 1.5% w/w (w/v) barium sulfate, USP, Net
Contents: 300mL, 900mL and 1900mL bottles,
Rx only, Distributed in Canada by: Tyco
Healthcare, Montreal Quebec, Canada, Made
in Mexico. Recall # D-084-5;
b) Lafayette Cheetah Barium Sulfate Suspension,
2.2% w/w barium sulfate USP, Net Contents: 250mL,
450mL, 900mL, and 1900mL bottles, Rx only. Made
in Mexico. Recall A# D-085-5;
c) NovaPlus Colon Barium - Air Contrast Barium
Sulfate Suspension, 100% w/v (55% w/w) barium
sulfate USP, Net Contents: 1900mL bottles,
Rx only, Made in Mexico. Recall # D-086-5;
d) NovaPlus CT Barium Sulfate Suspension, 1.5%
w/w (w/v) barium sulfate, Net Contents: 450mL
bottles, For Computed Tomography, Rx only,
Made in Mexico. Recall # D-087-5;
e) NovaPlus CT Barium-Fast Transit Barium
Sulfate Suspension, 2.2% w/w barium sulfate
USP, For Computed Tomography, Net Contents:
450mL bottles, Rx only, Made in Mexico.
Recall # D-088-5;
f) Lafayette Entrobar Barium Sulfate Suspension,
50% w/v barium sulfate suspension, Net Contents:
500mL bottles, Rx only. Recall # D-089-5;
g) Lafayette Entrocel Methylcellulose Solution,
1.5% w/w hydroxypropyl methylcellulose solution,
Net Contents: 500mL bottles, Rx only, Made in
Mexico. Recall # D-090-5;
h) Lafayette Entro-Ease Barium Sulfate Suspension,
15% w/v (12% w/w) barium sulfate, Net Contents:
600mL bottles, Rx only, Made in Mexico.
Recall # D-091-5;
i) Lafayette Entro-Ease Barium Sulfate Suspension,
15% w/v (12% w/w) barium sulfate, Net Contents:
600mL bottles, Rx only, Made in Mexico.
Recall # D-091-5;
j) Lafayette Liqui-Coat HD Barium Sulfate
Suspension, 210% w/v (81% w/w) barium sulfate,
Net Contents: 150 mL unit dose bottles, Rx only,
Made in Mexico. Recall # D-092-5;
k) Lafayette Liquid Barosperse Barium Sulfate
Suspension, 60%w/v barium sulfate, Net
Content: 355mL and 1900mL bottles, Rx only,
Made in Mexico. Recall # D-093-5;
l) Lafayette Flo-Coat Barium Sulfate Suspension,
100% w/v (55% (w/w) suspension of barium
sulfate USP, Net Contents: 1850mL, Rx only.
Recall # D-094-5;
m) HD 85 Barium Sulfate Suspension, 85% w/v
suspension of barium sulfate USP, Net
Contents: 1900 mL bottles, Rx only.
Recall # D-095-5;
n) Medebar Plus Barium Sulfate Suspension,
100% w/v suspension of barium sulfate USP,
Net Content: 650mL and 1900mL bottles, Rx only.
Recall # D-096-5;
o) Medescan Barium Sulfate Suspension USP,
2.2% w/w (2.3% w/v), Net Content: 250mL,
450mL and 1900mL bottles, Rx only.
Recall # D-097-5;
p) Prepcat Barium Sulfate Suspension, 1.5% w/w
(w/v) barium sulfate USP, Net Contents: 450mL
bottles, For Computed Tomography, Rx only.
Made in Mexico, Recall # D-098-5;
q) Lafayette Entrokit Enteroclysis Kit with
Catheter, Kit contains: Reglan (metoclopramide
hydrochloride) 10mg (metoclopramide base)
Tablets, 2% lidocaine hydrochloride, viscous
solution, Entrobar 50% w/v barium sulfate
suspension, Entrocel methylcellulose solution.
Recall # D-099-5;
r) Lafayette Intropaste Barium Sulfate Paste,
(barium sulfate, USP), 70% w/v (44% w/w),454
gm tubes, Rx only, Made in Mexico.
