FDA

Enforcement Report

July 28, 1999                                     99-30

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
"Sprouting Clover" Clover Seeds, packaged in 3 ounce resealable 
clear plastic bags. Product is sold in 1999-2000 Pinetree Garden 
Seeds catalog as sprouting seeds, page 56, item number SP9 and as 
part of a "Sprouting for Health Gift" Set, page 167, item number 
PG7.  Recall #F-567-9.
CODE
SP9 Packed for 1999.  Product sold from 11/98 to 6/9/99.
MANUFACTURER
Dover Sales Company, Inc., Piedmont, Oklahoma (supplier).
RECALLED BY
Pinetree Garden Seeds, New Gloucester, Maine (repacker), by 
letter beginning June 16, 1999, and by press release on June 10, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
1,000 packets were distributed.
REASON
Product may be contaminated with Salmonella Typhimurium.  These 
seeds were from the same lot as the seed lot associated with an 
outbreak of Salmonella Typhimurium in Colorado.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
________
PRODUCT
Rowasa Rectal Suppositories (Mesalamine, 500 mg), in cartons of 
12, 24, and physician sample of 2's, Rx indicated for the 
treatment of active ulcerative proctitis.  Recall #D-282-9.
CODE
All lot numbers remaining within expiration date.
MANUFACTURER
G&W Laboratories, Plainfield, New Jersey (contract manufacturer).
RECALLED BY
Solvay Pharmaceuticals, Marietta, Georgia, by letter mailed on 
May 18, 1999, and by voice mail on May 11, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
307,137 cartons of 12; 254,946 cartons of 24;and 100,281 
pyhysician samples were distributed.
REASON
Dissolution failure and/or lack of assurance of stability through 
labeled expiry date.
________
PRODUCT
M.V.I. Pediatric, multi-vitamins for infusion, in single dose 10 
Ml vials.  NDC #0186-1839-31.  Recall #D-283-9.
CODE
Lot #813011 EXP 7/99.
MANUFACTURER
Catalytica Pharmaceuticals, Inc., Greenville, North Carolina.
RECALLED BY
AstraZeneca LP, Westborough, Massachusetts, by letter on July 2, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
8,392 were manufactured; firm estimated that 5-10 percent 
remained on market at time of recall initiation.
REASON
Folic acid and Vitamin B12 levels below potency specification 
prior to expiration.
________
PRODUCT
Nystatin Oral Suspension, USP, 100,000 units per Ml, Fruit 
Flavored, Rx in 2 ounce and 1 pint units, used for the treatment 
of candidiasis of the oral cavity, under the Morton Grove, NDC 
#60432-537-16 & 60432-537-60, and Schein labels, NDC #0364-2075-
58;
b) Generlac Solution (Lactulose Solution, USP), 10g/15Ml, for 
oral or rectal administration, Rx in one pint (473 Ml) 
containers, an Rx oral colonic acidifier for the prevention and 
treatment of portal-systemic encephalopathy, under the Morton 
Grove label.  NDC #60432-038-16.
Recall #D-184/285-9.
CODE
Lot numbers:  a) 21533, 21720, 21776, 22118, 22325, 21616 and 
22279; b) 21767.
MANUFACTURER
a) Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois; b) 
Morinaga Milk Industry Company, Ltd., Tokyo, Japan.
RECALLED BY
Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois, by 
letter dated June 14, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 26,136 pints and 50,263 2-fluid ounce bottles were 
distributed; b) 21,105 pints were distributed; firm estimated 
that 10 percent of product remained on market at time of recall 
initiation.
REASON
Microbial contamination (acinetobacter baumanii).
________
PRODUCT
Prednisolone Acetate Ophthalmic Suspension, USP, Sterile, 1%, in 
10Ml units, under the Alcon (NDC #0998-0637-05) and Falcon (NDC 
#61314-637-10) labels.  Recall #D-286-9.
CODE
Lot numbers: 57984P and 58005P.
MANUFACTURER
Alcon (Puerto Rico), Inc., Humaco, Puerto Rico.
RECALLED BY
Alcon Laboratories, Inc., Fort Worth, Texas, by letter mailed on 
June 3, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
64,175 units were distributed.
REASON
Loose clumping (agglomeration) of active ingredient.
