FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.

August 26, 1998 98-34

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________ PRODUCT
Rich's Strawberry Shortcake, 3.25 ounce (individual serving size), in a clear plastic container, ready to eat and shipped frozen, 48 units per case. Recall #F-586-8.

CODE
All product that fails to declare eggs and skim milk in the ingredient statement.

MANUFACTURER
Rich Products Corporation, Buffalo, New York.

RECALLED BY
Manufacturer, by fax on July 27, 1998, and by press release on July 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
Approximately 3,000 cases were estimated to remain on the market.

REASON
Product contains undeclared eggs and skim milk.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________ PRODUCT
POWERaDE Mountain Blast Powder, in 2 gallon canisters. Recall #F-582-8.

CODE
8161OL.

MANUFACTURER
The Minute Maid Company for Coca-Cola USA at Olmarc Packaging Company, Northlake, Illinois.

RECALLED BY
Coca Cola USA Operations, Atlanta, Georgia, by E-mail and fax on July 23, 1998, followed by telephone. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, Florida, Georgia, Kansas, Louisiana, Minnesota, Texas.

QUANTITY
1,198 cases were distributed; firm estimated that 100 cases remained on market at time of recall initiation.

REASON
Product contains undeclared FD&C Yellow No. 5.

________
PRODUCT
Colman's English Mustard, in 1 pound, 2 ounce and 4 ounce cans. Recall #F-584-8.

CODE

All product that is currently being held at the retail level
including on-shelf, in back rooms, and in retail warehouses as
well as distribution centers.  The following lot numbers are
currently being held at the firm's distribution centers:
1 LB can:
Lot # 97184, 94273, 97156, 97288, 97289, 97300, 98001, 97196,
97259, 97185, 97155, 97141, 97273, 97072, 97260, 97274, 96325,
96351.
2 oz can:
Lot # 98043, 98050, 97043, 98049, 98001, 98042
4 oz can:
Lot # 97266, 97308, 98001, 97253, 97016, 97021, 97079, 97260,
97305, 97309, 97314, 97329.

MANUFACTURER
Division of Van den Bergh Foods Limited, (Coleman's of Norwich), Crawley, West Sussex, United Kingdom.

RECALLED BY
Reckitt & Colman, Inc., Wayne, New Jersey, by telephone followed by letter on March 31, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Undetermined.

QUANTITY
1,320,000 cans were distributed.

REASON
Product may contain undeclared wheat.

________
PRODUCT
Canned Bartlett Pears: a) Nugget Brand Peeled Diced Bartlett Pears, in light syrup, in 106 ounce cans and b)Lasco Brand Diced Bartlett Pears in Light Syrup, 6 lbs, 9 oz. cans. Recall #F-585-8.

CODE
Nugget Brand cans are ink-jet coded "BPXO S7LDS" plus a four digit military time such as "1701". Cases are coded "122307" (date product was cased). Lasco Brand cans are ink-jet coded "BPXO S7LDS" plus a four digit military code time such as "1701". Cases are coded TB01088 (date product was cased).

MANUFACTURER
Truitt Bros., Inc., Salem, Oregon.

RECALLED BY
Manufacturer, by fax and telephone on July 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Tennessee, Missouri and Arkansas.

QUANTITY
The firm estimates that less than 50 cases (6 cans/case) of the mislabeled product were distributed.

REASON
Product contains undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.

________
PRODUCT
Caffeine Free Diet Coke, in 2 liter PET containers. Recall #F-587-8/F-588-8.

CODE
AUG3198NHC.

MANUFACTURER
Coca-Cola Bottling of New England, Needham Heights, Massachusetts.

RECALLED BY
Manufacturer verbally and by E-mail on July 31, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts and Rhode Island.

QUANTITY
14,557 cases were distributed.

REASON
Undeclared sugar - The product actually contains Caffeine Free Coca-Cola Classic.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________
PRODUCT
Picante Sauce and Salsa, in 64 ounce containers: a) Pace Medium Picante Sauce; b) Pace Mild Picante Sauce; c) Pace Medium Thick & Chunky Salsa; d) Pace Mild Thick & Chunky Salsa. Recall #F-578/581-8.

