FDA

Enforcement Report

December 1, 1999                                    99-48

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS I
________
PRODUCT
Invigorate(tm) Liquid Drink in 32 fluid ounce plastic bottles.  
Product label declares as an ingredient �(3H) �3H) Furanone 
Di-hydro�, which is also known as gammabutyrolactone (GBL).  The 
supplement which stimulates the body抯 own production of human 
growth hormone and as a sleep aid which 搘ill induce deep 
invigorating sleep that will last 3-4 hours.  Recall #D-057-0.
CODE
All lot codes remaining on the market.
MANUFACTURER
Invigorate International, New York, New York.
RECALLED BY
Cabot Industries, LLC, West Babylon, New York, by letter on June 
1, 1999, followed by telephone.  FDA Requested and subsequently 
ordered by the Eastern District Court of New York.  
DISTRIBUTION
New York, New Jersey, Massachusetts, Pennsylvania, Maryland, 
Virginia, Ohio, South Carolina, Florida, Alabama, Mississippi, 
Michigan, Illinois, Kansas, Colorado.




QUANTITY
Undetermined.
REASON
Product is an unapproved new drug.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
_______
PRODUCT
Various Rx products:
1.  Dobutamine Injection, USP, 250 mg, 20 mL Single Dose Vial 
2.  Etopside Injection, USP, 100 mg, 5 mL Multiple Dose Vial 
3.  Etopside Injection, USP, 150 mg, 7.5 mL Multiple Dose Vial 
4.  Etopside Injection, USP, 500 mg, 25 mL Multiple Dose Vial 
5.  Etopside Injection, USP, 1 g, 50 mL Multiple Dose Vial
6.  Fentanyl Citrate Injection, USP, 1000 mcg, 20 mL Single Dose 
Vial
7.  Fentanyl Citrate Injection, USP, 2500 mcg, 50 mL Single Dose 
Vial
8.  Heparin Sodium Injection, USP, 1000 USP units/mL, 5 mL Ampul
9.  Lorazepam Injection, USP, 1 mg/0.5mL syringe
10.  Lorazepam Injection, USP, 4 mg/mL , 1 mL syringe
11.  Lorazepam Injection, USP, 2 mg/mL , 1 mL and 10 mL  Multiple 
Dose Vials
12.  Lorazepam Injection, USP, 4 mg/mL , 1 mL and 10 mL  Multiple 
Dose Vials
13.  Morphine Sulfate Injection, USP, 15 mg/mL, 20 mL Multiple 
Dose Vial
14.  Morphine Sulfate Injection, USP, 100mg/4mL, 4 mL Single Use 
Vial
15.  Morphine Sulfate Injection, USP, 250/10mL, 10 mL Single Use 
Vial
16.  Morphine Sulfate Injection, USP, 500 mg/20mL, 20 mL Single 
Use Vial
17.  Morphine Sulfate Injection, USP, 1g/40mL, 40 mL Single Use 
Vial
18.  Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 500 
mg/10mL, 10 mL Single Use Vial
19.  Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 
1g/20mL, 20 mL Single Use Vial
20.  Morphine Sulfate Injection, USP, NO BACTERIOSTAT ADDED, 
2g/40mL, 40 mL Single Use Vial
21.  Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 
100mg/4mL, 4 mL Single Use Vial
22.  Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 
250mg/10mL, 10 mL Single Use Vial
23.  Morphine Sulfate Injection, USP, PRESERVATIVE FREE, 
500mg/20mL, 10 and 20 mL Single Use Vial
24.  Morphine Sulfate Injection, USP, PRESERVATIVE FREE,  
1g/40mL, 40 mL Single Use Vial
25.  Neostigmine Methylsulfate Injection, USP, 0.5mg/mL, 10 mL 
Multiple Dose Vial
26.  Neostigmine Methylsulfate Injection, USP,  1mg/mL, 10 mL 
Multiple Dose Vial
27.  Tobramycin Sulfate Injection, USP, 20 mg, 2 mL vial
28.  Tobramycin Sulfate Injection, USP, 80 mg, 2 mL vial
29.  Tobramycin Sulfate Injection, USP, 40 mg/mL, 30 mL Multiple 
Dose Vial.  Recall #D-064/092-0.
CODE
All lot codes.
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
Manufacturer, by letter on July 1 and 7, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
Undetermined.
REASON
Insufficient equipment cleaning (equipment residues detected talc 
and aliphatic hydrocarbon).
________
PRODUCT
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, in 30 ml 
vial, an adrenocortical steriodal anti-inflammatory drug, 
intended for administration by intravenous, intramuscular, intra-
articular, intra-lesional, and soft tissue routes, under the 
following labels:  NDC 0402,-0807-30 (Steris Laboratories, Inc.); 
NDC 0364-6681-56 (Schein Pharmaceutical, Inc.); NDC 0182-3007-66 
(Zenith Goldline)
NDC 12671-807-30 (Ace Surgical Supply).
Recall #D-096-0.
CODE
Lot Numbers: 98B790 EXP 9/99, 98E010 EXP 9/99, and 98E020 EXP 
10/99.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY
Manufacturer, by letter on August 20, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
81,958 units were distributed.
REASON
Insufficient test methods for product release to assure identity, 
strength, purity, and quality.