________
PRODUCT
Atenolol Tablets USP packaged in: a) 25 mg; b) 50 mg;
c) 100 mg.  All three strengths were packaged and distributed in 
bottles of 100's and 1000's, Rx used in the management of 
hypertension.  NDC Numbers: 25 mg: Bottle of 100, NDC 0005-3218-
43 Bottle of 1000  NDC 0005-3218-34 
50 mg: Bottle of 100 NDC 0005-3219-43 Bottle of 1000
NDC 0005-3219-34 100 mg: Bottle of 100  NDC 0005-3220-43 
Bottle of 1000 NDC 0005-3220-34.  Recall #D-287/289-9.
CODE
a) 25 mg, Bottles of 100:
D454-909 (EXP 03/01)
D454-910 (EXP 03/01)
D457-101 (EXP 06/01)
D457-102 (EXP 06/01)
D457-103 (EXP 06/01)
D459-493 (EXP 09/01)
D459-386 (EXP 09/01)
D459-390 (EXP 09/01)
25 mg, Bottles of 1000:
D457-100 (EXP 06/01)
D457-104 (EXP 06/01)
D459-385 (EXP 09/01)
D459-387 (EXP 09/01)
D459-389 (EXP 09/01)
c) 50 mg, Bottles of 100:
D449-230 (EXP 07/00)
D453-456 (EXP 02/01)
D453-457 (EXP 02/01)
D457-107 (EXP 06/01)
D459-404 (EXP 09/01)
b) 50 mg, Bottles of 1000:
D449-040 (EXP 07/00)
D449-041 (EXP 07/00)
D449-042 (EXP 07/00)
D449-228 (EXP 07/00)
D449-229 (EXP 07/00)
D449-231 (EXP 07/00)
D451-212 (EXP 10/00)
D451-213 (EXP 10/00)
D451-318 (EXP 10/00)
D451-319 (EXP 10/00)
D453-453 (EXP 02/01)
D453-454 (EXP 02/01)
D453-455 (EXP 02/01)
D457-105 (EXP 06/01)
D457-106 (EXP 06/01)
D457-108 (EXP 06/01)
D458-707 (EXP 06/01)
D457-110 (EXP 06/01)
D457-111 (EXP 07/01)
D457-112 (EXP 07/01)
D457-113 (EXP 07/01)
D457-114 (EXP 07/01)
D459-398 (EXP 09/01)
D459-400 (EXP 09/01)
D459-402 (EXP 09/01)
D460-390 (EXP 10/01)
D460-391 (EXP 10/01)
D460-392 (EXP 10/01)
c) 100 mg, Bottles of 100:
D459-520 (EXP 09/01)
D459-521 (EXP 09/01)
D461-521 (EXP 01/02)
100 mg, Bottles of 1000:
D449-233 (EXP 07/00)
D457-115 (EXP 07/01)
D457-116 (EXP 07/01)
D457-117 (EXP 07/01)
MANUFACTURER
Wyeth-Ayerst Pharmaceuticals, Inc., Pearl River, New York.
RECALLED BY
Wyeth-Ayerst Laboratories, Richmond, Virginia, by letter sent on 
June 16, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Puerto Rico, Virgin Islands, Taiwan.
QUANTITY
583,586 bottles were distributed August 1997 to May 1999 as 
follows: 
a) 25 mg: 347,824 bottles total: 330,463 bottles of 100 and 
17,361 bottles of 1000 
b) 50 mg: 196,773 bottles total: 126,098 bottles of 100 and 
70,675 bottles of 1000 
c) 100 mg: 38,989 bottles total: 33,919 bottles of 100 and 5,070 
bottles of 1000.
REASON
Content uniformity failure.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-1006/1007-9.
CODE
Unit #X15811.
MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY
Manufacturer, by telephone on May 18, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit.of each component was distributed.
REASON
Blood products tested negative for the antibody to the human T-
lymphotropic virus type I and II (anti-HTLV-I/II), but were 
collected from a donor who previously tested repeatedly reactive 
for anti-HTLV-1/II
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-1016/1018-9.
CODE
Unit #6066018.
MANUFACTURER
LifeSource, Glenview, Illinois.
