September 10, 2003
03-37
_______________________________
PRODUCT
Asian Boy (E.B.Q.) brand Sweet Lotus (Confiture de noix de lotus), Net Wt. - Poids Net: 8 oz (227 g). Product of Vietnam. Product is packaged in a rigid plastic round container (tub). Recall # F-513-3.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
B. C. N. Trading, Inc., Brooklyn, NY, by press release and letter dated May 20, 2003. New York State initiated recall is complete.
REASON
The product contained undeclared sulfites based on NYSDAM sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
5,616 - 227 g plastic tubs.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Product is frozen Breaded Stuffed Shrimp Sea Est Brand which is sold for institutional/food service use. It is packaged in individual 3.5 lb cartons which have an insert label placed in with the individual 28/ 2 oz. breaded stuffed shrimp portions. In addition 6 cartons are packed into a Master Case labeled BREADED STUFFED SHRIMP 5004110 NET WT 21 LBS PRODUCT OF U.S.A. Recall # F-514-3.
CODE
All lot numbers of product item # 5004110 (on master case) are under recall. The two lot numbers involved are 549802 and 555077.
RECALLING FIRM/MANUFACTURER
Beaver Street Fisheries, Inc., Jacksonville, FL, by letter on June 20, 2003. FDA initiated recall is complete.
REASON
The label for frozen breaded stuffed shrimp did not list nonfat dry milk, a sub-ingredient of the batter.
VOLUME OF PRODUCT IN COMMERCE
123 cases.
DISTRIBUTION
TX, IL, and LA.
_______________________________
PRODUCT
a) Viga Tablets (Naturalviagra), 200 mg, 20 and 30 count
bottles and 4 tablet sample packets, Each tablet
contains: Ginseng-40mg, Oat straw-10mg, Mauria puama-
10mg, DHEA-10mg, Saw palmentto-40mg, Tribulus
terrestris-40mg, Yohimbe extract-40mg, and
Androstenedione-10mg. Recall # D-322-3;
b) Viga for Women tablets, BEST LIFE, 20 tablet bottles,
Ingredients: Mauria Puama, Ginseng, Maca, Wild Yam,
DAmiana, L-Argining, Dong Qual., Guarana, Horney Goat
Weed, and Macuna Prurions Extract. Recall # D-323-3.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: RMA Laboratories, Inc., Paramount, CA, by press release on June 24, 2003, and by letters on May 12, 2003 through July 8, 2003.
Manufacturing Firm: Health Nutrition Inc., Torrance, CA. and/or Best Life International, Inc. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contains undeclared prescription drug Sildenafil.
VOLUME OF PRODUCT IN COMMERCE
Approx. 6 million tablets.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
a) Viga Tablets (Naturalviagra), 200 mg, 20 and 30 count
bottles and sample packets of 4 tablets, Ingredients:
Ginseng, Oat straw, Melria puama, DHEA, Saw palmentto,
Tribulus, Yohimbe, and Androstenedione, Inc.
Recall # D-324-3;
b) Viga for Women tablets, 20 count bottles, (Natural
Stimulant), Ingredients: Mauria Puama, Ginseng, Maca,
Wild Yam, DAmiana, L-Argining, Dong Qual., Guarana,
Horney Goat Weed, and Macuna Prurions Extract.
Recall # D-325-3.
CODE
a) Catalog numbers 10725 All Lots.
b) Catalog numbers 10728 All Lots.
RECALLING FIRM/MANUFACTURER
Best Life International Inc., Mayaguez, PR, by letter on May 23, 2003. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contains the undeclared prescription drug ingredient Sildenafil.
VOLUME OF PRODUCT IN COMMERCE
29,992 bottles.
DISTRIBUTION
Puerto Rico.
_______________________________
PRODUCT
VINAROL with VASX Tablets, 500mg, blister packages of 2 or 7 tablets, Each tablet contains a proprietary blend of Cassia Tree, Dodder Seed, Epimedium, Wolfbery, Saling, Cistanche, Mangolia Vine Fruit, Red Raspberry, Narrow Leaved Polygala, Rehmannia Root, Eucommia Bark, Hindo Lotus Seed, Bidemate Bark, Milk Vetch Seed, Cherokee Rose, Arborviate Seed, American Ginseng, Ginko Bilboa, Bionate International, Inc. Phoenix, AZ. Recall # D-326-3.
