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.
July 1, 1998
98-26

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

PRODUCT
Barcelona Fruit & Nut Mix, in 7 ounce packages. Recall #F-513-8.

CODE
All lots of the 7 ounce packages.

MANUFACTURER
Barcelona Nut Company, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated May 29, 1998. Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. See also FDA press release P98-16, May 29, 1998.

DISTRIBUTION
New York and Maryland.

QUANTITY
202 cases (12 units per case) were distributed.

REASON
The product contains undeclared sulfites.

________

PRODUCT
Dried fruit products: a) Preserved Prune (Dried) in hard plastic container, Net Wt. 3.85 oz. (110g), packed 48 boxes per carton; b) Pine Mark brand Dried Fructus Mums (Dried Plums) in plastic box, Net Wt. 10 oz, packed 50 boxes per carton; c) Golden Lion brand Dried Plum (Dried Fructus Mums) in flexible plastic (cellophane) bags, Net Wt. 5 oz.(141.8g), packed 100 bags per carton; d) Pine Mark brand Dried Plum in plastic box, Net Wt. 9 oz., packed 50 boxes per carton. Recall #F-514/517-8.

CODE
None.

MANUFACTURER
Taishan Foodstuff Imports & Export Company, Taishan City, Guandong, China (packer).

RECALLED BY
Blooming Import, Inc., Brooklyn, New York (importer), by letter on March 4 and 11, 1998. Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
Undetermined.

REASON
The products contain undeclared or unapproved food additives and color additives as listed below:

a) unapproved color additive, FD&C Yellow No. 5, sodium saccharin, and sulfites b) unapproved color additive, sodium saccharin, and sulfites c) unapproved color additive, sodium saccharin, and sulfites d) FD&C Yellow No. 6, sodium saccharin, and sulfites.

________

PRODUCT
a) Bahama brand Conch Fritters, patties, packed in cardboard cartons of 18 patties (net wt. 4.10 lbs.) or 4 patties (net wt. 0.9 lbs.); b) Bahama brand Conch Fritters, bites, packaged in cardboard cartons of 98 bites (net wt. 2.60 lbs.) or 36 bites (net wt. 0.95 lbs.). Recall #F-526/527-8.

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

MANUFACTURER
Bahama Seafood, Inc., Miami, Florida.

RECALLED BY
MANUFACTURER
, by telephone and fax on May 29, 1998, and by press release. Firm-initiated recall ongoing.

DISTRIBUTION
Florida.

QUANTITY
Approximately 200 cases were distributed.

REASON
Product contains undeclared eggs and dry milk.

________

PRODUCT
Jarrita Chonita Tejocote Candy, in 11.42 ounce retail packages. Each retail package contains a mixture of white, green, light brown, or light purple ceramic jars that in turn contain the candy product. Recall #F-529-8.

CODE
: None.

MANUFACTURER
Productos Chonitas, Mexico

RECALLED BY
Marquez Brothers Foods, Inc., San Jose, California, by press release on May 21, 1998, and by ------ beginning April 6, 1998, followed by visit. Firm-initiated recall ongoing.

DISTRIBUTION
California.

QUANTITY
46 cases were distributed.

REASON
Product is contaminated with lead.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

PRODUCT
Dried Fruit Products: a) Golden Lion brand Dried Plum in flexible plastic bag, Net Wt. 3.5 oz. (100g), packed 50 bags per carton; b) Preserved Prune (Dried Plum) in hard plastic container, Net Wt. 2.275 oz. (65g), packed 48 boxes per carton; c) Golden Lion brand Preserved Prune in flexible plastic (cellophane) bags, Net Wt. 2.5 oz. (70g), packed 50 bags per carton; d) Preserved Tangerine in hard plastic container, Net Wt. 4.37 oz. (125g), packed 48 boxes per carton; e) Golden Lion brand Dried Carambola in flexible plastic (cellophane) bag, Net Wt. 3.5 oz. (100g), packed 50 bags per carton; f) Pine Mark brand Dried Plum in plastic box, Net Wt. 5.5 oz, packed 50 boxes per carton; g) Golden Lion brand Preserved Figs in flexible plastic (cellophane) bag, Net Wt. 3 oz. (85g), packed 50 bags per carton; h) Golden Lion brand Preserved Ginger in flexible plastic (cellophane) bag, Net Wt. 3.5 oz. (100g), packed 50 bags per carton. Recall #F-518/525-8.