Recall # D-100-5;
s) Entrokit Enteroclysis Kit, Contents: Drugs:
Rx only, Reglan, metoclopramide hydrochloride,
10mg (metoclopramide base) tablets, 2%
Xylocaine, lidocaine hydrochloride, viscous
solution, Entrobar, 50% w/v barium sulfate
suspension, Entrocel, methylcellulose solution
concentrate. Recall # D-101-5;
t) Novaplus Liquid Barium - Single Contrast Barium
Sulfate Suspension, 50% w/v barium sulfate USP,
1900 mL bottles, Rx Only, Made in Mexico.
Recall # D-102-5;
u) Scan C Barium Sulfate Suspension, 2.1% w/w for
computed tomography (CT) exams, 250 mL bottle,
Preservative Free, Rx only. Recall # D-103-5;
v) EVACU-PASTE 100, Barium Sulfate Paste
(100% w/v,56%w/w), Contents: 12 x 454 g
Cartridges, 12 Tip Assemblies and 1 Cutter,
Rx Only. Recall # D-109-5.
CODE
a) Lot Numbers: 300mL: 409316, 411485, 411486,
411489 -- 900mL: 406112 - 406114, 409313 -
409315, 409321- 409349, 410429, 410435, 411487,
411488, 411490 -- 1900mL: 407203, 409350;
b) Lot Numbers: 250mL: 031145 - 031147, 406102,
407148, 410378, 410416, 411465, 411466 -
450mL: 031145 - 031147, 040318 - 040340,
040430 - 040441, 040477, 040549 - 040551,
406029 - 406034, 407132 - 407137, 408269,
408271 - 408282, 408292, 408293, 409303,
409304, 409356 - 409358, 410369 - 410373,
410391, 410404, 401420 - 410427, 411467 -
411474 -- 900mL: 031145 - 031147, 040424 -
040429, 406035, 406036, 406103 - 406105,
407149, 409363 - 409365, 410374 - 410377,
410428 -- 1900mL: 031145 - 031147, 410379,
410380, 411475, 412612;
c) Lot Numbers: 040456, 410384;
d) Lot Numbers: 040542, 040543, 409320;
e) Lot Numbers: 040541, 040574, 040575, 406083 -
406086, 410383, 410432 - 410434;
f) Lot Numbers: 040115 - 040117, 410381, 410382,
412615, 412616;
g) Lot Numbers: 040119 - 040121, 406092;
h) Lot Numbers: 031026, 031027, 031028, 040442,
040443, 406093, 407205, 407206, 411464, 411484,
412581, 412587;
i) Lot Numbers: 031263 - 031265, 040578 - 040581,
407180 - 407182, 411437, 412565, 412624, 412625;
j) Lot Numbers: 355mL: 040582, 040583, 406037,
407192, 407193, 407216, 410381, 412562, 412566,
412567 -- 1900mL: 040584, 040585, 406051,
407189 - 407191, 407217, 411440, 412563;
k) Lot Numbers: 031033, 031034, 031035, 031037,
407150 - 407154, 410414, 410415, 411443, 411444,
411498 - 411500;
l) Lot Numbers: 410400, 412611;
m) Lot Numbers: 650mL: 031138, 031139, 031252,
040576, 040577, 406014, 406100, 406101, 410402,
410403 -- 1900mL: 031255 - 031257, 040341,
040342, 407171 - 407173;
n) Lot Numbers: 250mL: 407204, 410398, 412626 -
450mL: 040373 - 040375, 040463 - 040465, 040480,
040544 - 040548, 406024 - 406028, 407126, 407127,
407220, 409343 - 409346, 410390, 410396, 410397,
411491 - 411494, 412582 - 412585 -
1900mL: 410399, 412586;
o) Lot Numbers: 405002 - 405006, 406053 - 406056,
409317 - 409319, 409336-409338, 410386 - 410389,
410412 - 410413, 412613, 412614;
p) Lot Number: 040804-01;
q) Lot Numbers: 030614-1 - 030616-8, 040388-1 -
040562-8, 406081 - 409335-8;
r) Lot Numbers: 040511-01, 041111-01;
s) Lot Numbers: 506052, 512564, 512658;
t) Lot Numbers: 030717-1 - 031267-4, 040122 - 040125,
040234-1 - 040540-4, 406087-1 - 411462-1;
u) Lot Numbers: 406065-1 through 406076-4.