CODE
Lot 030060 Exp 11/2006 thru 3/2007;
Lot 020245 Exp 11/2006 thru 3/2007.
RECALLING FIRM/MANUFACTURER
Bionate International, Inc., Scottsdale, AZ, by press release on April 7, 2003, and by letters on May 27, 2003. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product contains undeclared prescription drug sildenafil.
VOLUME OF PRODUCT IN COMMERCE
1-6 million tablets.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 112 mcg, 100 count bottles, Rx only, Repackaged by: American Health Packaging, Columbus, OH, NDC 52604-5112-1. Recall # D-321-03.
CODE
Lot #024737, Exp. May 31,2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on July 8, 2003.
Manufacturing Firm: Jones Pharma Inc, (A wholly owned subsidiary of King Pharmaceuticals, Inc.), St. Louis, MO. Firm initiated recall is ongoing.
REASON
Tablet mix-up: bottles labeled as Levoxyl 112mcg tablets were found to contain Soloxine 0.2mg tablets (Vet/Animal brand-Levothyroxine).
VOLUME OF PRODUCT IN COMMERCE
4,218 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Sporanox Injection Kit (Itraconazole), 10mg/mL, 25mL ampule, One Unit Dose Ampule per kit, Rx only, NDC 50458-298-01 (kit). Recall # D-305-3.
CODE
02F03AIW (02/04); 02F04AIW (02/04); 02G01AZ7 (04/04); 02H02AZ7 (04/04); 02J01AZ7 (02/04) 02J02AZ7 (02/04); 02J03AZ7 (05/04); 02J03BZ7 (05/04) 02L02AZ7 (07/04); 02L03AZ7 (07/04); 02L04AZ7 (08/04).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho Biotech Products LP, Raritan, NJ, by letters on June 27, 2003.
Manufacturing Firm: Abbott Laboratories, North Chicago, IL. Firm initiated recall is ongoing.
REASON
Discoloration; incorrect connector piece included in the Abbott Microbore Extension Set/Kit may become discolored.
VOLUME OF PRODUCT IN COMMERCE
60,000 kits.
DISTRIBUTION
Nationwide, Germany and Israel.
_______________________________
PRODUCT
Trionate Suspension (Each 5 mL (one teaspoon full) contains: Carbetapentane Tannate, 30mg and Chlorphentramine Tannate, 4mg), RX only, Net Contents: 16 fl. oz. (one pint) 473 mL, NDC 51991-071-16. Recall # D-309-3.
CODE
L021261, L021J011 and L02L111.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Breckenridge Pharmaceutical Inc., Boca Raton, FL, by letters on March 18, 2003.
Manufacturing Firm: Unigen Pharmaceuticals, Inc. Westminster, MD. Firm initiated recall is complete.
REASON
Contamination; product complaints of black particulates and/or mold, appearance changes and "off" taste.
VOLUME OF PRODUCT IN COMMERCE
4,242 bottles.
DISTRIBUTION
Nationwide and Puerto Rico.
_______________________________
PRODUCT
Platelets. Recall # B-1585-3.
CODE
Unit 22FJ83123.
RECALLING FIRM/MANUFACTURER
American Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on April 9, 2003, and by letter dated April 14, 2003. Firm initiated recall is complete.
REASON
Platelets, prepared from a donation that had discrepant start and stop collection times documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1598-3.
CODE
Unit 9575567, 9575568.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on January 23, 2003. Firm initiated recall is complete.
REASON
Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1606-3.
CODE
Unit BFDTKP.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Fort Worth, TX, by letter dated February 27, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1609-3.
CODE
Unit N36575.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on October 23, 2002. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low percent red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1610-3.
CODE
Unit N30407.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on October 10, 2002. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low percent red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.
_______________________________
PRODUCT
Source Plasma, Recall # B-1615-3.