________
PRODUCT
Rocaltrol Capsules, (Calcitriol), 0.25 mcg, Rx, in 100 capsule 
bottles.  NDC #004-0143-01.  Recall #D-102-0.
CODE
Lot #0419 EXP 10/31/00.
MANUFACTURER
Roche Laboratories, Inc., Nutley, New Jersey.
RECALLED BY
Manufacturer, by telephone on April 6, 1999, and by letter sent 
on April 8, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
173 bottles were distributed.
REASON
Potential microbial contamination (Bacillus 
cereus/Methylobacterium sp).
________
PRODUCT
Liquid Medical Oxygen USP, contained in cyrogenic units, 
Rx used for respiratory therapy.
Recall #D-103-0.
CODE
All lots transfilled between 1/11/99 and 4/19/99 and lot 
#05119961 transfilled on 5/11-12/99.
MANUFACTURER
Home Care Supply Holdings, Bethpage, New York.
RECALLED BY
Manufacturer, by letter on July 7, 1999.  FDA-initiated recall 
complete.
DISTRIBUTION
New York.
QUANTITY
35 vessels were distributed; firm estimated that none remained in 
commerce.
REASON
Current good manufacturing practice deviations including but not 
limited to failure to assay for identity and strength.
________
PRODUCT
Gentamicin Sulfate, USP, bulk and in 50 kg fiber drums, Rx, for 
manufacturing use only.  Recall #D-104-0.
CODE
All lots with prefix SC-GM 96, SC-GM 97, SC-GM 98 and SCGM99.
MANUFACTURER
Long March Pharmaceutical Plant, Leshan, Sichuan, Peoples 
Republic of China.
RECALLED BY
Helm New York, Inc., Piscataway, New Jersey, by telephone between 
Septenber 8 and 16, 1999, followed by letter.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Missouri, New York, Illinois, California, New Jersey, Iowa, Iowa, 
Arizona, Ohio.
QUANTITY
26,953 kg. were distributed; firm estimated that 1,500 kg. 
remained on market at time of recall initiation.
REASON
Current good manufacturing practice deviations (at manufacturing 
site in China).
________
PRODUCT
Derma-Clear(tm), Skin Bleaching Treatment and Jeval A-
Peel, Skin Bleaching Treatment, over-the-counter topical 
cream in 2 and 4 Oz. Plastic jars, (same ingredients, 2 
trade names for distribution).  Recall #D-108-0.
CODE
Lot Number        Batch Number
90-0-5            3728
0-0-5             3728
1234567890-7      4314
234567890-7       5109
34567890-7        5245
4567890-7         5461
567890-7          6197
67890-7           6242
7890-7            7237.
MANUFACTURER
Cosmetic Specialty Labs, Inc. (CSL), Lawton, Oklahoma.
RECALLED BY
Manufacturer, by letter dated April 26, 1999 Firm-
initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
5,279 units were distributed.
REASON
Product is a new drug without new drug approval (contains 
more than 2% hydroquinone).
________
PRODUCT
Country Health Formula #63 MSM Eye and Ear Drops, OTC, in 1 ounce 
bottles, distributed by BioMechanics, Aberdeen, Idaho.  Recall 
#D-109-0.
CODE
Lot Numbers:  433, 7538, 9463 and 9749.
MANUFACTURER
Cosmetic Specialty Labs, Inc., Lawton, Oklahoma.
RECALLED BY
Manufacturer, by letter dated April 5, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Idaho.
QUANTITY
541 containers were distributed.
REASON
Current good manufacturing practice deviations.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
Anzemet Tablets (Dolasetron Mesylate), 100 mg, bottles of 
5 tablets, Rx anti-nauseant and anti-emetic.  NDC #0088-
1203-05.  Recall #D-093-0.
CODE
Lot Numbers:  3001616 EXP 2/01, 3003145 EXP 2/01, and 
3003148 EXP 4/01.
MANUFACTURER
Hoechst Marion Roussel, Inc., Cincinnati, Ohio.
RECALLED BY
Manufacturer, by letter on October 5, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Ohio and Missouri.
QUANTITY
10,329 bottles were distributed.
REASON
Stability (6 month) test failure elevated degradation 
product.
_______
PRODUCT
a) Estrone Injectable Suspension, USP, 5 mg/mL, in 10 ml multiple 
dose vials, Rx steriodal estrogen intended for intramuscular 
injection, under the following labels:
NDC 0677-0274-21 (United Research Laboratories)
NDC 57699-041-10 (A&G Pharmaceuticals)
b) Gentamicin Sulfate Injection, 40 mg/mL, 20 mL vial, Rx sterile 
aqueous solution for parenteral injection, under the following 
labels:  NDC 0402-0559-20 (Steris Laboratories)
NDC 0182-1424-65 (Goldline Laboratories)
NDC 0536-4690-73 (Rugby Laboratories).  Recall #D-094/095-0.
CODE
Lot Numbers: a) 98B250 EXP 2/01; b) 98B760 EXP 2/01, and 98D940 
4/01.
MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY
Manufacturer, by letter sent on April 23, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
a) New Jersey, Indiana; b) Nationwide and Puerto Rico.
QUANTITY
a) 30,033 vials; b) 35,234 vials were distributed.