RECALLING FIRM/MANUFACTURER
Kendall Healthcare Products Co, Mansfield, MA, by letter on December 17, 2004. Firm initiated recall is ongoing.
REASON
Microbial contamination; product may be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
165,000 cases or 2.2 million units.
DISTRIBUTION
Nationwide and Internationally.
______________________________
PRODUCT
Carboplatin Injection, Each mL contains 10mg carboplatin and water for Injection, 50 mg/5 mL (10 mg/ml), 5mL Single Dose Vial, For IV Infusion. NDC 55390-220-01. Recall # D-113-5.
CODE
Lot #589490B.
RECALLING FIRM/MANUFACTURER
Bedford Laboratories, Bedford, OH, by telephone on November 29, 2004. Firm initiated recall is ongoing.
REASON
Mispacked; outer carton labeled as Carboplatin Injection 50mg/5mL vial actually contains Carboplatin Injection 150mg/15mL vial.
VOLUME OF PRODUCT IN COMMERCE
60 vials.
DISTRIBUTION
IL, OH, NJ, MI, MO, MN, and WA.

_______________________________
PRODUCT
Paxil Tablets (paroxetine hydrochloride), 10mg scored tablets, 30 count bottles, Rx only. NDC 0029-3210-13. Recall # D-116-5.
CODE
Lot Number: F61-4B10; Expiration date: 31 July 2006.
RECALLING FIRM/MANUFACTURER
Sb Pharmco Puerto Rico Inc., Cidra, PR, by letter dated December 17, 2004. Firm initiated recall is ongoing.
REASON
Subpotent; 3 month stability.
VOLUME OF PRODUCT IN COMMERCE
78,000 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Desyrel Dividose Tablets (tranzodone HCL) 150 mg, 100 count bottle, Rx only. NDC 0087-0778-43. Recall # D-112-5.
CODE
Lot # 4F83245, Exp. date 6/30/2007.
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Manufacturing Co, Mayaguez, PR, by letter on November 8, 2004. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice Deviation; Quarantine drum of active ingredient was inadvertently used for production.
VOLUME OF PRODUCT IN COMMERCE
242 bottles/100 tablets.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Source Plasma. Recall # B-0211-5.
CODE
Units: F-22778-011, F-27249-011, F-27788-011, F-28189-011, F-29064-011, F-29389-011, F-30075-011, F-30763-011, F-31180-011, F-31764-011, F-32149-011, F-34888-011, F-35337-011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by fax on June 13, 2003.
Manufacturer: Alpha Therapeutic Corporation, Portland, OR. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had body piercing within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0503-5;
b) Granulocytes, Platelets Pheresis.
Recall # B-0504-5;
c) Platelets. Recall B-0505-5;
d) Platelets Pheresis. Recall # B-0506-5;
e) Fresh Frozen Plasma. Recall # B-0507-5;
f) Cryoprecipitated AHF. Recall # B-0508-5;
g) Cryoprecipitated AHF, Pooled. Recall # B-0509-5;
h) Recovered Plasma. Recall # B-0510-5.
CODE
a) Unit numbers: 17G67521, 17KK11407, 17F97853,
17GK05376, 17GK90108, 17GK77844, 17GK57176,
17GK50110, 17GK36465, 17GK27539, 17G99751,
17H05783, and 17G57489;
b) Unit number: 17GS46051;
c) Unit numbers: 17GK05376, 17G67521, 17F97853,
and 17G57489;
d) Unit numbers: 17GS52818, 17GS54875, 17GS57714,
17S36475, 17S43147, 17S44939, and 17GS48667;
e) Unit number: 17F97853;
f) Unit number: 17G99751;
g) Unit number: 17GK36465;
h) Unit numbers: 17G67521, 17KK11407, 17G57489,
17GK27539, 17H057783, 17GK05376, 17GK90108,
17GK77844, 17GK57176, 17GH27257, 17GK36465,
and 17G99751.