CODE
Unit G12679030.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Youngstown, OH, by fax on February 13, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.
_______________________________
PRODUCT
a) Red Blood Cells. Recall B-1617-3;
b) Platelets. Recall # B-1618-3;
c) Recovered Plasma. Recall # B-1619-3.
CODE
a), b), and c) Unit 7412196.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on June 15, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX and Switzerland.
_______________________________
PRODUCT
Source Plasma. Recall # B-1625-3.
CODE
Unit BFFFDK.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Fort Worth, TX, by letter dated November 17, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1658-3.
CODE
Unit number LSG016067.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Las Vegas, NV, by letter on October 30, 2001. 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-1659-3.
CODE
Unit number LG0146446.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Las Vegas, NV, by letter on November 19, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1662-3;
b) Platelets. Recall # B-1663-3.
CODE
a) and b) Unit 2947521.
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter on July 3, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-1664-3.
CODE
Unit number 8757108.
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letter on April 8, 2003. Firm initiated recall is complete.
REASON
Blood product that was possibly out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
_______________________________
PRODUCT
Becton Dickinson's ProbeTec( ET Instrument. Recall # Z-1094-03.
CODE
Instrument serial numbers 1001-2056.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co., Sparks, MD, by letter on July 21, 2003. Firm initiated recall is ongoing.
REASON
Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.
VOLUME OF PRODUCT IN COMMERCE
1,015 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Sarns MP4 Cardioplegia Sets; catalog number 15501. Recall # Z-0664-3.
CODE
Lot 322125.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by telephone beginning on February 25, 2003, and letter dated February 27, 2003. Firm initiated recall is complete.
REASON
There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
VOLUME OF PRODUCT IN COMMERCE
208.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box. Recall # Z-0977-03.
CODE
Lot numbers 24C06B, 24C06D, 24C06E, 24D04S.
RECALLING FIRM/MANUFACTURER
Watson Diagnostics, Inc., Corona, CA., by letter on August 7, 2003. Firm initiated recall is ongoing.
REASON
Lights split, spilling contents when bent to activate.
VOLUME OF PRODUCT IN COMMERCE
662.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Femoral Resection Guide, Scorpio L.R.S. Instrumentation. Recall # Z-1143-03.
CODE
Catalog No: 8050-5103; 8050-5105; 8050-5107; 8050-5109; 8050-5111; 8050-5113.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Mahwah, NJ, by letters on July 17, 2003. Firm initiated recall is ongoing.
REASON
Scorpio Femoral Resection Guides have the potential to remove more bone than necessary.
VOLUME OF PRODUCT IN COMMERCE
102.
DISTRIBUTION
Canada, and Ireland.
_______________________________
PRODUCT
Integris Monitor Arm; model P997-04. Recall # Z-1145-03.
CODE
All units manufactured prior to June 20, 2003.
RECALLING FIRM/MANUFACTURER
Hill-Rom Co, Inc., Batesville, IN, by letter dated August 8, 2003. Firm initiated recall is ongoing.
REASON
The monitor may separate from the monitor arm, allowing the monitor to fall from the arm.
VOLUME OF PRODUCT IN COMMERCE
2,778.
DISTRIBUTION
Nationwide, and Internationally.
_______________________________
PRODUCT
Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5). Recall # Z-1146-03.
CODE
Catalog # 209-04-71, Lot # 10315011, Catalog # 209-04-72, Lot # 10315012; Catalog # 209-04-73, Lot # 10315013; Catalog # 209-04-74, Lot # 10315014 and Catalog # 209-04-75, Lot # 10315015.
RECALLING FIRM/MANUFACTURER
Exactech, Inc., Gainesville, FL., by letters dated July 30, 2003. Firm initiated recall is ongoing.
REASON
The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray.
VOLUME OF PRODUCT IN COMMERCE
137.
DISTRIBUTION
OH, ME, HI, and NY.