CODE
None.

MANUFACTURER
Taishan Foodstuff Imports & Export Company, China (packer).

RECALLED BY
Blooming Import, Inc., Brooklyn, New York (importer), by letters March 4 and 11, 1998. Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

QUANTITY
Undetermined.

REASON
The products contain undeclared or unapproved food additives and color additives as listed below: a) unapproved color additive, sodium saccharin (in addition, the ingredient statement for this products lists tangerines as an ingredient instead of plums) b) unapproved color additive, FD&C Yellow No. 5, sodium saccharin c) unapproved color additive, FD&C Yellow No. 6, sodium saccharin d) FD&C Yellow No. 6, sodium saccharin, sulfites e) unapproved color additive, FD&C Yellow No. 6, sodium saccharin, sodium benzoate; f, g, h) sodium saccharin.

________

UPDATE
Dried fruit products which appeared in the June 24, 1998 Enforcement Report should read: Recall #F-509/511-8. In the "manufacturers" portion, Summit Import Corporation, New York, New York is the repacker.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

PRODUCT
Platelets. Recall #B-843-8.

CODE
Unit numbers: 22LN66660, 22LN66661, 22LN66662, 22LN66663, 22LN66664, 22LN66665.

MANUFACTURER
American Red Cross - Penn Jersey Region, Philadelphia, Pennsylvania.

RECALLED BY
Manufacturer, by letter dated January 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania.

QUANTITY
6 units were distributed.

REASON
Blood products, which were exposed to unacceptable shipping temperatures and not relabeled appropriately.

________

PRODUCT
a) Red Blood Cells; b) Platelets, for further manufacture; c) Recovered Plasma. Recall #B-1089/1091-8.

CODE
Unit numbers: a) 18Y93574, 18E80855, 18Y73542; b) 18FK05308; c) 18Y93574, 18E80855, 18FK05308, 18Y73542.

MANUFACTURER
American Red Cross Blood Services, Lansing, Michigan.

RECALLED BY
Manufacturer, by letter dated January 28 or 29, 1998, or February 6 or 11, 1998, and February 18, 1998 or March 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan and California.

QUANTITY
a) 3 units; b) 1 unit; c) 4 units were distributed.

REASON
Blood products, collected from a donor whose spouse was receiving clotting factor concentrates.

________

PRODUCT
a) Whole Blood; b) Red Blood Cells; c) Fresh Frozen Plasma; d) Plasma, Frozen within 24 Hours after Phlebotomy; e) Red Blood Cells for Further Manufacture; f) Recovered Plasma, Frozen. Recall #B-1249/1254-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letters dated September 1, 1997, October 1, 1997, December 31, 1997, or May 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arkansas, Florida, Illinois, Missouri, Michigan, Tennessee, California.

QUANTITY
a) 1 unit; b) 33 units; c) 3 units; d) 1 unit; e) 5 units; f) 32 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, and was subjected to additional retesting.

________

PRODUCT
Red Blood Cells. Recall #B-1259-8.

CODE
Unit #38E66896.

MANUFACTURER
American Red Cross Blood Services, Fort Wayne, Indiana.

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

DISTRIBUTION
Indiana.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who had dental surgery on the day of donation.

________

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1260/1261-8.

CODE
Unit #15034-3041.

MANUFACTURER
United Blood Services, McAllen, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated March 3 and 16, 1998, and April 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and North Carolina.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who was currently deferred for receiving a tattoo.

________

PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-1262/1263-8.

CODE
Unit #11317-0414.

MANUFACTURER
United Blood Services, El Paso, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated December 16, 1997, and March 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had surgery within five months of donation.

_______

PRODUCT
a) Red Blood Cells; b) Platelets, Pheresis; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-1264/1267-8.

CODE
Unit numbers: a) 0484612, 0487300, 0491526; b) 5037141, 5037142, 5037421, 5037422, 5037831, 5037832, 5038472, 5039821, 5039822, 5040382, 5042641, 5042642, 5042811, 5043251, 5043252, 5044081, 5044082, 5046801, 5046802, 5048321, 5048322, 5048952, 5053141, 5053142, 5054771, 5054772, 5056741, 5056742; c) 0484612; d) 0487300, 5038471, 5038821, 5038822, 5040381.

MANUFACTURER
Coffee Memorial Blood Center, Amarillo, Texas.