CODE

a) Last 5 digits: 00058 and 60658
b) Last 5 digits: 00057 and 60657
c) Last 5 digits: 14164 and 60641
d) Last 5 digits: 14064.

MANUFACTURER
Campbell Soup Company, Sacramento, California.

RECALLED BY
Campbell Soup Company, Camden, New Jersey, by letter dated July 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Japan.

QUANTITY
90,199 cases (6 units per case) were distributed.

REASON
Products are unfit for food due to spoilage caused by lactic organisms.

________
PRODUCT
Tony's French Bread Cheese/Cheese Substitute Pizza. Recall #F-583-8.

CODE
010698.

MANUFACTURER
Better Baked Foods, North East, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on January 13, 1998, followed by letter. Firm-initiated recall complete.

DISTRIBUTION
Missouri and Ohio.

QUANTITY
2523 cases were distributed.

REASON
Product was found to have small pieces of metal in the crust.

________
PRODUCT
Caffeine Free Coca-Cola Classic, in 2 liter PET containers. Recall #F-588-8.

CODE
AUG3198NHC.

MANUFACTURER
Coca-Cola Bottling of New England, Needham Heights, Massachusetts.

RECALLED BY
Manufacturer verbally, and by E-mail on July 31, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts and Rhode Island.

QUANTITY
9,531 cases were distributed.

REASON
Undeclared aspartame - The product actually contains Caffeine Free Diet Coke.

________
PRODUCT
Open Pit Thick & Tangy Barbecue Sauce, Smokehouse Grill Variety, in 18 ounce glass jars. Recall #F-589-8.

CODE
FEB99 02137, APR99 04037, MAY99 05087, JUN99 06067, and MAR00 03188. The Jar codes are followed by the code "CU RZZ4", and a four digit hour code. The product is also identified with the Case codes: 13FEB99, 03APR99, 08MAY99, 06JUN99, and 18MAR00. UPC Code: 54100 10519.

MANUFACTURER
Campbell Soup Company, Napoleon, Ohio (responsible firm).

RECALLED BY
Vlasic Foods, International, Cherry Hill, New Jersey, by E-mail and fax on July 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Illinois, Michigan, Ohio, Pennsylvania, Wisconsin, Colorado, North Carolina.

QUANTITY
53,470 cases (12 jars per case) were distributed.

REASON
The nutrition facts panel on the product incorrectly lists sugars as 0g per serving when the product actually contains 11g sugar per serving.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
Oxygen, USP, in high pressure aluminum cylinders, used for respiratory therapy and emergency oxygen. Recall #D-223-8.

CODE
All lots.

MANUFACTURER
Cambria Medical Company (formerly Altoona Medox Ent, Inc.), Altoona, Pennsylvania.

RECALLED BY
Manufacturer, by visit to be accomplished by the end of May 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Pennsylvania.

QUANTITY
Undetermined.

REASON
Good manufacturing practice deviations.

________
PRODUCT
Nitrostat Sublingual Tablets (Nitroglycerin), 0.4 mg (1/150 gr) in bottles of 25, indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Recall #D-225-8.

CODE
Lot numbers: 11906F EXP 10/98, 01417F EXP 12/98.

MANUFACTURER
Warner Lambert Company, Fajardo, Puerto Rico.

RECALLED BY
Parke-Davis, Division of Warner Lambert Company, Morris Plain, New Jersey, by letter on June 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
25,657 bottles of lot 11906F and 24,353 bottles of lot 01417F were distributed.

REASON
Subpotent at 15 and 18 month stability test stations.