REASON
Current good manufacturing practice deviations: Lack of annual 
stability data.
________
PRODUCT
Klonopin (brand of Clonazepam) Tablets, 0.5 mg, 1 mg, and 2 
Mg, distributed in bottles of 100 tablets and cartons 
each: a) Klonopin (Clonazepam) tablets, 0.5 mg, 25 and 
100 tablet units:
b) Klonopin (Clonazepam) tablets, 1 mg, 25 and 100 tablet 
units;
c) Klonopin (Clonazepam) Tablets, 2 mg, 25 and 100 tablet 
units.  Recall #D-097/099-0.
CODE
All lots. NDC 0004-0068-01, 0004-0068-50, 0004-0058-01, 
0004-0058-50, 0004-0098-01 AND 0004-0098-50.
MANUFACTURER
Roche Pharma, Inc., Humacao, Puerto Rico.
RECALLED BY
Roche Laboratories, Inc., Nutley, New Jersey, by letter 
on August 3, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 48,706 pieces of all three strengths 
combined were distributed.
REASON
Impurity level exceeds specification.
________
PRODUCT
Duratuss G Tablets, (Guaifensin), 1200 mg, in 500 tablet 
bottles, Rx 12-hour sustained release expectorant.  
Recall #D-100-0.
CODE
Lot Numbers:  J980726A and J9800727A.
MANUFACTURER
Mikart, Inc., Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone on June 22, 1999, and by 
letter on June 23, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Wisconsin.
REASON
Dissolution failure.
________
PRODUCT
Koleprin DM Caplets, in 30 caplet bottles, OTC prompt 
release, cough and cold medication.
NDC #0927-018-07.  Recall #D-101-0.
CODE
Lot #98603 EXP 2/01.
MANUFACTURER
SSS/Pfeiffer Pharmaceuticals, Inc., Atlanta, Georgia.
RECALLED BY
Manufacturer, by letter on June 14, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,659 units were distributed; firm estimated that 2,540 
units remained on market at time of recall initiation.
REASON
Friability failure (at 3 month stability).
________
PRODUCT
Streptomycin Sulfate, USP, bulk, in 5 kg fiber drums, Rx for 
manufacturing use only.  Recall #D-105-0.
CODE
Lot Numbers:  SC-SM980802, SC-SM 980701, SC-SM980203,
SC-SM980204, SC-SM980205.
MANUFACTURER
Long March Pharmaceutical Plant, Leshan, Sichuan, Peoples 
Republic of China.
RECALLED BY
Helm New York, Inc., Piscataway, New Jersey, by telephone between 
September 8 and 16, 1999, followed by letter.  Firm-initiated 
recall ongoing.
DISTRIBUTION
New York, New Jersey, Ohio, Missouri, Arkansas, North Carolina, 
Iowa, California.
QUANTITY
780 kg. were distributed; firm estimated that 25 kg remained on 
market at time of recall initiation.
REASON
Current good manufacturing practice deviations (at manufacturing 
site in China).
________
PRODUCT
Aldoril D50 Tablets, (Methyldopa (500mg)-Hydro-
chlorothiazide (50mg)), in 100 Tablet bottles, Rx used to 
control hypertension. NDC #0006-0935-68 
Recall #D-106-0.
CODE
Lot Numbers:  B5511 EXP 1/00, D5714 EXP 4/00, D5719 EXP 
4/00, E6156 EXP 4/00, E6172 EXP 2/00, H3896 EXP 4/00.
MANUFACTURER
Merck and Company, Inc., West Point, Pennsylvania.
RECALLED BY
Manufacturer, by letter dated September 23, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
15,424 bottles were distributed.
REASON
Dissolution failure for Hydrochlorothiazide.
________
PRODUCT
Hibistat Germicidal hand rinse, (Chlorhexidine 
gluconate), 0.5% w/w, OTC, used by health care 
professional as a germicidial hand rinse. 
NDC #0310-0575-08.  Recall #D-107-0.
CODE
Lot #3152B EXP 4/01.
MANUFACTURER
Accupac, Inc., Mainland, Pennsylvania.
RECALLED BY
AstraZeneca, a business unit of Zeneca, Inc., Wilmington, 
Delaware, by letter on October 14, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and Saudi Arabia.
QUANTITY
33,432 bottles were distributed.
REASON
Alcohol low potency and specific gravity failure; rework 
without current good manufacturing practice control.
________
PRODUCT
Spectinomycin Dihydrochloride Pentahydrate, Bulk Drug 
Substance, Rx non-sterile special grade bulk antibiotic. 
 Recall #D-110-0.
CODE
Lot Numbers:  53-049-CD, 53-059-CD, 53-060-CD, 
53-061-CD, 53-085-CD, 53-086-CD, 53-087-CD,
53-088-CD and 54-188-CD.
MANUFACTURER
Abbott Laboratories, Inc., Chemical and Agricultural 
Products Division, North Chicago, Illinois.
RECALLED BY
Manufacturer, by letter dated October 1, 1999, and by 
telephone on October 4, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Italy, Switzerland, France, Hong Kong, Korea, Taiwan.
QUANTITY
4,459.04-kg of bulk drug substance were distributed.
REASON
Iron contamination.