RECALLED BY
Manufacturer, by telephone on April 14 or 15, 1999, and by 
letters dated April May 7, 1998, and April 8, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had used 
injectable drugs.
________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. 
 Recall #B-1019/1021-9.
CODE
Unit #21GC42843.
MANUFACTURER
American Red Cross Blood Services, Portland, Oregon.
RECALLED BY
Manufacturer, by telephone on March 24, 1999, followed by letter 
dated March 29, 1999, and by fax on March 25, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Arizona, Washington state, Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor whose husband had sex 
with another male.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Source Leukocytes;
d) Recovered Plasma.  Recall #B-1029/1032-9.
CODE
Unit numbers:  a) 01KF32527, 01KG38402, 01KG38403
b)01KF32527; c) 01KF32527, 01KG38402, 01KG38403;
d) 01KG38402, 01KG38403.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by telephone on December 11, 1997, and by letters 
dated January 16, 1998.  Firm-initaited recall ongoing.
DISTRIBUTION
New York, Georgia, New Jersey, California.
QUANTITY
a) 3 units; b) 1 unit; c) 3 units; d) 2 units were distributed.
REASON
Blood products were incorrectly tested for syphilis.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.  
Recall #B-1036/1037-9.
CODE
Unit #39KJ06934.
MANUFACTURER
American Red Cross, Huntington, West Virginia.
RECALLED BY
Manufacturer, by letter dated March 2, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
West Virginia and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of 
cancer.
________
PRODUCT
Red Blood Cells.  Recall #B-1041-9.
CODE
Unit numbers: 32LG00461, 32LG00465, 32LG00467.
MANUFACTURER
American Red Cross Blood Services, Madison, Wisconsin.
RECALLED BY
Manufacturer, by letters dated November 18, 1998, and January 7, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Illinois and Oklahoma.
QUANTITY
3 units were distributed.
REASON
Blood products were prepared from overweight units of Whole 
Blood.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Removed;
c) Platelets; d) Cryoprecipitated AHF.  
Recall #B-1048/1051-9.
CODE
Unit numbers:  a) 6714613, 6719421, 6746177, 6762700, 7631101, 
7631192; b) 6713880; c) 6713880, 6746177;
d) 6714613, 6787775.
MANUFACTURER
New York Blood Services (Center West), New York, New York.
RECALLED BY
New York Blood Center, Inc., New York, New York, by letter dated 
September 8, 1998.  Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
a) 6 units; b) 1 unit; c) 2 units; d) 2 units were distributed.
REASON
Blood products initially tested negative for the Hepatitis B core 
antigen (anti-HBc), but retrospectively tested repeatedly 
reactive for anti-HBc.
________
PRODUCT
Platelets, Pheresis.  Recall #B-1053-9.
CODE
Unit numbers: 01P38557 and 01LZ07358.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by telephone on July 2, 1998, and November 6, 1998. 
 Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
2 units were distributed.
REASON
Blood products had insufficient volumes to support the platelet 
yields.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Plasma.
Recall #B-1054/1056-9.
CODE
Unit #53J45682.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by telephone on December 3, 1998, and by letter 
dated December 7, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Maryland and District of Columbia.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had received an 
experimental vaccine within one year of donation.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells.  Recall #B-998-9.
CODE
21GV03476, 21GV03477, 21GV03478, 21GV03479, 21GV03480, 21GV03481, 
21GV03482, 21GV03483, 21GV03484, 21GV03485, 21GV03486, 21GV03487, 
21GV03488, 21GV03489, 21GV03490, 21GV03491, 21GV03492.
MANUFACTURER
American Red Cross Blood Services, Portland, Oregon.
RECALLED BY
Manufacturer, by telephone on April 7, 1999, followed by letter 
dated April 21, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Oregon, Washington state, Massachusetts.
QUANTITY
17 units were distributed.
REASON
Blood products were labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells.  Recall #B-999-9.
CODE
Unit #21KJ15589.
MANUFACTURER
American Red Cross Blood Services, Portland, Oregon.
RECALLED BY
Manufacturer, by telephone on April 9, 1999, followed by letter 
dated April 21, 1999.  Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who was previously 
deferred for an elevated ALT.
________
PRODUCT
Platelets.  Recall #B-1052-9.
CODE
Unit #0Lle13309.