RECALLED BY
Manufacturer, by letter dated March 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas, Arkansas, Tennessee, Colorado, California.

QUANTITY
a) 3 units; b) 28 units; c) 1 unit; d) 5 units were distributed.

REASON
Blood products were collected from a donor who previously tested CMV positive.

________

PRODUCT
Platelets, Pheresis. Recall #B-1268-8.

CODE
Unit #28GP09156.

MANUFACTURER
American Red Cross Blood Services, Savannah, Georgia.

RECALLED BY
Manufacturer, by telephone on January 12, 1998, and by letter dated January 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
1 unit was distributed.

REASON
Blood product had a high platelet count.

________

PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma, Frozen. Recall #B-1269/1271-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letters dated September 1, 1997, October 1, 1997, November 6, 1997, January 8, 1998, and March 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida, Illinois, Iowa, California.

QUANTITY
a) 28 units; b) 5 units; c) 23 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, and was subjected to additional retesting.

________

PRODUCT
Source Leukocytes, for further manufacturing. Recall #B-1272-8.

CODE
Unit #16LG05665.

MANUFACTURER
American Red Cross, Columbus, Ohio.

RECALLED BY
Manufacturer, by telephone on April 3, 1998, and by letter dated April 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
1 unit was distributed.

REASON
Blood product was not quarantined and released despite the donor's use of a positive confidential unit exclusion (CUE) sticker.

________

PRODUCT
Red Blood Cells, Leukocyte Reduced. Recall #B-1278-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
Northern Illinois Blood Bank, Rockford, Illinois.

RECALLED BY
Manufacturer, by telephone on January 12, 1998, and by letters dated April 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
419 units were distributed.

REASON
Blood products were leukoreduced using filters associated with post transfusion conjunctivitis.

________

PRODUCT
Cryoprecipitated AHF. Recall #B-1279-8.

CODE
Unit #03FV47701.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by telephone on November 21, 1997, followed by letter dated November 26, 1997. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood with an extended collection time, was distributed. The corresponding unit of red blood cells was returned due to clots.

________

PRODUCT
Cryoprecipitated AHF. Recall B-1280-8.

CODE
Unit #03FV47681.

MANUFACTURER
American Red Cross Blood Services, Atlanta, Georgia.

RECALLED BY
Manufacturer, by telephone on December 2, 1997, followed by letter dated December 3, 1997. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood with an extended collection time, was distributed. The corresponding unit of red blood cells was returned due to clots.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________

PRODUCT
Reagent Red Blood Cells, Referencells for ABO Serum Grouping Kits. Recall #B-1104-8.

CODE
Lot 37113.

MANUFACTURER
Immucor, Inc., Norcross, Georgia.

RECALLED BY
Manufacturer, by letter dated September 25, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
3,105 kits were distributed.

REASON
Reagent red blood cells were accompanied by an incorrect direction circular.

________

PRODUCT
Fresh Frozen Plasma. Recall #B-1258-8.

CODE
Unit #11Z64677.

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

RECALLED BY
Manufacturer, by telephone on May 27, 1997. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for unexpected antibodies, but was collected from a donor who tested positive for unexpected antibodies on a previous donation.

________

PRODUCT
a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis; d) Fresh Frozen Plasma; e) Recovered Plasma. Recall #B-1273/1277-8.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, Alaska.

RECALLED BY
Manufacturer, by letter dated May 23, 1994. Firm-initiated recall complete.

DISTRIBUTION
Alaska, California, Florida.

QUANTITY
a) 34 units; b) 23 units; c) 2 units; d) 1 unit; e) 33 units were distributed.

REASON
Firm failed to follow manufacturer's product insert for HBSAG testing.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

PRODUCT
SureStep Blood Glucose Monitoring System (Meter), Catalog No. 010-341(retail; meter shipped as part of a system) intended for use outside the body (in-vitro diagnostic), to quantitatively measure glucose (sugar) levels in whole blood taken during home-care use. Recall #Z-631-8.

CODE
Serial Nos. L6000 XX XXXXX through L7205 XX XXXXX. MANUFACTURER
LifeScan, Inc., Milpitas, California.

RECALLED BY
Manufacturer, by press release on June 4, 1997, and by letters sent beginning on June 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
727,004 meters were distributed.