RECALLING FIRM/MANUFACTURER
American Red Cross, North Central Region, St. Paul, MN, by facsimile or by letter, dated July 23, 1999. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibody to human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors that previously tested repeatedly reactive for anti-HIV-1, were distributed.
VOLUME OF PRODUCT IN COMMERCE
40 units.
DISTRIBUTION
CA, MN, WI, VA, NJ, GA, AR, SC, and MA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0529-5;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-0530-5;
c) Red Blood Cells, Pheresis, Leukocytes Reduced.
Recall # B-0531-5;
d) Recovered Plasma. Recall # B-0532-5.
CODE
a) Units 26117-2070, 26117-2071, 26117-2072,
26117-2073, 26117-2074, 26117-2075, 26117-2081,
26117-2082, 26117-2083, 26117-2088, 26117-2089,
26117-2090, 26117-2232, 26117-2234, 26117-2237,
26117-2238, 26117-2240, 26117-2242, 26117-6191,
26117-6192, 26117-6193, 26117-6194, 26117-6195,
26117-6196, 26117-6198, 26117-6600, 26117-6601,
26117-6602, 26117-6603, 26117-6605, 26117-6607,
26117-6608, 26117-6609, 26117-6802, 26117-6669,
26117-6670, 26117-6671, 26117-6672, 26117-6675,
26117-6676, 26117-6677, 26117-6678, 26117-6679,
26117-6680, 26117-6682;
b) Unit 26117-2244;
c) Units 26117-6615 (split 1 and split 2),
26117-6187;
d) Units 26117-2081, 26117-2082, 26117-2083,
26117-2088, 26117-2090, 26117-2234, 26117-2235,
26117-2236, 26117-2237, 26117-2238, 26117-2239,
26117-2240, 26117-2241, 26117-2242, 26117-2244,
26117-2279, 26117-2280, 26117-2281, 26117-6194,
26117-6195, 26117-6196, 26117-6602, 26117-6603,
26117-6605, 26117-6607, 26117-6608, 26117-6609,
26117-6679, 26117-6680, 26117-6682, 26117-6802,
26117-2071, 26117-2072, 26117-2073, 26117-2074,
26117-2075, 26117-2077, 26117-6191, 26117-6192,
26117-6193, 26117-6198, 26117-6600, 26117-6601,
26117-6669, 26117-6670, 26117-6671, 26117-6672,
26117-6675, 26117-6676, 26117-6677, 26117-6678.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Fort Smith, AR, by telephone on May 29, 2003 and May 30, 2003, by letter dated June 26, 2003, or by facsimile on June 18, 2003.
Manufacturing Firm: Blood Systems, Inc., Hot Springs, AR. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
100 units.
DISTRIBUTION
AR, CA, FL, MS, TX, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0537-5.
CODE
Unit 207253800.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ, by telephone on May 18, 2004.
Manufacturing Firm: Blood Systems, Inc., Lafayette, LA. 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
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0540-5.
CODE
Units 0786733, 0689361.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by telephone on April 25, 2002 and by letter dated May 6, 2002. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for Cytomegalovirus (CMV), but labeled as CMV negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Pheresis. Recall # B-0541-5.
CODE
Unit 33GC00532.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Framington, CT, by telephone and by letter dated October 15, 2004. Firm initiated recall is complete.
REASON
Blood product, which failed to meet specification for Red Blood Cell volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0569-5.
CODE
Unit numbers 20039-7973, 20039-4557, 20039-4515, 20039-4513, 20039-4542, 20039-4556, 20039-4516, and 20039-4362.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on June 1, 2004.
Manufacturer: Blood Systems, Inc, Lafayette LA. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for antibodies to Cytomegalovirus (CMV), were labeled CMV negative and distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0573-5.