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by letter dated November 16, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product was distributed after receipt of information 
concerning a post donation illness.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
VIA Low Volume Mode (LVM) Monitor, an in-line beside medical 
device used on volume restricted patients. 
Recall #Z-1041-9.
CODE
Catalog #V-LVMI.  All units.
MANUFACTURER
VIA Medical Corporation, San Diego, California.
RECALLED BY
Manufacturer, by telephone on May 21, 1999, followed by letter.  
Firm-initiated field correction ongoing.
DISTRIBUTION
California, Iowa, Missouri, New Jersey, Texas.
QUANTITY
59 units were distributed.
REASON
The device has a software problem that can cause the monitor, 
under unusual circumstances, to display and print a chemistry 
value from a previous sampling instead of the blood chemistry 
value from the current sampling.
________
PRODUCT
ADVIA 120 Hematology System, a quantitative automated hematology 
analyzer that provides a leukocyte differential count and 
reticulocyte analysis for in-vitro diagnostic use in clinical 
laboratories:  a) Catalog #453-0024-03;
b) Catalog #453-0024-04.  Recall #Z-1073/1074-9.
CODE
All serial numbers.
MANUFACTURER
Bayer Diagnostics Mfg. Ltd., Dublin, Ireland.
RECALLED BY
Bayer Corporation, Elkhart, Indiana, by customer bulletin sent on 
April 30, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 1,000 units.
REASON
When running the ADVIA 120 system in the manual mode using the 
Host Query feature, and the timeout is set to 13 second, it is 
possible for the system to report incorrect patient results.  The 
supplemental labeling instructions section of the product 
labeling instructs users to verify that the correct sample 
identification number appears on the status line before using 
either of the manual samplers.  However, the user is not clearly 
told to review the supplemental operating instructions prior to 
the operation of the system.
________
PRODUCT
ADVIA 120 Hematology System, a quantitative automated hematology 
analyzer that provides a leukocyte differential count and 
reticulocyte analysis for in-vitro diagnostic use in clinical 
laboratories:  a) Catalog 453-0024-03; 
b) Catalog #453-0024-04.  Recall #Z-1075/1076-9.
CODE
All serial numbers.
MANUFACTURER
Bayer Diagnostics Mfg. Ltd., Dublin, Ireland.
RECALLED BY
Bayer Corporation, Elkhart, Indiana, by customer bulletin sent on 
June 15, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 1,000 units.
REASON
The sample needle can be activated while the system is in stand-
by mode during needle chamber cleaning procedure.  Product 
labeling warns that the system must be either off or in the 
stand-by mode to perform routine maintenance, or personal injury 
from the may occur.
________
PRODUCT
Techstar XL Percutaneous Vascular Surgical Device, intended for 
the percutaneous deployment and tying of sutures for surgical 
closure of arterial puncture sites resulting from diagnostic 
catheterization procedures:
a) Model TXL-431-06; b) TXLS-432-06 (Outside the US).
Recall #Z-1085/1086-9.
CODE
All Techstar XL 6 French device produced on or after 2/1/99 
and shipped on or prior to 7/2/99 that were manufactured on 
the Gray, Red, and Purple production lines.
MANUFACTURER
Perclose, Inc., Redwood City, California.
RECALLED BY
Manufacturer, by FedEx letter, fax, and telephone on July 8, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
55,794 units were distributed.
REASON
The needle tips may be misaligned during deployment.
________
PRODUCT
Viscoelastic Systems, indicated for use as a surgical aid in 
anterior segment procedures including cataract extraction and 
intraocular lens implantation:
a) Viscoat Viscoelastic Solution, Catalog No. 8065-1839-05;
b) Duovisc Viscoelastic Systems, Catalog No. 8065-1831-05.
Recall #Z-1088/1089-9.
CODE
Lot Numbers:  a) 57010P, 57443P; b) 57446P.
MANUFACTURER
Alcon Puerto Rico, Inc., Humacao, Puerto Rico.
RECALLED BY
Manufacturer, by letter mailed on June 18, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
36,390 units were distributed.
REASON
The product labeling refers to a Viscoat Cannula Locking Ring 
which is not present in all packages.