________
PRODUCT
Warrick Pharmaceuticals brand of Albuterol, USP, Inhalation 
Aerosol, 17 g, 200 metered inhalations, Rx for the prevention and 
relief of bronchospasm. NDC: 59930-1560-1
NDC: 59930-1560-2 (Batch 9-BBS-551 only, batch package without 
mouthpiece as a refill presentation).
Recall #D-111-0.
CODE
Batch        Expiry
9-BBS-540    3/01
9-BBS-548    4/01
9-BBS-549    4/01
9-BBS-550    4/01
9-BBS-551    4/01
9-BBS-552    4/01
9-BBS-553    4/01
9-BBS-554    4/01
9-BBS-555    4/01
9-BBS-556    4/01
9-BBS-557    5/01
9-BBS-558    5/01
9-BBS-559    5/01
9-BBS-560    5/01
9-BBS-561    5/01
9-BBS-562    5/01
9-BBS-563    5/01
9-BBS-564    5/01
9-BBS-565    5/01
9-BBS-566    5/01
9-BBS-567    5/01
9-BBS-568    5/01
9-BBS-569    5/01
9-BBS-570    5/01
9-BBS-572    6/01
9-BBS-573    6/01
9-BBS-574    6/01
9-BBS-811    2/01
9-BBS-817    4/01
9-BBS-818    4/01
9-BBS-819    4/01
9-BBS-820    4/01 
MANUFACTURER
Schering Laboratories, Inc., Kenilworth, New Jersey.
(Note: Warrick Pharmaceuticals Corp. is the generic 
pharmaceutical marketing subsidiary of Schering Plough 
Corporation).
RECALLED BY
Manufacturer, by letter mailed September 7 through 14, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
Batch Number        Quantity Shipped(Units)
9-BBS-540            192,582
9-BBS-548            190,935
9-BBS-549            194,760
9-BBS-550            190,740
9-BBS-551            145,522
9-BBS-552            187,689
9-BBS-553            190,337
9-BBS-554            186,336  
9-BBS-555            186,870  
9-BBS-556            187,698  
9-BBS-557            187,920  
9-BBS-558            189,288  
9-BBS-559            188,352  
9-BBS-560            190,752  
9-BBS-561            191,652  
9-BBS-562            186,984  
9-BBS-563            190,254  
9-BBS-564            188,825  
9-BBS-565            188,784  
9-BBS-566            189,070 
9-BBS-567            185,303  
9-BBS-568            184,968  
9-BBS-569            190,080  
9-BBS-570            188,519
9-BBS-572            107,472
9-BBS-573            104,939 
9-BBS-574             23,642  
9-BBS-811             23,448  
9-BBS-817            109,016
9-BBS-818            108,846 
9-BBS-819            109,077  
9-BBS-820            107,064  
REASON
Insert mislabeling; insert incorrectly instructs user to 
only use with orange mouth piece, while product is 
accompanied by white mouthpiece, the correct color.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Platelets, Pheresis.  Recall #B-143-0.
CODE
Unit Numbers: 19235-6459-01, 19235-6459-02, 19235-3178-01, 19235-
3178-02, 19236-1495-01, 19236-1495-02.
MANUFACTURER
United Blood Services, Reno, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on 
December 21, 1998, and by letters dated January 8, 1999.
DISTRIBUTION
Nevada.
QUANTITY
6 units were distributed.
REASON
Blood products had high platelet counts.
________
PRODUCT
Platelets.  Recall #B-146-0.
CODE
Unit #22KY31021.
MANUFACTURER
American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on April 12, 1999, and by letter dated 
April 16, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with the incorrect ABO group.
________
PRODUCT
Red Blood Cells, Frozen.  Recall #B-149-0.
CODE
Unit #5566482.
MANUFACTURER
Naval Hospital Blood Bank, Jacksonville, Florida.
RECALLED BY
Manufacturer, by facsimile on October 19, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood tested negative for the hepatitis B surface antigen 
(HBsAg), but was collected from a donor who previously tested 
reactive for HBsAg, with no confirmatory testing.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Recovered Plasma.  Recall #B-150/153-0.
CODE
Unit Numbers:  a) 22KT11794, 22FQ38860; b) 22KT11794;
c) 22KT11794; d) 22KE92044.
MANUFACTURER
American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY
Manufactuer, by letters dated September 8, 1999 or January 29, 
1999, and October 8, 1998, telephone on September 1, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Pennsylvania, New Jersey, Texas, Switzerland.
QUANTITY
a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit.
REASON
Blood products, collected from three donors with a history of 
having tested positive for hepatitis.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. 
 Recall #B-154/156-0.
CODE
Unit numbers:  a) 19033-3563, 19226-8287; b) 19226-8287;
c) 19033-3563.
MANUFACTURER
United Blood Services, Reno, Nevada.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated 
December 22, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Nevada and Switzerland.
QUANTITY
a) 2 units; b) 1 unit; c) 1 unit was distributed.
REASON
Blood product were collected from a donor with a history of 
hepatitis.
________
PRODUCT
a) Red Blood Cells; b) Source Leukocytes; c) Recovered Plasma.  
Recall #B-161/163-0.