CODE
Unit numbers ST-100104, ST-100196, and SP152055.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by letter on September 16, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability determination was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-0577-5.
CODE
Unit numbers VP-190037, VP-191972, VA-147213, VP-191742, VP-191256, VP-191077, VP-190743, VP-192827, VP-190267, VP-184342, VP-189631, VP-189183, VP-189056, VP-188894, VP-188796, VP-184997, VP-184480, and VP-190571.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on September 14, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on an unexplained weight loss, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0580-5.
CODE
Unit number 2296967.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by e-mail on November 4, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a recent blood exposure, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0581-5.
CODE
Unit number 21KK80487.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on December 26, 2003, and by letter on December 30, 2003. 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
OR.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0379-5.
CODE
Unit 2299037.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by telephone on October 8, 2003. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately released from quarantine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ID.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0444-5.
CODE
Units 029KX23811, 029FK56543.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone on September 16, 2004 and September 21, 2004, and by letters dated September 17, 2004, and September 22, 2004. Firm initiated recall is complete.
REASON
Blood products, that did not have the complete amount of additive solution included, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0555-5.
CODE
Unit VP188589.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by facsimile on September 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0567-5.
CODE
Unit number 1199650.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irvin Center, San Francisco, CA, by telephone on March 27, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a reported history of recent illness or surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0568-5.
CODE
Unit number 20037-3997.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 29, 2004.
Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON
Blood product, incorrectly tested for red blood cell antigen C, was labeled C antigen negative and distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0570-5.
CODE
Unit number L58731.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI, by telephone on September 28, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not properly determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Source Plasma. Recall # B-0571-5.
CODE
Unit number VP-188273.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by letter on August 23, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-0572-5.
CODE
Unit number VP-181710.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA, by letter on August 8, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-0578-5.
CODE
Unit number F-28129-011.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Portland, OR, by facsimile on October 17, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-0579-5.
CODE
Unit number F-27044-011.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Portland, OR, by facsimile on October 16, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0582-5;
b) Platelets Pheresis, Leukocytes Reduced.
Recall # B-0583-5;
c) Platelets Pheresis, Leukocytes Reduced
Irradiated. Recall # B-0584-5;
d) Plasma. Recall # B-0585-5;
e) Recovered Plasma. Recall # B-0586-5.
CODE
a) Unit numbers 21V86982, 21V86983, 21V86984,
21V86985, 21V86986, 21V86987, 21V86988,
21V86989, 21V86990, 21V86991, 21V86992,
21V86993, 21V86994, 21V86995, 21V86996,
21V86997, 21V86998, 21V86999, 21V87000,
21V87001, 21V87002, 21V87003, 21V87004,
21V87005, 21V87006, 21V87007, 21V87008,
21V87010, 21V87011, 21V87012, 21V87013,
21V87014, 21V87015, 21V87016, 21V87018,
and 21LQ05968;
b) Unit numbers 21LQ05970, 21KP44067, 21LQ05962,
21LQ05963, 21LQ05967, 21LQ05968, 21KP44051,
21KP44053, 21KP44056, 21KP44057, 21KP44058,
21KP44059, 21KP44060, 21KP44064, and 21KP44066;
and the following units were distributed as
two split products: unit numbers 21KP44070,
21LQ05964, 21LQ05965, 21LQ05966, 21KP44049,
21KP44050, 21KP44054, 21KP44061, 21KP44063,
and 21KP44065;
c) Unit numbers 21LQ05968, 21LQ05969, 21KP44048,
21KP44052, and 21KP44055;
d) Unit numbers 21V86982, 21V86985, 21V86987,
21V86988, 21V86991, 21V86992, 21V86993,
21V86999, 21V87000, 21V87001, 21V87005,
21V87006, 21V87007, and 21V87008;
e) Unit numbers 21V86983, 21V86984, 21V86986,
21V86989, 21V86990, 21V86994, 21V86995,
21V86996, 21V86997, 21V86998, 21V87002,
21V87003, 21V87004, 21V87009, 21V87010,
21V87011, 21V87012, 21V87014, 21V87015,
21V87016, 21V87017, and 21V87018.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR, by telephone on July 11, 2003, and by letter on July 23, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE
112 units.
