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.
June 17, 1998
98-24

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT: Treasure Cave brand Blue Cheese, in 4 ounce squares. Recall #F-505-8.

CODE
7 21 98 1.

MANUFACTURER
Stella Foods, Inc., Fond du Lac, Wisconsin.

RECALLED BY
Beatrice Cheese, Inc., Waukesha, Wisconsin, by letter and press release on April 10, 1998. Completed recall resulted from sample analysis and follow-up by the State of Florida.

DISTRIBUTION
Nationwide.

QUANTITY
123,000 pounds were distributed.

REASON
Product was contaminated with Listeria monocytogenes.

PRODUCT: Taboule Salad, in 7 and 12 ounce containers and in 5 pound bulk containers. Recall #F-506-8.

CODE
9 01.

MANUFACTURER
Basha International, Foods, Inc., Hamtramck, Michigan.

RECALLED BY
Manufacturer, by press release on August 27, 1997. Completed recall resulted from sample analysis and follow-up by the Michigan Department of Agriculture.

DISTRIBUTION
Detroit, Michigan.

QUANTITY
1,000 pounds were distributed.

REASON
Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

PRODUCT: Maple Pumpkin Butter, in 8 ounce glass jar with screw cap.

Recall #F-504-8.

CODE
Lot 0568.

MANUFACTURER
Blanchard & Blanchard, Wilder, Vermont.

RECALLED BY
Manufacturer, on March 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Vermont.

QUANTITY
216 jars were distributed.

REASON
Product is a low-acid canned food that lacked adequate processing. In addition, the manufacturer has not registered with the FDA and has not filed a scheduled process for this product.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

PRODUCT: a) Platelets; b) Recovered Plasma. Recall #B-950/951-8.

CODE
Unit numbers: a) 4577311; b) 4577311, 4778694, 4778711, 4775911.

MANUFACTURER
National Naval Medical Center, Bethesda, Maryland.

RECALLED BY
Manufacturer, by telephone on or about July 7, 1997. Firm-initiated recall complete.

DISTRIBUTION
Maryland, District of Columbia, Pennsylvania, Massachusetts.

QUANTITY
a) 1 unit; b) 4 units were distributed.

REASON
Blood products tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV) by a first generation test, and repeatedly reactive by retrospective second generation testing. PRODUCT: a) Red Blood Cells; b) Cryoprecipitated AHF; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1073/1076-8.

CODE
Unit numbers: a) 55S39062, 55KH05604, 55R76804, 55H28238, 55F57796, 55F61326, 55F64714, 55F67030, 55M11454; b) 55S39062; c) 55H28238, 55F61326; d) 55KH05604, 55R76804, 55F57796, 55F64714, 55F67030, 55M11454.

MANUFACTURER
American Red Cross Blood Services, Little Rock, Arkansas.

RECALLED BY
Manufacturer, by telephone between August 20 and 25, 1997, and by letters dated between August 22 and September 1, 1997. Firm-initiated recall complete.

DISTRIBUTION
Arkansas, Pennsylvania, California, Switzerland.

QUANTITY
a) 9 units; b) 1 unit; c) 2 units; d) 6 units.

REASON
Blood products were collected from a donor having been diagnosed with Sarcoidosis. PRODUCT: a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma d) Cryoprecipitated AHF; e) Platelets, for further manufacture f) Recovered Plasma. Recall #B-1187/1192-8.

CODE
Unit numbers: a) 1196621, 1222637, 1243165, 1263444, 1274363, 1316030, 1356306, 1377525; b) 1222637, 1243165, 1356306 c) 1222637; d) 1274363, 1316030; e) 1222637 f) 1316030, 1377525, 1356306, 1274363, 1263444, 1243165, 1196621.

MANUFACTURER
Central Kentucky Blood Center, Lexington, Kentucky.

RECALLED BY
Manufacturer, by letter dated March 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky, Maryland, California.

QUANTITY
a) 8 units; b) 3 units; c) 1 unit; d) 2 units; e) 1 unit; f) 7 units were distributed. REASON
Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot indeterminate.

PRODUCT: a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma.

Recall #B-1197/1201-8.

CODE
Unit numbers: a) 4543492, 4581530, 4659660, 4765889, 4841614, 4859861, 4910871, 7564271, 9995457; b) 4765889, 4841614, 4910871; c) 4910871, 9995457; d) 4659660, 4859861, 9995457; e) 4543492, 4659660, 4581530, 4765889, 7564271.