_______________________________
PRODUCT
a) Baxter Solution Set, 10 drops/mL, 101", Male LuerLock
Adapter, catalog 1C8109; Baxter Healthcare Corporation,
Deerfield, IL, USA. Recall # Z-1150-03;
b) Interlink System Solution Set with Microbore Tubing,
60 Drops/mL, 123", 2 injection sites, Male Luer Lock
Adapter, catalog 2C6426; Baxter Healthcare Corporation,
Deerfield, IL, USA. Recall # Z-1151-03;
c) Interlink System Continu-Flo Solution Set with Microbore
Tubing, 60 drops/mL, 128", 3 injection sites, Male Luer
Lock Adapter, catalog 2C6521; Baxter Healthcare
Corporation, Deerfield, IL, USA. Recall # Z-1152-03;
d) Continu-Flo Solution Set, 10 drops/mL, 104", 0.22 Micron
Downstream High Pressure Extended Life Filter, 3
Injection Sites, Male Luer Lock Adapter, catalog 2C6593;
Baxter Healthcare Corporation, Deerfield, IL, USA.
Recall # Z-1153-03;
e) Interlink System Vented Nitroglycerin Set, 104", PVC
Tubing Segment, Injection Site, Male Luer Lock Adapter,
catalog 2C7551; Baxter Healthcare Corporation,
Deerfield, IL, USA. Recall # Z-1154-03;
f) Baxter Vented Nitroglycerin Set, 105", PVC Tubing
Segment, Injeciton Site, Male Luer Lock Adapter, catalog
2C7552; Baxter Healthcare Corporation, Deerfield, IL,
USA. Recall # Z-1155-03;
g) Clearlink System Continu-Flo Solution Set, 10 drops/mL,
113", 2 Luer Activated Valves, Male Luer Lock Adapter,
catalog 2C8519; Baxter Healthcare Corporation,
Deerfield, IL, USA. Recall # Z-1156-03;
h) Clearlink System Nitroglycerin Set with DUO-VENT Spike,
60 drops/mL, 105", PVC Tubing Segment, Luer Activated
Valve, Male Luer Lock Adapter, catalog 2C8851; Baxter
Healthcare Corporation, Deerfield, IL, USA.
Recall # Z-1157-03;
i) Clearlink System Vented Paclitaxel Set, 10 drops/mL,
111", Polyethylene Lined Tubing, Non-DEHP Pump Segment,
0.22 Micron Extended Life Filter, Luer Activated Valve,
Male Luer Lock Adapter, catalog 2C8857; Baxter
Healthcare Corporation, Deerfield, IL.
Recall # Z-1158-03;
j) Continu-Flo Solution Set, 60 drops/mL, 106", 3 Luer
Activated Valves, Male Luer Lock Adapter, catalog
2C9906; Baxter Healthcare Corporation, Deerfield, IL.
Recall # Z-1159-03;
k) Baxter Y-Type Blood/Solution Set, 10 drops/mL, 112",
Standard Blood Filter, 170 to 260 Micron Filter,
Injection Site, Male Luer Lock Adapter, catalog 2C6750;
Baxter Healthcare Corporation, Deerfield, IL, USA.
Recall # Z-1160-03;
l) Clearlink System Y-Type Blood/Solution Set, 10 drops/mL,
112", Standard Blood Filter, 170 to 260 Micron Filter,
Luer Activated Valve, Male Luer Lock Adapter, catalog
2C8750; Baxter Healthcare Corporation, Deerfield, IL.
Recall # Z-1161-03;
m) Fenwal Y-Type Blood/Solution Set with Large Standard
Blood Filter and Pressure Pump, 15 drops/mL, 99", 170 to
260 Micro Filter, Large Standard Blood Filter, 2
Injection Sites, Male Luer Lock Adapter, catalog 4C6723;
Baxter Healthcare Corporation, Deerfield, IL.
Recall # Z-1162-03;
n) Fenwal Y-Type Blood/Solution Set with Large Standard
Blood Filter, 15 drops/mL, 89", 170 to 260 Micron
Filter, Large Bore Tubing, Male Luer Lock Adapter,
catalog 4C7776A; Baxter Healthcare Corp., Deerfield, IL.