CODE
Unit #53LL21809.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by letters dated January 25, 1999 and February 25, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Maryland, New Jersey, California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who lived in a 
household with someone who had tested positive for HIV and 
Hepatitis B.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Platelets; d) 
Platelets for Further Manufacture; e) Recovered Plasma.
Recall #B-180/184-0.
CODE
Unit Numbers: a) 2214742, 2216330; b) 2214742; c) 2214742;
d) 2216330 ;e) 2216330.
MANUFACTURER
Central Florida Blood Bank, Inc., Orlando, Florida.
RECALLED BY
Manufacturer, by letter dated December 21, 1995.  Firm-initiated 
recall complete.
DISTRIBUTION
Florida.
QUANTITY
a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 1 unit.
REASON
Blood products tested negative for the antibody to the human 
immunodeficiency virus type 1 (HIV-1), but were collected from a 
donor who previously tested repeatedly reactive for the antibody, 
Western Blot negative.
_______
UPDATE
Recall #B-013/014-0, Red Blood Cells, Irradiated and Whole Blood, 
Irradiated (Coffee Memorial Blood Center, Inc., Amarillo, Texas), 
which appeared in the October 27, 1997 Enforcement Report is 
being rescinded because it is a duplicate of Recall #B-807/808-9.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
IMED Gemini PC-4 Volumetric Infusion Pump and Controller with 
Version 1.85 Software:
a) PC-4 Infusion Pump, Model 1340, 110 volts;
b) PC-4 Infusion Pump, Model 1341, 220 volts.
Recall #Z-174/175-0.
CODE
All pumps that carry software version 1.85.
MANUFACTURER
Alaris Medical Systems, Inc., San Diego, California.
RECALLED BY
Manufacturer, by letter on September 22, 1999.  Firm-initiated 
field correction ongoing.
DISTRIBUTION
Nationwide and International.
QUANTITY
4,753 (model 1340, 110 volts) and 132  (model 1341, 220 volts) 
pumps were distributed.

REASON
Due to a software modification, the devices will stop infusing 
and alarm if the processors receive conflicting or confusing 
messages.
________
PRODUCT
Maxxim Medical Custom Tray Kits containing DeRoyal Light Handle 
Covers:
a) Custom Tray Models, containing DeRoyal       Non-sterile, 
Model No. 26-011-NS SAF-T-GRIP Light Handle Covers;
Custom Tray Models, containing DeRoyal  Sterile, Model No. 26-012 
Light Handle Covers.  Recall #Z-211/212-0.
CODE
GROUP 1. 
5,100 LIGHT HANDLE COVERS, OF VARIOUS DEROYAL LOT NUMBERS 
DESIGNATED WITH THE DEROYAL PART NUMBER AND NAME," 26-011NS 
COVER, LIGHT HANDLE/ SAF-T-GRIP".  3,364 OF THESE HANDLE COVERS 
WERE INCORPORATED INTO 1,796 PRODUCTS BY MAXXIM UNDER THE MODEL 
NUMBERS AND LOT NUMBERS SHOWN BELOW. THE PRODUCTS IN THIS GROUP 
WERE SENT TO SEVEN CONSIGNEES IN SEVERAL STATES. EACH PRODUCT MAY 
CONTAIN FROM 1 TO 4 LIGHT HANDLE COVERS.
MODEL BAC375B                LOT 69060645
MODEL BAC376C                LOT 69060243
MODEL CVC378E                LOT 69050844 & 69051000
MODEL GSC377D                LOT 69060813
MODEL LZC380D                LOT 69061316
MODEL OPC369                 LOT 69060802
MODEL OPC383F                LOT 69060387
MODEL GSM396B                LOT 69060791
MODEL OBK314D                LOT 69060202
MODEL OBK547D                LOT 69061045
MODEL GSS515B                LOT 69070159
MODEL LZS813C                LOT 69061306
MODEL CVN758                 LOT 69060918
MODEL GSM542C                LOT 69061343
MODEL GSM543B                LOT 69061081
MODEL OPM548D                LOT 69060335
MODEL OPM549C                LOTS 69060134 & 69060235
GROUP 2.
CONSISTS OF 1080 LIGHT HANDLE COVERS RECEIVED FROM DEROYAL UNDER 
VARIOUS DEROYAL LOT NUMBERS AND BEAR THE DEROYAL NAME AND CATALOG 
NUMBER, "COVER LIGHT HANDLE STR 2'S, #26-012". 656 OF THESE LIGHT 
HANDLE COVERS WERE PACKED INTO 636 PRODUCTS. THESE WERE SENT TO 
ONLY ONE CONSIGNEE/HOSPITAL. EACH KIT CONTAINS 1 OR 2 LIGHT 
HANDLE COVERS. 
MODEL CVT022   LOT 69060406               BASIN CV PACK
MODEL GST013   LOT 69060773               MAJOR PACK
MODEL GST018   LOT 69060189               MINOR  PACK
MODEL LZT012   LOT 69060115               LAP CHOLE PACK
MODEL NRT016   LOT 69060116               NEURO BACK PACK
MODEL NRT021   LOT 69061115               CHRANI PACK
MODEL OPT014   LOTS 69060423 & 69070106   ORTHO EXTREMITY
                                          PACK
MODEL OPT015   LOT 69050584               SHOULDER PACK
MODEL OPT015A  LOT 69060514               SHOULDER PACK   
MODEL OPT019   LOTS 69060281 & 69070034   FRACTURE TABLE
                                          PACK
MODEL OPT024   LOT 69060424               TOTAL HIP PACK
MANUFACTURER
DeRoyal Surgical, Inc., Powell, Tennessee (component supplier).