MANUFACTURER
Carter BloodCare, Dallas, Texas.

RECALLED BY
Manufacturer, by letter dated January 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas, California, Switzerland.

QUANTITY
a) 9 units; b) 3 units; c) 2 units; d) 3 units; e) 5 units were distributed.

REASON
Blood products tested negative for viral markers, but were collected from donors who previously tested repeatedly reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), the hepatitis B surface antigen (HBsAg), or the antibody to the hepatitis C virus encoded antigen (anti-HCV).

PRODUCT: a) Red Blood Cells; b) Plasma. Recall #B-1207/1208-8.

CODE
Unit #11M71883.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone and letter on July 23, 1997. 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.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

PRODUCT: Recovered Plasma for Manufacturing non-injectable products.

Recall #B-1024-8.

CODE
Unit #11M71893.

MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on September 18, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Failure to quarantine a blood product that tested negative for the Hepatitis B Surface Antigen (HbsAg), which was collected from a donor who subsequently tested repeat reactive for HbsAg.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

PRODUCT: CP-700 X-Ray Generator, a low voltage (120 volt) diagnostic x-ray generator. Recall #Z-565-8.

CODE
Serial numbers: JW0003-0794, JW0004-0794, JW0005-0794, JW0006-0894, JW0007-0894, JW0008-0894, JW0009-0894, JW0011-0994, JW0013-0994, JW0014-0094, JW0015-0994, JW0017-1094, JW0021-1194, JW0022-1194, JW0023-1194, JW0024-1194, JW0025-1194, JW0026-1294, JW0027-1294, JW0028-1294, JW0029-0195, JW0030-0195, JW0032-0295, JW0036-0395, JW0037-0395, JW0038-0395, JW0040-0395, JW0041-0695, JW0042-0695, JW0043-0695, JW0044-0695, JW0045-0795, JW0046-0895, JW0049-0895, JW0050-0995, JW0053-0995, JW0055-0995, JW0056-0995, JW0057-0995, JW0059-0995, JW0060-1095, JW0061-1095, JW0062-1095, JW0063-1095, JW0066-1095, JW0067-1095, JW0068-1195, JW0069-1195, JW0070-1195, JW0072-1195, JW0073-1295, JW0074-1295, JW0075-1295, JW0076-0196, JW0077-0196, JW0078-0196, JW0079-0296, JW0080-0296, JW0082-0296, JW0085-0396, JW0086-0396, JW0087-0396, JW0088-0396, JW0089-0396, JW0090-0496, JW0091-0496, JW0093-0496, JW0094-0496, JW0095-0496, JW0096-0496, JW0098-0496, JW0099-0596, JW0100-0696, JW0101-0796, JW0102-0696, JW0110-0796, JW0111-0896, JW0112-0896, JW0113-0896, JW0115-1096, JW0116-1096, JW0117-1096, JW0118-1196, JW0119-0996, JW0120-1196, JW0121-1296, JW0122-0197, JW0123-0297, JW0124-0397, JW0125-0397, JW0126-0397, JW0127-0497, JW0128-0597, JW0130-0597, JW0131-0597, JW0132-0697, JW0133-0697, JW0134-0697, JW0135-0797, JW0136-0797.

MANUFACTURER
Gendex-Del Medical Imaging Corporation, Franklin Park, Illinois.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan May 18, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
99 units were distributed.

REASON
Units are defective under 21 CFR 1003.2 as a result of the venting of electrolytic capacitors manufactured by General Electric.

PRODUCT: UroView Model 2600 X-Ray Imaging System, general purpose radiography and fluoroscopy. Recall #Z-566-8.

CODE
Model 2600. The problem occurs on tubes beginning with letters V, W, or Y.

MANUFACTURER
OEC Medical Systems, Salt Lake City, Utah.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
16 units were distributed.

REASON
The diagnostic x-ray devices were found defective under 21 CFR 1003.2 in that they do not assure manufacturer's specifications are met because of oil leaks from the tube housing assembly.

PRODUCT: McGaw Stratus Ambulatory Infusion System, Model 550 with Software Version 2.31. Recall #Z-569-8.

CODE
Model 550 w/Software Version 2.31.

MANUFACTURER
Alphamed, Inc., Norcross, Georgia.