Recall # Z-1163-03;
o) Colleague Pump Syringe Adapter Set, 92", Injection Site,
Non-DEHP Tubing, Luer Lock Adapters, catalog 2C0169;
Baxter Healthcare Corp, Deerfield, IL. Recall # 1164-03;
p) Baxter Y-Type Blood/Solution Set with Pressure Pump, 10
drops/mL, 99", 170 to 260 Micron Filter,Large Standard
Blood Filter, 2 Injection Sites, Male Luer Lock Adapter,
catalog 2C6723; Baxter Healthcare Corp., Deerfield, IL.
Recall # Z-1165-03;
q) Baxter Solution Set, 10 drops/mL, 76", Luer Activated
Valve, Male Luer Lock Adapter, catalog 2C9901; Baxter
Healthcare Corp., Deerfield, IL. Recall # Z-1166-03;
r) Baxter Solution Set, 60 drops/mL, 76", Luer Activated
Valve, Male Luer Lock Adapter, catalog 2C9902; Baxter
Healthcare Corp., Deerfield, IL. Recall # Z-1167-03;
s) Vented Solution Set, 10 drops/mL, 92", Luer Activated
Valve, Male Luer Lock Adapter, catalog 2C9903; Baxter
Healthcare Corp., Deerfield, IL. Recall # Z-1168-03;
t) Continu-Flo Solution Set, 10 drops/mL, 110", 3 Luer
Activated Valves, Male Luer Lock Adapter, catalog
2C9905; Baxter Healthcare Corporation, Deerfield, IL.
Recall # Z-1169-03;
u) Continu-Flo Solution Set, 10 drops/mL, 113", 2 Luer
Activated Valves, Male Luer Lock Adapter, catalog
2C9907; Baxter Healthcare Corporation, Deerfield, IL.
Recall # Z-1070-03;
v) Baxter Y-Type Blood/Solution Set, 10 drops/mL, 115", 80
Micron Filter, Injection Site, Male Luer Lock Adapter,
catalog 2C7617; Baxter Healthcare Corporation,
Deerfield, IL. Recall # Z-1171-03;
w) Baxter Y-Type Blood/Solution Set with Pressure Pump, 10
drops/mL, 99", Large Standard Blood Filter, 170 to 260
Micron Filter, 2 Injection Sites, Male Luer Lock
Adapter, catalog 2C7623; Baxter Healthcare Corporation,
Deerfield, IL. Recall # Z-1172-03.
x) Fenwal Blood Component Recipient Set with Standard Blood
Filter, 10 drops/mL, 55", 170 to 260 Micron Filter,
catalog 4C2100; Baxter Healthcare Corporation,
Deerfield, IL. Recall # Z- 1173-03.
y) Fenwal Y-Type Blood Component Recipient Set with
Standard Blood Filter, 10 drops/mL, 65'', 170 to 260
Micron Filter, catalog 4C2196; Baxter Healthcare
Corporation, Deerfield, IL. Recall # Z-1174-03;
z) Fenwal Straight Type Blood Set with Large Standard Blood
filter, 15 drops/mL, 80'', 170 to 260 Micron Filter,
Injection Site, Male Luer Lock Adapter, catalog 4C6766;
Baxter Healthcare Corporation, Deerfield, IL.
Recall # Z-1175-03;
aa) Fenwal Y-Type Blood/Solution Set with Large Standard
Blood Filter, 15 drops/mL, 107", 2 Injection Sites, Male
Luer Lock Adapter, catalog 4C7774; Baxter Healthcare
Corporation, Deerfield, IL. Recall # Z-1176-03;
bb) Fenwal Y-Type Blood/Solution Set with Large Standard
Blood Filter, 10 drops/mL, 82", 170 to 260 Micron
Filter, Large Bore Tubing, Male Luer Lock Adapter,
catalog 4C7776; Baxter Healthcare Corporation,
Deerfield, IL. Recall # Z-1177-03.
CODE
a) Lot numbers UR139824 through UR168476.