RECALLED BY
Maxxim Medical, Temecula, California, by letter dated August 3, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Arizona, California, Idaho, Montana, New Mexico, Texas.
QUANTITY
4066
REASON
The light handle covers have the potential to fall off the light 
handle or split during use.
________
PRODUCT
Promotional Material for TAB250 Mouse Anti-HER2[c-erbB-2] 
Antibody.  Recall #Z-213-0
CODE
Immunochemica Newsletter Vol. 11, No. 1
Immunochemica Newsletter Vol. 11, No. 2 
V-Liner Mailer
HER2 Flyer
Labels and Specification Sheet:
Catalog No. 28-0003, Lot No. 9034624
MANUFACTURER
Zymed Laboratories, Inc., South San Francisco, California.
RECALLED BY
Manufacturer, by letters:  promotional material on November 12, 
1999; label and specification sheet on November 10, 1999  Firm-
initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
33,659 promotional material and 38 label & specification sheets 
were distributed.
REASON
Devices were labeled for an intended use not included in the 
existing 510(k) or PMA.
________
PRODUCT
3M Sarns Brand Myocardial Protection Sets in clear plastic trays, 
indicated for delivery of cardioplegic solutions to the heart 
during cardiopulmonary bypass surgery:
1.  Conducer Cardioplegia Set with MP-4, 4:1 ratio, no 
recirculation.  Catalog #: 165720 Product Order #: 98-0702-0012-
0.  Lots:  W504044, W503670, W502672, W502889, W502825, W502931, 
W503155, W503265, W503014, W503573, W503408, W504193.
2.  Integrated Cardioplegia Delivery System Blood Mix 
Cardioplegia Disposable Tubset.  Catalog #: 14915 Product Order 
#:  98-0702-0108-6 Lots:  W503643, W503311, W502914, W503419, 
W503095.
3.  MP-4 Clear Cardioplegia Set Recirculation from the Cannula 
Connection.  Catalog #: 15486 Product Order #: 98-0702-0123-5 
Lots:  W503231, W503503, W502742, W503099, W502917.
4.  MP-4 Clear Cardioplegia Set Recirculation for the Monitor 
Module.  Catalog #: 15501 Product Order #: 98-0702-0125-0 Lots:  
W503642, W503866, W503151, W502740, W503360, W503405, W502951, 
W504284.
5.  MP-4 Blood Cardioplegia Set 4:1 Ratio, Recirculation from the 
Cannula Connection.  Catalog #: 15928 Product Order #:  98-0702-
0139-1 Lot:  W503042.
6.  MP-4 Blood Cardioplegia Set 4:1 Ratio, No Recirculation.  
Catalog #: 16010 Product Order #: 98-0702-0142-5 Lots:  W503784, 
W503394, W503682, W503111, W503260, W503479, W503623, W502829, 
W502993, W504097, W504161.
7.  MP-4 Clear Cardioplegia Set Filtered Recirculation from the 
Monitor Module.  Catalog #: 16010 Product Order #: 98-0702-0143-3 
Lots:  W503020, W503229, W502870, W503454.
8.  MP-4 Clear Cardioplegia Set Filtered Recirculation from the 
Cannula Connection.  Catalog #: 16015 Product Order #: 98-0702-
0012-0 Lot: W503248.
9.  Custom MP-4 Hackensack Medical Center.  Catalog #: N/A 
Product Order #: 98-0702-0153-2 Lots: W503681, W503113, W503471, 
W503361, W502833, W504045.
10.  MP-4 Blood Cardioplegia Set 2:1 Ratio, No Recirculation.  
Catalog #: 16200 Product Order #: 98-0702-0224-1 Lots:  W503621, 
W502721, W502990.
11.  Conducer Cardioplegia Set 4:1 Ratio, No Recirculation.  
Catalog #: 9457 Product Order #: 98-0702-0344-7 Lots: W503634, 
W503364, W503439, W503439, W502984, W504080.
12.  Conducer Cardioplegia Set with MP-4, 2:1 Ratio, No 
Recirculation.  Catalog #: 9499 Product Order #: 98-0702-0554-1 
Lots:  W503956, W503358, W502915, W503590, W504150.
13.  Custom MP-4 Conducer Rochester General.  Catalog #: N/A 
Product Order #: 98-0702-0594-7 Lots: W504030, W50337, W503722, 
W503864, W503489, W502846, W503050, W504269.
14.  Conducer Cardioplegia Set 1:1 Ratio, No Recirculation.  
Catalog #: 4414 Product Order #: 98-0702-0630-9 Lots: W502926, 
W502675, W503451, W502847.
15.  Conducer Cardioplegia Set with MP-4 8:1 Ratio, No 
Recirculation.  Catalog #: 4459 Product Order #: 98-0702-0656-4 
Lots: W503717, W503200, W503594, W503362, W502731, W504152.
16.  Custom MP-4 St Luke抯 Hospital.  Catalog #: N/A Product 
Order #: 98-0702-0686-1 Lots: W503770, W503309, W502874, W504076.