________
UPDATE Recall #D-100/103-8, Propranolol HCL (Inwood Laboratories), which appeared in the March 25, 1998, April 1 and 15, 1998, and July 29, 1998 Enforcement Reports has been extended as follows: Propranolol HCL, 60 mg, Extended Release (ER) Capsules, 100 count bottles, 1 additional lot 7J032.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
Casanthranol and Docusate Sodium Capsules, 30/100 mg, in 60 and 100 capsule bottles, OTC laxative and stool softener, under the Good Neighbor Pharmacy and Brite-Life labels. Recall #D-224-8. CODE
Good Neighbor 60s, NDC 24385-495-72, BBC # 792-242, Lots: F032 (exp. date 2/2000), F047 (2/2000), F055 (3/2000), F088 (5/2000), F107 (4/2000), F138A (6/2000). Good Neighbor 100s, NDC 24385-495-78, BBC # 897-074, Lots: E288 (12/1999), F088A (5/2000). Brite Life 60s, NDC 24385-495-72, BBC # 791-988, Lots: F032 (2/2000), F047 (2/2000), F066 (3/2000), F107 (4/2000), F138 (6/2000). Brite Life 100s, NDC 24385-495-78, BBC # 897-363, Lots: E289 (12/1999), F088A (5/2000).

MANUFACTURER
RP Scherer North America, St. Petersburg, Florida.

RECALLED BY
PL Developments, Inc., Farmingdale, New York, by telephone on July 22, 1998, followed by letter on July 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Michigan and California.

QUANTITY
50,277 bottles of all lots and sizes were distributed.

REASON
Immediate container label lacks directions for use/dosage instructions.

________
PRODUCT
OTC Calcium Supplements, 1.8 gm, in 16 fluid ounce (pint) bottles: a) Calciquid, Calcium Supplement (Calcium Glubionate Syrup, USP, Econolab brand NDC 55053-690-16; Breckenridge brand NDC #51991-495-16; b) Calcionate, Calcium Supplement (Calcium Glubionate Syrup, USP), Rugby brand, NDC # 0536-2770-85. Recall #D-226/227-8.

CODE
Only Lot Number "80416" Expiration of "3-01".

MANUFACTURER
Pegasus Laboratories, Inc., Pensacola, Florida.

RECALLED BY
Manufacturer, by letter on June 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Texas, Arizona, Illinois, Maryland, New York, New Jersey, California, Pennsylvania, Missouri, Kentucky, Indiana, Georgia, Iowa.

QUANTITY
2,360 pints were distributed.

REASON
Mislabeling - Some of the bottles contain a different product-Crantex Liquid (phenylpropanolamine HCL 20 mg/guaifenesin 100 mg/alcohol 5% in each 5 ml).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Platelets. Recall #B-1424-8.

CODE
Unit numbers: 1468015 and 1461973.

MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.

RECALLED BY
Manufacturer, by letter dated July 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky.

REASON
Blood products were collected from donors who had taken aspirin or aspirin like medications within 72 hours of donation.

________
PRODUCT
Red Blood Cells. Recall #B-1432-8.

CODE
Unit numbers: 10525-5040 and 10577-4502.

MANUFACTURER
Blood Systems, Inc., doing business as United Blood Systems, Scottsdale, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on July 20, 1998, and by letter dated July 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
2 units were distributed.

REASON
Blood products were collected from a donor who traveled to a malarial endemic area.

________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF; c) Plasma. Recall #B-1442/1444-8.

CODE
Unit #L46257.

MANUFACTURER
Northern Illinois Blood Bank, Rockford, Illinois.

RECALLED BY
Manufacturer, by letter dated May 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor taking the drug, Methotrexate.

________
PRODUCT
Ortho Summit Sample Handling System (Hamilton Microlab AT). Recall #B-1449-8.

CODE
Product code 936400.

MANUFACTURER
Hamilton Corp., Bonaduz, Switzerland.

RECALLED BY
Ortho Diagnostic Systems, Inc., Raritan, New Jersey, by letter dated June 27, 1995. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
224 units were distributed.

REASON
Computer software defect could result in the Summit Sample Handling System not being able to confirm instances of improper reagent aspiration or aspiration failure, when used for ELISA testing.

________
PRODUCT
Platelets, Pheresis, Leukocytes Removed by Filtration Irradiated. Recall #B-1450-8.

CODE
Unit #3020070.

MANUFACTURER
The Blood Center, New Orleans, Louisiana.

RECALLED BY
Manufacturer, by telephone on January 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
Red Blood Cells. Recall #B-1453-8.

CODE
Unit #8802394.

MANUFACTURER
The Blood Center, New Orleans, Louisiana.

RECALLED BY
Manufacturer, by telephone on February 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that compromises the sterility of the unit.