Please note: Baxter lot numbers are represented by an
internal reference code "UR" followed by a six digit
sequential number, or by the letter "U" followed by a
six digit sequential number with and "R" suffix. Any lot
number appearing within the identified six digit
sequential number range is subject to the recall;
b) Lot number UR146407;
c) Lot numbers UR117432 through UR167015;
d) Lot numbers UR161117 through UR167718;
e) Lot numbers UR133769 through UR165696;
f) Lot numbers UR142943 through UR167627;
g) Lot numbers UR129585 through UR168716;
h) Lot numbers UR141788 through UR167684;
i) Lot numbers UR134353 through UR157545;
j) Lot numbers U573428R through UR168989;
k) Lot numbers UR151456 through UR158261;
l) Lot numbers UR128876 through UR168104;
m) Lot numbers UR150458 through UR166892;
n) Lot numbers UR160143 through UR166538;
o) Lot numbers UR152843 through UR164376;
p) Lot numbers UR144147 through UR158808;
q) Lot numbers U563262R through UR102517;
r) Lot numbers U565523R through U573899R;
s) Lot numbers U568576R through UR135046;
t) Lot numbers U556902R through UR126946;
u) Lot numbers U569160R through UR131276;
v) Lot numbers UR147777 through UR157008;
w) Lot numbers UR124917 through UR158857;
x) Lot numbers UR110346 through UR123513;
y) Lot numbers UR117606 through UR122614;
z) Lot numbers UR140772 through UR166058;
aa)Lot numbers UR144543 through UR156901;
bb)Lot numbers UR153460 through UR153494.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare, Corp., Round Lake, IL, by letter dated July 16, 2003. Firm initiated recall is ongoing.
REASON
There are possible pinholes or perforations in the set tubing, caused by damage that occurred during the packaging process.
VOLUME OF PRODUCT IN COMMERCE
4,534,365 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Spiral Z Expandable Metal Biliary Stent.
Recall # Z-1179-03;
b) Za-Stent Expandable Metal Biliary Stent.
Recall # Z-1180-03;
c) Zilver Expandable Metal Biliary Stent.
Recall # Z-1181-03.
CODE
a) Reorder #SZBS-10-7.5-C, Amended 8/8/2003 to include
SZBS-10-5.7-C;
b) Reorder #ZABS-10-8-C, Amended 8/8/2003 to include:
ZABS-10-4-C, ZABS-10-6-C;
c) Reorder #ZILBS-6-6, , ZILBS-10-8, ZILBS10-6, Amended
8/8/2003 to include: ZILBS-10-4, ZILBS-8-4, ZILBS-8-6,
ZILBS-8-8, ZILBS6-4, ZILBS-6-8.
RECALLING FIRM/MANUFACTURER
Wilson-Cook Medical Inc., Winston-Salem, NC, by letter on August 8, 2003. Firm initiated recall is ongoing.
REASON
The inner catheter of the introducer system may break after stent deployment.
VOLUME OF PRODUCT IN COMMERCE
12,144 units.
DISTRIBUTION
Nationwide, and Internationally.
_______________________________
PRODUCT
a) Optima Poly Screw Driver, Part OP20002 Revision C.
Recall # Z-1182-03;
b) Optima Large Poly Screw Driver, Part OP20012 Revision B.
Recall # Z-1183-03.
CODE
a) Lot No. 03030301 and 05120308;
b) Lot No. 04240301 and 04140302.
RECALLING FIRM/MANUFACTURER
U & I America, Murray, UT, by letter on August 18, 2003. Firm initiated recall is ongoing.
REASON
Reports of pieces chipping off the tip of screwdriver during use.
VOLUME OF PRODUCT IN COMMERCE
310 units.
DISTRIBUTION
MN.
_______________________________
PRODUCT
a) 1680 Invisatrace series ECG Electrodes, radiotranslucent
clear tape ECG electrode with wet gel. This is a single
use, disposable device. Electrodes are packaged and sold
as: 1) Cat No 1680-001 (1 unit per pouch/30 per box);
2) Cat No 1680-003 (3 units per pouch/30 per box);
3) Cat No 1680-005 (5 units per pouch/50 per box); and
4) Cat No 1680-030 (30 units per pouch/no box).
The electrodes are packaged 600 units/case.