DISTRIBUTION
OR, WA, CA, TX, KS, and GA.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) Bio Med Devices Patient Breathing Circuit
Catalog Number: 80011 Labeled in part:
":PATIENT BREATHING CIRCUIT =-=-=-= CONTENTS:
1-PATIENT HOSE 22mmIDx42" 1-PRESSURE GAGE
LINE 3/16"IDx54" 1-PATIENT HOSE 22mmIDx24"
3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6"
1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING
ARM & 1-TEMPERATURE ADAPTER 22mmID x 22mm
COLLECTION HEAD 2-CUFF 1û4"ID x 5/4" 1-EXHALATION
VALVE LINE 1/8"IDx52" Recall # Z-0423-05;
b) Bio Med Devices Patient Breathing Circuit
Catalog Number: 80015 Labeled in part:
DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT
BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-
CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER
22mmx22mm 22mmIDx72" w/CLIPS 1-ADULT PRESSURE
TEE w/.140 HOLE 1-LINE 1/8"IDx84" 1-TEE
1/8"x1/8"x1/8" 1-LINE 1/8"IDx24" 1-HOLDING
ARM 1-LINE 1/8"IDx2" 1-CUFF 1û4"IDx2".
Recall # Z-0424-05;
c) Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 8002A PATIENT
BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-
CONTENTS: 1-PATIENT HOSE 22mmIDx42" 1-PRESSURE
GAGE LINE 1-PATIENT HOSE 22mmIDx6" 1-EXHALATION
VALVE w/HOLDING ARM& COLLECTION HEAD 48" w/CUFF
1û4"ID 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION
VALVE LINE 1/8"IDx48" 2-ADAPTERS 22mmx22mm.
Recall # Z-0425-05;
d) Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A-7 Labeled in part: ONE
SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT
BREATHING CIRCUIT =-=-=-=-=-=-=-=-CONTENTS:
1-PATIENT HOSE 22mmIDx60" 1-EXHALATION VALVE
LINE 1/8"IDx90" 1-PATIENT HOSE 22mmIDx18"
1-PATIENT HOSE 22mmIDx6" 1-PRESSURE GAGE LINE
84" w/CUFF 1û4"ID 1-EXHALATION VALVE w/HOLDING
ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE
w/CUFF 3-ADAPTERS 22mmx22mm. Recall # Z-0426-05;
e) Bio Med Devices Patient Breathing Circuit
Catalog Number: 8002A-9 Labeled in part: ONE
SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT
BREATHING CIRCUIT =-= CONTENTS: 1-PATIENT HOSE
22mmIDx60" 1-EXHALATION VALVE LINE 1/8"IDx108"
1-PATIENT HOSE 22mmIDx36" 1-PATIENT HOSE 22mmIDx6"
1-PRESSURE GAGE LINE 1-EXHALATION VALVE w/HOLDING
ARM&COLLECTION HEAD 102" w/CUFF 1û4"ID 1-ADULT
PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm.
Recall # Z-0427-05;
f) Pneumotach, Disposable (B) Catalog Number:
4408 Labeled in part: SINGLE USE CATALOG NO.4408
PNEUMOTACH, DISPOSABLE (B) =-=-=-= CONTENTS: 1-
PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60"2- TUBING
FITTINGS 1- 22x22mm ADAPTER. Recall # Z-0428-05;
g) Bio-Med Patient Breathing Circuit Product Number:
3030-5 Labeled in part: ONE SET - SINGLE USE
CATALOG NO. 3030-5 PATIENT BREATHING CIRCUIT =-=-=-
CONTENTS: 1-PATIENT HOSE 22mmIDx60" 1-PRESSURE GAGE
LINE 1/8"IDx72" 1-PATIENT HOSE 22mmIDx6"
1-EXHALATION VALVE w/COLLECTION HEAD 1-ADULT
PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE
1/8"IDx72 2-ADAPTERS 22mmx22mm. Recall # Z-0429-05;
h) Bio-Med Dental Breathing Circuit Product Number:
DENTL. Recall # Z-0430-05.