RECALLED BY
Manufacturer, by letter and telephone on April 17, 1997. Firm-initiated recall complete.

DISTRIBUTION
Kentucky, Georgia, Texas, New Mexico.

QUANTITY
25 pumps were distributed.

REASON
A software malfunction causes the infusion pump to over-infuse in the circadian mode.

PRODUCT: Clinical Information System (CIS) with Fetal Monitor Remote Display: a) Clinical Information System (CIS) with Fetal Remote Display System (FMRD), Models DAS 422 and DAS 1MS (Data Acquisition System); b) CIS with eight-port DAS, Model DAS-8MC. Recall Z-592/593-8.

CODE
All serial numbers.

MANUFACTURER
Clinicomp International, Inc., San Deigo, California.

RECALLED BY
Manufacturer, by letters on April 6 and 7, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Kansas, Maryland, Minnesota, New York, Ohio, Texas, Virginia, Washington state, Germany, Belgium.

QUANTITY
a) 179 units; 529 units were distributed.

REASON
The Data Acquisition System in conjunction with the Clinical Information System, exhibits open ground test values in excess of stated safety limits.

PRODUCT:: Borrelia Burgdorferi IgG/IgM Elisa Test Kit, for in-vitro diagnostic use. Recall #Z-600-8.

CODE
Kit/Lot No. 446580-005, Expiration Date: 4/1/1998.

MANUFACTURER
Clark Laboratories, Inc., doing business as Trinity Biotech USA, Jamestown, New York.

RECALLED BY
Manufacturer, by letter dated November 3, 1997. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
684 units were distributed.

REASON
The low positive control value is above the labeled range, and may lead to potential delay in diagnosis and treatment.

UPDATE Tri-State Hospital Supply Corporation recall which appeared on the June 3, 1998, Enforcement Report should read: R.S.V. Collection Kit, Nasal Washing Kit, and Wound Care Tray. Recall #Z-588/590-8.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

PRODUCT: ACS:180 CKMB II - Used for quantitative determination of CK-MB in serum using the Chiron Diagnostics ACS:180 Automated Chemiluminescence Systems. The quantitation of the CK-MB (Creatine kinase) levels in serum is used as an aid in the diagnosis of myocardial injury. Recall #Z-546-8.

CODE
Description Part No Kit Lot No. EXP Date 300 Test Kits 104954 5711023 4 June 1998 5751624 4 June 1998.

MANUFACTURER
Chiron Diagnostics Corporation, East Walpole, Massachusetts. RECALLED BY
Manufacturer, by telephone between December 19 and 22, 1997. Firm-initiated recall complete.

DISTRIBUTION
Alabama, California, Florida, Georgia, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, West Virginia, Vermont.

QUANTITY
109 kits were distributed.

REASON
An incorrect revision of the package insert was packaged with the product.

PRODUCT: ACS:180 CKMB II - Used for quantitative determination of CK-MB (Creatine kinase) in serum to aid in the diagnosis of myocardial injury using the Chiron Diagnostics ACS:180 Automated Chemiluminescence Systems. Recall #Z-547/548-8.

CODE

Description      Part#     Kit Lot #      EXP Date
50 Test Kits     104955    4450505        4 March 1997
                           4476705        4 March 1997
                           4484506        15 April 1997
                           5423706        15 April 1997
                           4586007        13 May 1997
                           4667409        6 June 1997
                           4888010        13 Sept 1997
                           5003411        3 Nov 1997
                           5004411        3 Nov 1997
                           5004211        3 Nov 1997
300 Test Kits    104954    4450405        4 March 1997
                           4476605        4 March 1997
                           4476806        15 April 1997
                           4523606        15 April 1997
                           4583007        13 May 1997
                           4643007        13 May 1997
                           4667309        6 June 1997
                           4750809        6 June 1997
                           4887910        13 Sept 1997
                           4919510        13 Sept 1997
                           5003911        3 Nov 1997
                           5004011        3 Nov 1997.

MANUFACTURER
Chiron Diagnostics Corporation, East Walpole, Massachusetts.

RECALLED BY
Manufacturer, by telephone in March 1997 and by "Applications Bulletin" ACS:180 CKMB II Number 15 , date 3/19/97. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
1,236 kits of Part #104955 and 2,458 kits of Part #104954 were distributed.

REASON
Device labeling contains incorrect heparinized plasma test claims.