17.  Custom Conducer Houston Life Support.  Catalog #: N/A 
Product Order #: 98-0702-0720-8 Lots: W503392, W502832.
18.  Custom MP-4 Conducer Hill.  Catalogn #: N/A Product Order #: 
98-0702-0723-2 Lots: W503352, W503135, W503710.
19.  Custom MP-4 Conducer Presbyterian New York.  Catalog #: N/A 
Product Order #: 98-0702-0756-2 Lots: W503583, W503407, W502928, 
W503258.
20.  Custom 4:1 Hackensack Medical Center.  Catalog #: N/A 
Product Order #: 98-0702-0760-4 Lots: W504074, W503660, W502863, 
W503022, W503421.
21.  Custom Conducer 8:1 Sacred Heart Hospital.  Catalog #: N/A 
Product Order #: 98-0702-0845-3 Lots: W503661, W503143, W503452, 
W502848.
22.  Custom MP-4 Conducer CPMC Ozomiser Infusion System. Catalog 
#: N/A Product Order #: 98-0702-0955-0 Lot: W502788.
23.  Conducer Cardioplegia St with Bridge 4:1, No Recirculation. 
 Catalog #: 6376 Product Order #: 98-0702-0966-7 Lots: W503150, 
W502708, W503403, W503601, W503232, W502950, W504159.
24.  Conducer Cardioplegia Set with PM-4 and Bridge 4:1 Ratio, No 
Recirculation.  Catalog #: 6375 Product Order #: 98-0702-0967-5 
Lots: W504040, W503882, W503830, W503480, W503591, W503202, 
W503266, W503404, W503052, W503635, W502730, W504242, W504288, 
W504148.
25.  Custom MP-4 Conducer B Trap, Pump Recirculation 4/cs.  
Catalog #: N/A Product Order #: 98-0702-0969-1 Lots: W503910, 
W502804.
26.  Customized:Bld, Conducer B Trap, Pump Recirculation 4/cs.  
Catalogn #: N/A Product Order #: 98-0702-1005-3 Lots: W503356.
27.  Conducer Cardioplegia Set Low-Prime 4:1 Ratio.  Catalog #: 
5852 Product Order #: 98-0702-1022-8 Lots: W503338, W502676, 
W502918.
28.  Custom MP-4 Conducer 8:1 with Bridge Perfusion Products.  
Catalog #: N/A Product Order #: 98-0702-1118-4 Lots: W503217, 
W503547.
29.  Custom MP-4 Houston Life Support SETA.  Catalog #: N/A 
Product Order #: 98-0702-1154-9 Lots: W503295, W502859.
30.  Custom Conducer 4:1 Bridge University of Iowa.  Catalog #: 
N/A Product Order #: 98-0702-1181-2.  Lot W503676.
31.  Customized:MUF,BLD, 4:1 Conducer, B Trap, Bridge 4/cs.  
Catalog #: N/A Product Order #: 98-0702-1209-1 Lots: W503871, 
W503619, W502706, W503336.
32.  Custom Conducer with MP-4 University of Virginia Medical 
Center.  Catalog #: N/A Product Order #: 98-0702-1210-9 Lot: 
W502691.
33.  Customized: Clear Conducer Reverse Flow D.C. 4/cs.  Catalog 
#: N/A Product Order #: 98-0702-1243-0 Lot: W502858.
34.  Customized: Blood 4:1 MP-4 Coil, Pump Recirculation 4/cs.  
Catalog #: N/A Product Order #: 98-0702-1250-5 Lots W503680, 
W503194, W503484, W502912.
35.  Custom MP-4 with Recirculation UPMC.  Catalog #: N/A Product 
Order #: 98-0702-1205-7 Lots: W504031, W503416, W503096, W503555, 
W502771, W504120.
36.  Customized: Blood 4:1 MP-4 Coil 4/cs.  Catalog #: N/A 
Product Order #: 98-0702-1307-3 Lots: W503712, W502741, W502986, 
W503423, W504111.
37.  Custom MP-4 4:1 Ratio with Recirculation Bellin Hospital.  
Catalog #: N/A Product Order #: 98-0702-1420-4 Lots: W504032, 
W503114, W503600, W503355.
38.  Custom MP-4 Clear with Recirculation St Vincent Hospital.  
Catalog #: N/A Product Order #: 98-0702-1441-0 Lots: W503228, 
W502831, W503455.
39.  Customized: Blood 4:1 Conducer Bubble Trap No Recirculation 
4/cs.  Catalog #: N/A Product Order #: 98-0702-1458-4 Lot: 
W503193.
40.  Customized: Blood 4:1 Conducer MP-4 120' Table Line 4/cs.  
Catalog #: N/A Product Order #: 98-0702-1469-1 Lots: W503552, 
W503256.
41.  Customized: Blood 2:1 MP-4 Conducer Bridge.  Catalog #: N/A 
Product Order #: 98-0702-1504-5 Lots: W503440, W502772.
42.  Customized: Blood Conducer Bubble Trap 4/cs.  Catalog #: N/A 
Product Order #: 98-0702-1510-2 Lots: W503192, W502769, W503649, 
W504147.