________
PRODUCT
Red Blood Cells. Recall #B-1455-8.

CODE
Unit #13T79491.

MANUFACTURER
American Red Cross, Detroit, Michigan.

RECALLED BY
Manufacturer, by telephone on February 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Autologous red blood cells were prepared from a unit of whole blood designated as an overbleed.

________
PRODUCT
Red Blood Cells. Recall #B-1456-8.

CODE
Unit #13GJ20583.

MANUFACTURER
American Red Cross, Detroit, Michigan.

RECALLED BY
Manufacturer, by telephone on March 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
1 unit was distributed.

REASON
Red blood cells were returned because of fibrin clots, were not properly quarantined, and were erroneously distributed.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1460/1461-8.

CODE
Unit #03KN00084.

MANUFACTURER
American Red Cross - Southern Region, Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter dated January 5, 1996. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit was distributed.

REASON
Blood products were collected from a donor who traveled to a malarial endemic area.

________
PRODUCT
Red Blood Cells. Recall #B-1462-8.

CODE
Unit #Q63045.

MANUFACTURER
Carolina-Georgia Blood Center, Greenville, South Carolina.

RECALLED BY
Manufacturer, by letter dated February 21, 1996. Firm-initiated recall complete.

DISTRIBUTION
South Carolina.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who traveled to a malarial endemic area.

________
PRODUCT
Source Plasma. Recall #B-1468-8.

CODE
Unit numbers: WS010047, WS010158, WS010367, WS010386, WS010617, WS010705, WS010906, WS010987, WS01113.

MANUFACTURER
Sera-Tec Biologicals Limited Partnership, Plasmapheresis Center, Winston-Salem, North Carolina.

RECALLED BY
Sera-Tec Biologicals Limited Partnership, Regulatory Office, Harrisburg, Pennsylvania, by letter dated September 19, 1996. Firm-initiated recall complete.

DISTRIBUTION
Germany.

QUANTITY
9 units were distributed.

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.

________
PRODUCT
Plateletpheresis. Recall #B-1469-8.

CODE
Unit #03LL07129.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by telephone on January 2, 1996, and by letter dated January 4, 1996. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit of each component was distributed.

REASON
Blood product was collected in a manner that compromises the sterility of the product.

________
PRODUCT
Platelets. Recall #B-1470-8.

CODE
Unit #3326636.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by fax on February 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was not quarantined after receiving information concerning a post donation illness.

________
PRODUCT
Ortho Summit Sample Handling System (Hamilton Microlab AT). Recall #B-1471-8.

CODE
Product code 936400.

MANUFACTURER
Hamilton Company, Bonaduz, Switzerland (contract manufacturer).

RECALLED BY
Ortho Diagnostic Systems, Inc., Raritan, New Jersey (responsible firm), by letter dated November 2, 1994. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
205 units.

REASON
Computer software defect could result in the Summit Sample Handling System not being able to confirm instances of insufficient reagent aspiration or aspiration failure, when reagent aspiration and primary barcode scanning occur simultaneously during ELISA testing.

________
PRODUCT
Recovered Plasma. Recall #B-1472-8.

CODE
Unit #4781249.

MANUFACTURER
Carter BloodCare, Dallas, Texas.

RECALLED BY
Manufacturer, by letter dated May 23, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but was collected from a donor who was previously deferred for testing initially reactive for anti-HIV-1, followed by a single negative retest.

________
PRODUCT
Red Blood Cells. Recall #B-1474-8.

CODE
Unit #12GH74768.

MANUFACTURER
American Red Cross Blood Services, Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter dated May 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
North Carolina.

QUANTITY
1 unit was distributed.

REASON
Blood product was mislabeled for the Rh(D) antigen.

________
PRODUCT
Platelets. Recall #B-1475-8.

CODE
Unit #03GR14535.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by letter dated February 6, 1996. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit.

REASON
Blood product tested positive for anti-Kell was labeled as negative for unexpected antibodies and distributed for transfusion.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
a) Albumin (Human) "Albutein", 5% and 25% Solutions; b) Plasma Protein Fraction (Human) "Plasmatein", 5% Solution. Recall #B-1445/1446-8.