CODE
a) Lot Numbers: Last 6 digits 01092304, 01092404,
01092804, 01092904, 01093004, 01100504, 01100604,
01100704 01100804, 01101104, 01101204, 01101404
01101504, 02101804, 01101904, 01102004 01102104,
01102204, 01102504, 05102504 01102604, 01102804,
01102904, 01110104 01110204, 01110504, 09111004,
01111104 05111204, 09111604, 01111704, 01111904
01112204, 09112404, 09113004, 09120204;
b) Lot Numbers: Last 6 digits 09092304, 09092404,
05092704, 02092804 01092904, 05093004, 01100104,
01100404, 01100504, 01101104, 01101204, 01101404
01101804, 01102004, 01102104, 01102504 01102604,
09102704, 09102804, 09110104 09110204, 09110404,
05110804, 09111104 09111504, 01111604, 09111704,
09111804 02111904, 09112204, 09112304, 09112404
05112904, 09113004, 02120104, 09120204;
c) Lot Numbers: last 6 digits 09092204, 01092404,
05093004, 01100604 05100704, 02100804, 05101204,
01101804 09102804, 01110104, 09110404, 05110404
05110904, 05111104, 09111604, 09111804 09111904,
09112204, 09112404, 05120104;
d) Lot Numbers: 05092304, 01092804, 01100104,
05100504 01100604, 05100704, 05101204, 01101304,
05102104, 01102504, 01102604, 09102704 09102804,
09110404, 01110404, 09110504 09110904, 02111004,
09111104, 09111204 09111504, 09112304, 09112904,
09113004 09120104;
e) Lot Numbers: 05092404, 01100404, 05100604,
05100704 05100804, 05101304, 05101404, 05101504
05101904, 05102204, 05102804, 05110404 02110504,
05110804, 01110904, 05111204 05111504, 01111804,
05112204, 09120104;
f) Lot Numbers: 05092204, 05101104, 05101304,
05101404 05102004, 05102604, 05102804, 05110204
05110304, 05110904, 05111804, 05112404 05120104;
g) Lot Number: 09111704;
h) Lot Number: 09110804.
RECALLING FIRM/MANUFACTURER
Bio-Med Devices, Inc., Guilford, CT, by fax on December 7, 2004, and by press release on December 8, 2004. Firm initiated recall is ongoing.
REASON
Adapters may be occluded potentially preventing inhalation.
VOLUME OF PRODUCT IN COMMERCE
970 cases (20/cs).
DISTRIBUTION
Nationwide, and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray. Lioresal drug ampules contained witin Medtronic Lot N0016487 bear the primary manufacturer's label and lot number 007J2583. The drug box is labeled with Lot 017H1925. Medtronic packages a manufacturer's labeled ampule into a protective drug box. A lot number and drug lot expiration date are printed on the outside of the drug box. The filled and labeled drug box is placed inside a larger kit assembly that contains other components necessary to complete a pump refill. Only the large kit assembly ("Lioresal Refill Kit") will display the Medtronic lot number (N0016487). The Model 8561 refill kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump infusion, implanted, programmable under product code LKK. Recall # Z-0391-05.
CODE
N0016487.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN, by telephone on November 19, 2004. Firm initiated recall is ongoing.
REASON
Outer package of Lioresal Intrethecal Refill Kit, Model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml).
VOLUME OF PRODUCT IN COMMERCE
96 kits.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0392-05.
CODE
Software version 2.0.9 for Clintec Compounders.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 8, 2004. Firm initiated recall is ongoing.
REASON
A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being used with the Logix software.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
MD, AZ, IN, OH, MN, PA, and Canada.

_______________________________
PRODUCT
Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0394-05.
CODE
Software version 3.0.4.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing.
REASON
Logix-CM software version 3.0.4 has not completed its official release process.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
AZ, UT, NC, WI, and CA.