PRODUCT: MLA Electra Automated Coagulation Testing Instruments: a) Model E900C (Part No. 1095C) b) Model E1000C (Part No. 1096C). Recall #Z-597/598-8.

CODE
Serial numbers: a) 3645 thru 3675; b) 3524-2010, 3523-2011, R001-R001, R004-R004 through R040-R040.

MANUFACTURER
Medical Laboratory Automation, Inc., Pleasantville, New York.

RECALLED BY
Manufacturer, by letter on April 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York, New Jersey, Maryland, Virginia, West Virginia, Tennessee, Florida, Illinois, Michigan, Texas, Oklahoma, Arizona, California.

QUANTITY
a) 31 units; b) 38 units were distributed.

REASON
The video boards are not compatible with the central processing unit.

PRODUCT: Lifeport LPS 5513, consists of a titanium venous access port with an attachable 8.4 French polyurethane catheter and an introducer kit. Recall #Z-594-8.

CODE
Lot #14529 and 14560.

MANUFACTURER
Strato/Infusaid, Inc., Norwood, Massachusetts.

RECALLED BY
Horizon Medical Products, Inc., Manchester, Georgia, by telephone on or about April 29, 1998, followed by letter. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arkansas, California, Florida, Georgia, Illinois, Kentucky, Michigan, Minnesota, Missouri, New York, South Carolina, Tennessee, Texas, Virginia, Washington state, Spain, Germany. QUANTITY
362 units were distributed.

REASON
There is an error in the product description on the shipping and outer tray label.

PRODUCT: Sterile Mayfield Disposable Skull Pins, Catalog #40A1072, used in conjunction with Mayfield brand Skull Clamps when a rigid skeletal fixation is needed to hold the skull in place during brain surgery. Recall #Z-604-8.

CODE
Lot Nos. 0597 EXP 5/99, 0797 EXP 5/99, 0897 EXP 6/99, 0997 EXP 7/99.

MANUFACTURER
Ohio Medical Instruments Company, Inc., Cincinnati, Ohio.

RECALLED BY
Manufacturer, by bulletin dated July 25, 1997, and by letter on April 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
491 cartons (17,676 pins) were distributed.

REASON
A design change to the skull pins resulted in the dimensions of the pin base not being the correct width to fit into all skull clamps. This resulted in the pins being too loose and falling out of the clamps.

MEDICAL DEVICE SAFETY ALERT
PRODUCT: Baxter Fenwal Plasmacell-C Disposable Sets, consisting of the separation device, a reservoir and a tubing set which provides transport for the blood and solutions within a closed blood pathway when used with the Fenwal Autopheresis-C Plasmapheresis System; For collection of Plasma by Membrane Filtration; Manufactured by an affiliate of Baxter Healthcare Corporation, Fenwal Division, Deerfield, IL 60015 USA, Made in Dominican Republic; the following sets are affected by this safety alert: 4R2250, Plasmacell-C Separation Disposable Set with In-line Anticoagulant Drip Chamber, 60 units per case 4R2251, Plasmacell-C Separation Disposable Set with attached 1000 ml Plasma Collection Bag 4R2252, Plasmacell-C Separation Disposable Set, 60 units per case 4R2253, Plasmacell-C Separation Disposable Set - Japanese label 4R2256, Plasmacell-C Separation Disposable Set, for use with SpikeSmart System, 60 units per case 4R2278, Plasmacell-C Separation Disposable Set - French label 4R2283 & 4R2284 - labeling is not available at this time.

These are disposable sets used with the Mini Autopheresis-C in Japan and Korea. The two have different membranes.

Safety Alert #N-007-8.

CODE
All lots.

MANUFACTURER
Baxter S.A. Fenwal Division, Parque Industrial Itabo, Zona France Industrial de Haina, San Cristobal, Republica Dominicana (set).

Baxter Healthcare Corporation, San German, Puerto Rico (separation device sub-assembly manufacturer).

ALERTED BY
Baxter Healthcare Corporation, Biotech Group/Fenwal Division, Deerfield, Illinois, by letter dated October 15, 1997.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 12,000,000 sets are distributed each year.

REASON
The plasma line can detach from the separation device when performing plasmapheresis with the Autopheresis-C instrument END OF ENFORCEMENT REPORT FOR JUNE 17, 1998. BLANK PAGES MAY FOLLOW.

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