CODE
a) NB7010AB, NB7012A, NG7816A, NG7823A, NS7001A, NF7012A, NF7013A, and NF7022A; b) PF7005A and PF7006A.

MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, California.

RECALLED BY
Manufacturer, by letters on May 8 and 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide, Hong Kong, Saudi Arabia, Singapore.

QUANTITY
57,202 units were distributed.

REASON
Blood products were packaged with administration sets with a shorter expiration date than the accompanying products.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-1447/1448-8.

CODE
Unit numbers: a) 8783678, 8783680, 8783681; b) 8783673, 8783679, 8783680, 8783681.

MANUFACTURER
The Blood Center, New Orleans, Louisiana.

RECALLED BY
Manufacturer, by telephone on December 11, 1997. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
a) 3 units; b) 4 units were distributed.

REASON
Blood products were labeled with extended expiration dates.

________
PRODUCT
Red Blood Cells. Recall #B-1451-8.

CODE
Unit #8792416.

MANUFACTURER
The Blood Center, New Orleans, Louisiana.

RECALLED BY
Manufacturer, by telephone on March 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
Red Blood Cells. Recall #B-1452-8.

CODE
Unit numbers 8777665 through 8777687 inclusive.

MANUFACTURER
The Blood Center, New Orleans, Louisiana.

RECALLED BY
Manufacturer, by telephone on April 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana.

QUANTITY
23 units were distributed.

REASON
Blood products were labeled with extended expiration dates.

________
PRODUCT
Platelets. Recall #B-1473-8.

CODE
Unit #W05597.

MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.

RECALLED BY
Manufacturer, by letter dated June 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with an elevated body temperature.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
Hewlett Packard Image Point Ultrasound System, Model 2410A used with the Model M21359A 7.5 MHZ Linear Transducer, used in ultrasound imaging to determine stenosis of the carotid artery. Recall #Z-160-8.

CODE
All systems with Software Rev. A.0.0., A.0.1, A.0.2.

MANUFACTURER
Hewlett Packard Company, Medical Products Group, Andover, Massachusetts.

RECALLED BY
Manufacturer, by letter dated July 20, 1997. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
441 units were distributed.

REASON
software overestimates peak blood velocity by 15-25% in some Doppler examinations with the Model 2135A transducer.

________
PRODUCT
I-125 Rapid Strand, Rigid Absorbable Permanent Implant Device, I-125 Seeds for Brachytherapy, indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment, such as prostate cancer or unresectable tumors, or for treatment of residual disease after excision of the primary tumor. Recall #Z-776-8.

CODE
Catalog #7000, Lot P8076C.

MANUFACTURER
Nycomed Amersham Imaging, doing business as Medi-Physics, Inc., Arlington Heights, Illinois.

RECALLED BY
Manufacturer, by telephone on July 29, 1998. Firm-initiated recall complete.

DISTRIBUTION
Wisconsin.

QUANTITY
10 strands were distributed.

REASON
The seeds were labeled with an activity of 3700 mCi but actually had an activity of 3400 mCi.

________
PRODUCT
Board Assembly, PCB ASSY #1 + 2, Part No. 71-04-01-142S, utilized with the Flo-Gard 8200 Volumetric Infusion Pump, product code 2M8023, an electronic component for the Flo-Gard 8200 Volumetric Infusion Pump, composed of two printed circuit boards connected by ribbon cables. This board assembly contains the operational software for the infusion pump. Recall #Z-777-8.

CODE
There are no lot numbers. Units affected were shipped between 2/20/98 and 6/15/98 for self service repairs.

MANUFACTURER
Nera Electronics Pte. Ltd., Singapore.

RECALLED BY
Baxter Healthcare Corporation, IV Systems Division, Round Lake, Illinois, by telephone on July 27-31, 1998, followed by letter on August 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, North Carolina, New Jersey, Illinois, Texas, Pennsylvania, South Carolina, Georgia and Puerto Rico.

QUANTITY
13 board assemblies were distributed.

REASON
The board assemblies had the wrong software version installed on them. The boards have version 2.09 instead of version 2.13.