________
PRODUCT
Sterile Micro-Kover for Wild, with or without Observer Tubes and 
Photographic System, Part #09-MK953, 40.5 W x 102" L 
(103cmx259cm).  Recall #Z-1094-9.
CODE
Lot #06092C0267.
MANUFACTURER
Advance Medical Designs, Inc., Marietta, Georgia.
RECALLED BY
Manufacturer, by letter on June 2, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
New York , Tennessee, Australia, Portugal.
QUANTITY
420 units were distributed.
REASON
The lot contained open package seals, thereby compromising the 
sterility of the device.
________
PRODUCT
Sterile Micro-Kover for Wild, Part No. 09-MK957, 
54"W x 150"L, with Monocular or Stereo Observer Tubes and 
Photographic System. Recall #Z-1095-9.
CODE
Lot No. 08731C1985.
MANUFACTURER
Advance Medical Designs, Inc., Marietta, Georgia.
RECALLED BY
Manufacturer, by letter mailed on June 2, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Montana, New Jersey Texas, Canada.
QUANTITY
375 units were distributed.
REASON
The lot contained open package seals, thereby compromising the 
sterility of the device.
________
PRODUCT
Sterile Custom Kover, Part No. 08-CC121, 40" x 60" without Rubber 
Band.  Recall #Z-1096-9.
CODE
Lot Numbers: 07267C0572 and 0797C1076.
MANUFACTURER
Advance Medical Designs, Inc., Marietta, Georgia.
RECALLED BY
Manufacturer, by letter on June 2, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Alabama and North Dakota.
QUANTITY
925 units of lot 07267C0572 and 800 0797C1076 units of lot were 
distributed.
REASON
The lots contained open package seals, thereby compromising the 
sterility of the device.
________
PRODUCT
Modified Leveen Needle Electrode, for use in coagulation necrosis 
of soft tissue, Model numbers:  LE212, LE215, LE312, LE315, 
LE3512, LE3515, LE3525.
Recall #Z-1098/1104-9.
CODE
All lots.
MANUFACTURER
Radiotherapeutics Corporation, Mountain View, California.
RECALLED BY
Manufacturer, by letter on June 30, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
2,139 units were distributed.
REASON
Sterility may be compromised as evidenced by a loss of package 
integrity.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Bayer Immuno I Automated Clinical Analyzer Reagents: a) 
Carbamazepine Parameter, intended to measure carbamazepine, an 
anticonvulsant drug, in serum or plasma; b) Valproic Acid 
Parameterm intended to measure valproic acid, an anticonvulsant 
durg in human serum or plasma.
Recall #Z-1070/1071-9.
CODE
a) Catalog No.T01-3677-51, Lots: V23247, V25335 and V29367;
b) Catalog No. T01-3698-01, Lots: V26346, V23428, V08450, V13604, 
V20984 and V31008. 
MANUFACTURER
Dade-Behring, San Jose, California.
RECALLED BY
Bayer Corporation, Elkhart, Indiana, by bulletin sent on April 1 
1999.  Firm-initiated recall ongoing.
DISTRIBUITON
Nationwide and international.
QUANTITY
a) 3,630; b) 3,561 were distributed.
REASON
The above lots do not meet the on-system stability claim.
________
PRODUCT
Bayer Technicon SETpoint Chemistry Calibrator, intended for in-
vitro diagnostic use.  Recall #Z-1072-9.
CODE
Catalog No. T03-1291-62, Lot No. V25757 EXP Sep00;
MANUFACTURER
Bayer Corporation, Business Group Diagnostics, Middletown, 
Virginia.
RECALLED BY
Bayer Corporation, Elkhart, Indiana, by telephone on June 22, 
1999, followed by letter and customer bulletin mailed on June 22, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Michigan, Massachusetts, Missouri, New York, Pennsylvania, 
international.
QUANTITY
Approximately 3,767 units were distributed.
REASON
During review of the value assignment procedure it was learned 
that the operator manually entered intercept corrected SETpoint 
values into an Excel spreadsheet rather than letting the 
spreadsheet calculate the corrections from the true SETpoint.  
The values that were entered were incorrect and, therefore, the 
resulting value assignments were incorrect.
________
PRODUCT
Bayer DCA 2000+ Microalbumin/Creatinine, intended for 
professional use in the measurement of microalbumin creatinine 
and albumin/creatinine ratio in urine.