Recall # 1184-03;
b) 1690 Ultratrace Series ECG Electrodes, clear tape ECG
electrode with wet gel. This is a single use, disposable
device. Electrodes are packaged and sold as:
Cat No 1690-001 (1 unit per pouch/30 per box);
Cat No 1690-003 (3 units per pouch/30 per box);
Cat No 1690-005 (5 units per pouch/50 per box);
Cat No 1690-010 (50 units per pouch/no box/ 1000 per case);
Cat No 1690-030 (30 units per pouch/no box). The above are sold in boxes of 600 with the exception of 1690-010 (sold 1000 per case) as noted above. Recall # Z-1185-03.
CODE
a) 1) 0305301, 0306091, 0306092;
2) 0306241;
3) 0306042;
4) 0306021, 0306051.
b) 1) 0306092, 0306201, 0306202;
2) 0305231, 0305232, 0306201;
3) 0305162, 0305221, 0305301, 0306031, 0306042, 0306051,
0306191, 0306252, 0306301;
4) 0305231, 0306171;
5) 0305281, 0306031, 0306051, 0306101, 0306131, 0306161,
0306231, 0306232, 0306261.
RECALLING FIRM/MANUFACTURER
Conmed Corporation, Utica, NY, by letters dated July 30, 2003. Firm initiated recall is ongoing.
REASON
Separation of the sensing element from the body of the electrode.
VOLUME OF PRODUCT IN COMMERCE
1,003,072.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Abbott Aeroset System list number 9D05-01. Recall # Z-1142-03.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter dated December 29, 2000. Firm initiated recall is complete.
REASON
ICT assays run using a manual dilution will not be calculated correctly by the software.
VOLUME OF PRODUCT IN COMMERCE
143.
DISTRIBUTION
Nationwide, and Internationally.
_______________________________
PRODUCT
Bardex(r) Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device. The catheter is an open whistle tip with two eyes on the same side. It is made of red latex for added catheter stiffness and radiopacity, with a Lubricath hydrophilic coating. This product has 3 lumens; a lumen for drainage, a lumen for inflation of the bladder balloon, and a lumen for inflation of the prostatic balloon. Catalog Number 6016L22. Recall # Z-1144-03.
CODE
All units packaged from January 1999 and shipped prior to September 2002.
RECALLING FIRM/MANUFACTURER
C. R. Bard, Inc., Urological Division, Covington, GA, by letter on August 29, 2002. Firm initiated recall is complete.
REASON
On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports.
VOLUME OF PRODUCT IN COMMERCE
1,461 units.
DISTRIBUTION
Nationwide, Canada, Belgium and Germany.
_______________________________
PRODUCT
Anti-Cardiolipin IgA ELISA test kit. Product is manufactured for Sigma Diagnostics, Inc., Saint Louis, MO. Recall # Z-1147-03.
CODE
Sigma Product number 552-B; Lot Number 060K6464 Expiration Date: 12-05-2001.
RECALLING FIRM/MANUFACTURER
Zeus Scientific, Inc., Branchburg, NJ, by letter on June 22, 2001. Firm initiated recall is complete.
REASON
Bacterial contamination of the high positive control.
VOLUME OF PRODUCT IN COMMERCE
130.
DISTRIBUTION
MO.
_______________________________
PRODUCT
Access Immunoassay System Technical Update 03.1, Part number 387851. Recall # Z-1148-03.
CODE
Software version 3.29.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA., by telephone between June 18, 2003 and July 3, 2003. Firm initiated recall is ongoing.
REASON
Defective software media distributed with upgrade software may cause installation failure and systems lock.
VOLUME OF PRODUCT IN COMMERCE
1,615.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
ABX Diagnostices Pentra 60C+ Hematology Analyzer. Recall # Z-1149-03.
CODE
Software versions of up to 1.7.
RECALLING FIRM/MANUFACTURER
ABX Diagnostics, Inc., Irvine, CA, by letter on June 5, 2003. Firm initiated recall is ongoing.
REASON
Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
VOLUME OF PRODUCT IN COMMERCE
159.
DISTRIBUTION
Nationwide.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 10, 2003
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