________
PRODUCT
"DRS SYSTEM", a spinal traction device used to provide patient static traction, intermittent traction as well as numerous other claimed intended uses such as: Low back pain relief, degenerated disc, facet disease, herniated disc, sciatica, joint mobilization, myofascial release and ligamentous stretch, etc. NOTE: The device itself is NOT UNDER RECALL, rather the instruction manual and certain promotional material containing unapproved therapeutic claims is under recall. Recall #Z-782-8.

CODE
All units.

MANUFACTURER
Professional Distribution Systems, Inc.,(PDS), Boca Raton, FL.

RECALLED BY
Manufacturer, by fax and letter mailed on June 25, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Indiana, South Carolina, Illinois, Utah, New Jersey, Florida, Missouri, North Carolina, Georgia, Pennsylvania, Connecticut, Alabama, District of Columbia, California, Tennessee, Maryland, Nicaragua, Canada.

QUANTITY
33 units were distributed.

REASON
The earlier versions of the devices Operator's Manual and Sales Brochures contain terminology and claims that are unacceptable for the approved 510K now and was originally violative because the firm had not approved 510K when the devices were originally distributed.

________
PRODUCT
300MS Portable Mobile Stand, for use with MinXray's H500 Portable X-Ray Unit, X903G Portable Veterinary X-Ray Unit, and HF80 and HF100 High Frequency Portable Veterinary X-Ray Units. A stand used with portable x-ray units to allow positioning of the x-ray head over the center of a hospital bed. The stand has casters to allow mobility, a tube arm that raises and lowers via hand crank and the head swivels both left and right, easily disassembling for transport. Recall #Z-784-8.

CODE
Stands distributed between 11/2/92 and 3/25/93.

MANUFACTURER
Kaufman Products Chicago, Illinois.

RECALLED BY
MinXray Inc., Northbrook, Illinois, by telephone on March 30, 1998 through April 2, 1993, and by letters dated April 6 and 12, 1993, followed by letter and telephone on June 21, 1995. Firm-initiated field correction complete.

DISTRIBUTION
Kentucky, Florida, Ohio, Illinois, Texas, Oklahoma, Utah and Minnesota, for further distribution to end user locations.

QUANTITY
22 stands were distributed.

REASON
The lock nut on the handle holding assembly could come loose, allowing the x-ray head to fall on the patient.

________
PRODUCT
CoaguChek PT Test Strip, sold for professional use in conjunction with the CoaguChek System, for quantitative prothrombin time testing in fresh capillary or venous whole blood. Recall #Z-785-8.

CODE
Lot 090 EXP 12/31/99.

MANUFACTURER
Roche Diagnostics/Boehringer Mannheim Corporation, Indianapolis, Indiana.

RECALLED BY
Manufacturer, by letter sent on June 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
1,607 test kits were distributed between June 8 and June 24, 1998.

REASON
The firm's quality assurance testing found that some of the packages have an incomplete seal in the foil wrap and that could lead to strip degradation and potentially erroneous test results.

________
PRODUCT
Software Versions 3.22 and 3.23, Catalog #81500, a medical device used for in-vitro quantitative determinations of various clinical chemistries in serum. Recall #Z-786/787-8.

CODE
All analyzers with software versions 3.22 and 3.23 Catalog #81500.

MANUFACTURER
Beckman Coulter, Inc., Brea, California.

RECALLED BY
Manufacturer, by letter on June 24, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 1,296 units were distributed.

REASON
Software anomaly in these versions may allow test results to be posted to a different patient sample number.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

________
PRODUCT
Radix Labs Milk Fever C Sterile-nonpyrogenic, for the treatment of milk fever or hypocalcemia in cattle, sheep, swine and horses, 500 ml per bottle. Recall #V-027-8.

CODE
Lot #R7A006 EXP 1/99.

MANUFACTURER
Radix Laboratories, Inc., Eau Claire, Wisconsin.

RECALLED BY
Manufacturer, by letter dated July 31, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Wisconsin.

QUANTITY
1,655 500-ml bottles were distributed.

REASON
Precipitate found in the injectable product at 18 month check (product has 2 year expiration dating).

END OF ENFORCEMENT REPORT FOR AUGUST 26, 1998.