_______________________________
PRODUCT
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, Altra Touch 1000, Baxter Tina and Baxter Aurora. Recall # Z-0395-05.
CODE
All System 1000 Delivery System.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Renal Division, Mc Gaw Park, IL, by letters on May 28, 2003. Firm initiated recall is ongoing.
REASON
The air detector may not detect air bubbles consistently at the selected limit.
VOLUME OF PRODUCT IN COMMERCE
28,482 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
HomeChoice PRO Automated Peritoneal Dialysis Systems. Recall # Z-0397-05.
CODE
Units with software version 8.7 used with Physioneal Clear-Flex PD products.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Division, Mc Gaw Park, IL, by notice on December 23, 2004. Firm initiated recall is ongoing.
REASON
A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.
VOLUME OF PRODUCT IN COMMERCE
165 units.
DISTRIBUTION
Denmark and Sweden.

_______________________________
PRODUCT
Ultraview Universal Clinical Workstation System, Model 90385. Recall # Z-0422-05.
CODE
SN: 385-000337 to SN: 385-111440 units with the specified Revision M or earlier base which have not already been updated.
RECALLING FIRM/MANUFACTURER
Spacelabs Medical Inc., Issaquah, WA, by letter on January 7, 2005 and January 14, 2005. Firm initiated recall is ongoing.
REASON
Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.
VOLUME OF PRODUCT IN COMMERCE
12,306 devices.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Harvard 2 Dual Channel Syringe Infusion Pump
P/N 2001-001. Recall # Z-0431-05;
b) Harvard 1 Single Channel Syringe Infusion Pump
P/N 2003-001. Recall # Z-0432-05.
CODE
a) Serial number range: 208002251 - 408203175;
b) Serial number range: 308102012 - 408102213.
RECALLING FIRM/MANUFACTURER
Harvard Clinical Technology, Natick, MA, by letter and telephone on November 3, 2004. Firm initiated recall is ongoing.
REASON
Potential pump motor/encoder assembly failure may cause over infusing medication in patients.
VOLUME OF PRODUCT IN COMMERCE
1,334 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers. List numbers 8C89-01 and 3M74-01. Recall # Z-0435-05.
CODE
All lots manufactured.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on December 14 and 16, 2004. Firm initiated recall is ongoing.
REASON
Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover B-12 results are not impacted.
VOLUME OF PRODUCT IN COMMERCE
6,860 units.
DISTRIBUTION
Internationally.

_______________________________
PRODUCT
Arctic Sun Temperature Management System, Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt). Recall # Z-0436-05.
CODE
Serial numbers 3001 thru 3080.
RECALLING FIRM/MANUFACTURER
Medivance, Inc., Louisville, CO, by telephone and letter on January 5/6, 2005. Firm initiated recall is ongoing.
REASON
Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.
VOLUME OF PRODUCT IN COMMERCE
67 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents. Recall # Z-0437-05.
CODE
Lot no. X1004212.
RECALLING FIRM/MANUFACTURER
Cordis Corp., Miami Lakes, FL, by letter on January 12, 2005. Firm initiated recall is ongoing.
REASON
Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specifications were met.
VOLUME OF PRODUCT IN COMMERCE
300 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) The Hospira Plum A + I.V. Infusion pump is a
cassette-based, multi-function fluid delivery
infusion system, consisting of pumping module and
assortment of IV sets. Recall # Z-0438-05;
b) The Hospira Plum A + 3 I.V. Infusion pump is a
cassette-based, multi-function fluid delivery
infusion system, consisting of pumping module and
assortment of IV sets. Recall # Z-0439-05.
CODE
a) All lots (serial numbers) are currently under
recall. List No 11971-04 and List No. 12391-04.
b) All lots (serial numbers) are currently under
recall. List No 12618-04 and List No. 12348-08.
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Morgan Hill, CA, by letter on September 8, 2004. Firm initiated recall is ongoing.
REASON
The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.
VOLUME OF PRODUCT IN COMMERCE
31,914 units.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR February 9, 2005

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