Recall #Z-1087-9.
CODE
Catalog No. 6011, Lot No. 0988039 EXP March2001.
MANUFACTURER
Bayer Corporation - Business Group Diagnostics, Mishawaka, 
Indiana.
RECALLED BY
Bayer Corporation, Elkhart, Indiana, by telephone on June 16, 
1999, followed by letter.  Firm-initiated recall ongoing.
DISTRIBUTION
California, Colorado, Michigan, Texas, international.
QUANTITY
688 units were distributed.
REASON
The above lot can produce erratic results (high and low) for both 
albumin, Creatinine and the ratio of albumin to Creatinine.
________
PRODUCT
Vitros 250 Chemistry System, used to perform clinical tests on 
serum, urine, and cerebral spinal fluid specimens:
a) Catalog No. 8132086, Vitros 250 Chemistry System;
b) Catalog No. 1758143, Vitros 250AT Chemistry System.
Recall #Z-1090/1091-9.
CODE
All serial numbers.
MANUFACTURER
Ortho Clinical Diagnostics, Rochester, New York.
RECALLED BY
Manufacturer, by letter dated February 24, 1999, and March 26, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 3,886 units were distributed.
REASON
The devices may give negatively biased results for digoxin, 
phenytoin, and C-reactive protein.
________
PRODUCT
Titanium Flexible Humeral Nail
a) Part Nos. 475.042 through 475.050;
b) Part Nos. 75.242 through 475.250.
Recall #Z-1092/1093-9.
CODE
Part #475.042 lots: A4GM309, A4GO991, A4GQ670,A4HS309, A4HV924
Part #475.043 lots: A4GL128, A4GM308, A4GO992, A4GQ671, A4HB052, 
A4HM661, A4HS263, A4HV925
Part #475.044 lots: A4GL129, A4GM307, A4GO993, A4GQ672, A4HB053, 
A4HV921
Part #475.045 lots: A4GL130, A4GM306, A4GO994, A4GQ673, A4GQ846, 
A4HB054, A4HK005, A4HR690, A4HS751
Part #475.046 lots: A4GL131, A4GM305, A4GO995, A4GQ674, A4GQ847, 
A4HB055, A4HV920
Part #475.047 lots: A4GL132, A4GM304, A4GO996, A4GQ849, A4HB056, 
A4HR691, A4HV922
Part #475.048 lots: A4GL133, A4GM303, A4GO997, A4GQ848, A4HF356, 
A4HM662, A4HS244, A4HV927
Part #475.049 lots: A4GL133, A4GM302, A4GO998, A4GQ675, A4GQ676, 
A4HB057, A4HS245, A4HV928
Part #475.050 lots: A4GM301, A4GO999, A4GQ677, A4HB058, A4HS246, 
A4HV929
Part #475.242 lots: A4GM359, A4GN261, A4GP001, A4HB059
Part #475.243 lots: A4GM511, A4GN262, A4GP459, A4HB060, A4HS247
Part #475.244 lots: A4GN104, A4GN263, A4GP460, A4GQ850, A4HB061, 
A4HM663, A4HS248
Part #475.245 lots: A4GM510, A4GN264, A4GP461, A4GQ678, A4HB062
Part #475.246 lots: A4GM512, A4GN265, A4GP462, A4GQ679, A4HB063, 
A4HR692
Part #475.247 lots: A4GM508, A4GN266, A4GP463, A4GQ851, A4HB064
Part #475.248 lots: A4GN513, A4GN267, A4GP464, A4HB065, A4HC149, 
A4HS249
Part #475.249 lots: A4GM514, A4GN268, A4GP465, A4HB066, A4HM665, 
A4HS900
Part #475.250 lots: A4GM509, A4GN269, A4GP466, A4HB067, A4HC148, 
A4HS250.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by telephone on November 19, 
1998.  Firm-initiated recall complete.
DISTRIBUTION
Alabama, California, Maryland, Minnesota, North Carolina, Oregon, 
Washington state, Canada, Switzerland.
QUANTITY
538 units.
REASON
The central wires may be undersized which could cause 
disengagement at the proximal end.

END OF ENFORCEMENT REPORT FOR JULY 28, 1999.

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