43.  Customized:  Blood 4:1 Coil Bridge 4/cs.  Catalog #: N/A 
Product Order #: 98-0702-1553-2 Lots: W502999, W502727.
44.  Customized: Blood 4:1 MP-4 B Trap Conducer MUF.  Catalog #: 
N/A Product Order #: 98-0702-1572-2 Lot: W503550.
45.  Customized: Clear MP-4 Coil Double Spike, Recirculation.  
Catalog #: N/A Product Order #: 98-0702-1589-6 Lots: W503620, 
W503911, W503267, W503453, W502739, W503021, W504100.
46.  Customized: Blood 4:1 MP-4 Prelief Conducer Low Prime.  
Catalog #: N/A Product Order #: 98-0702-1594-6 Lots: W503666, 
W502927, W504233.
47.  Customized: Blood 8:1 B Trap Conducer.  Catalog #: N/A 
Product Order #: 98-0702-1672-0 Lots: W502948, W503437, W503677, 
W503067, W504114.
48.  Customized:  Blood 4:1 B Trap Conducer MUF.  Catalog #: N/A 
Product Order #: 98-0702-1679-5 Lots: W503726, W502983, W503585, 
W502770.
49.  Customized: Blood Conducer RFDC Isolater Single Spike.  
Catalog #: N/A Product Order #: 98-0702-1786-8 Lot:  W503796.
50.  Customized: Blood 4:1 Conducer Bubble Trap Filter.  Catalog 
#: Product Order #: 98-0702-1786-8 Lot: W503796.
51.  Customized: Blood 4:1 Conducer Bubble Trap Filter.  Catalog 
#: N/A Product Order #: 98-0702-1789-2 Lots: W503917, W502705, 
W503593, W503006, W503789, W503043.
52.  Customized ICDS Blood Set Bridged Table Line.  Catalog #: 
N/A Product Order #: 98-0702-1798-3 Lots: W503255, W503496.
53.  Customized: Conducer B Trap Single Spike MUF.  Catalog #: 
N/A Product Order #: 98-0702-1804-9 Lot: W502716.
54.  Customized: Blood 4:1 Bridge MP-4 Coil Prelief 4/cs.  
Catalog #: N/A Product Order #: 98-0702-1819-7 Lots: W502723, 
W503000, W503195.
55.  Customized:  Blood 4:1 Conducer MP-4 Prelief 4/cs.  Catalog 
#: N/A Product Order #: 98-0702-1850-2 Lots: W503438, W503297, 
W503718.
56.  Customized: Blood 4:1 Bridge Coil MP-4 Double Spike 4/cs.  
Catalog #: N/A Product Order #: 98-0702-1859-3 Lots: W503870, 
W503595.
57.  Customized: Conducer Low Prime 4/cs.  Catalog #: N/A Product 
Order #: 98-0702-1862-7 Lot:  W503597.
58.  Customized: Blood 4:1 B Trap Conducer Bridge.  Catalog #: 
N/A Product Order #: 98-0702-1877-5 Lots: W503932, W504070, 
W504144.  Recqall #Z-214-0.
CODE
See above.  All sets in clear plastic trays are under recall.  
Products have a three year expiry period.
MANUACTURER
Terumo Cardiovascular Systems Corporation, Ann Arbor, Michigan.
RECALLED BY
Manufacturer, by letter dated September 22, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
34,756 units were distributed.
REASON
Seals between the tyvek lid and the clear plastic tray are 
inadequate resulting in poor seal integrity, thereby compromising 
the sterility of the devices.

RECALLS AND FIELD CORRECTIONS:VETERINARY PRODUCTS--CLASS 
III
_______
PRODUCT
Blue Paw Print Cat/Dog Dish, in 4 sizes:  5, 6. 7.5, and 9 
inches; Green Paw Print Cat/Dog Dish, in 4 sizes: 5, 6, 7.5, and 
9.5 inches.  Recall #V-051-0.
CODE
Each product is identified by a barcode number printed on a 
sticker label which is attached on the bottom bowl or dish.  Each 
also has a SKU number which is printed on the small cardboard 
box.  The following are the SKU numbers and bar code numbers for 
each of products: 
SKU#      Name of Product                Barcode #
446289    BLUE PAW PRINT CAT DISH 5"     772583446287
446297    BLUE PAW PRINT DOG BOWL 6"     742583446294
446300    BLUE PAW PRINT DOG BOWL 7.5"   742583446300
446319    BLUE PAW PRINT DOG BOWL 9.5"   742583446317
446246    GREEN PAW PRINT CAT DISH 5"    742583446249
446254    GREEN PAW PRINT DOG BOWL 6"    742583446256
446262    GREEN PAW PRINT DOG BOWL 7.5"  742583446263
446270    GREEN PAW PRINT DOG BOWL 9.5"  742583446270.
MANUFACTURER
Chiao Zhou, Guangdong, China.
RECALLED BY
PetCo Animal Supplies, Inc., San Diego, California, by memoranum 
dated May 16, 1999, and June 4, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Nationwide.
QUANTITY
202,032 units were distributed.
REASON
Product contained excessive levels of lead.

END OF ENFORCEMENT REPORT FOR DECEMBER 1, 1999.  BLANK PAGES MAY 
FOLLOW.

####