REASON
The meters may give an Er 1 (Error 1) message if a patients blood glucose is 500mg/dL or greater.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

PRODUCT
3M Precise RSH-100 Reusable Skin Stapler Handle, Product numbers: DS-5, DS-15, DS-25, MS-5, MS-15, MS-25, and MS-35, an accessory to 3M Disposable Multi-Shot Skin Staplers. Used to close wounds or incisions in the skin. Recall #Z-602-8.

CODE
Lot numbers APR97-001, APR97-002, and DEC97-001.

MANUFACTURER
Thermotech, Hopkins, Minnesota.

RECALLED BY
3M Health Care, 3M Company, St. Paul, Minnesota, by letter on June 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Florida, Georgia, Minnesota, Missouri, Pennsylvania, Texas.

QUANTITY
1,944 handles were distributed.

REASON
A product defect could cause the skin stapler anvil or plastic detent tab to break.

________

PRODUCT
Laparoscopic Insufflation Tube, Model C2001, single patient use for delivering carbon dioxide gas into the abdomen during laparoscopic surgery. Recall #Z-623-8.

CODE
Lot 97J300.

MANUFACTURER
Applied Medical Resources (AMR), Laguna Hills, California.

RECALLED BY
Manufacturer, by telephone on May 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Florida, Hawaii, Illinois, Maryland, Michigan, Missouri, Nebraska, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington state, England.

QUANTITY
200 boxes (10 units per box) were distributed.

REASON
The pouch seals were defective, thereby, compromising the sterility of the device.

________

PRODUCT
In-vitro diagnostic products, used for the quantitative, serial determination of prostate-specific antigen (P.A.) in serum and to aid in the management of patients with prostate cancer using the Ciba Corning ACS: a) ACS:180 P.A., Part #67228100 (50 test kits), Part #672280000 (300 test kits); b) ACS:180 PSA2, Part #570089 (50 test kits), Part #570088 (300 test kits). Recall #Z-625/626-8.

CODE
Lot numbers: a) 5134560 and 5090760; b) 4793413, 5171017, 5187018, 4777113, 4793313, 4823613, 5170917, 5179817, 51186918, and 5191118.

MANUFACTURER
Chiron Diagnostics Corporation, East Walpole, Massachusetts.

RECALLED BY
Manufacturer, by telephone June 18 through 20, 1997, followed by letter. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
a) 180 kits; b) 1,921 kits were distributed.

REASON
The Lite reagent exhibited bottle to bottle variation in relative light units (RLU) due to excessive exposure to light in the warehouse.

________

PRODUCT
ACS:180 Gentamicin, In-vitro diagnostic, used for the quantitative determination of gentamicin in serum or plasma using the Ciba Corning ACS, Part numbers 570021 and 570020. Recall #Z-627-8.

CODE
Lot Numbers: 4913119, 5127619, 5127720, 5199320, 4913019, 4938219, 5066519, 5127820, 5199220.

MANUFACTURER
Chiron Diagnostics Corp., Walpole, Massachusetts.

RECALLED BY
Manufacturer, by telephone on June 30, 1997, and July 1, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
175 kits were distributed.

REASON
The Lite reagent exhibited bottle to bottle variation in relative light units (RLU) due to excessive expose to light in the warehouse.

________

PRODUCT
Natural-Knee II Non-Porous Femoral, Size 1, Right. Recall #Z-635-8.

CODE
Catalog #6307-00-011, Lot #1329609.

MANUFACTURER
Sulzer Orthopedics, Inc., Austin, Texas.

RECALLED BY
Manufacturer, by telephone on April 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Florida, Michigan, Wisconsin.

QUANTITY
5 units were distributed.

REASON
The device packages contained a Natural-knee 1 Porous Femoral, Size 3 Left device instead of the labeled Size 1, Right.

________

PRODUCT
Capture Cytomegalovirus (CMV) Solid Phase System, for the detection of IgG and IgM antibodies to CMV. Recall #Z-648-8.

CODE
Lot Nos. 50170 & 570171 with Capture-CMV indicator cells lot No. 50159, Expiration Date: 01 Jan 97.

MANUFACTURER
Immucor, Inc., Norcross, Georgia.

RECALLED BY
Manufacturer, by letter dated December 13, 1996. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and Italy.

QUANTITY
57 kits were distributed.

REASON
The indicator cells no longer meet their specifications with respect to detection of IgM antibody.

________

PRODUCT
Model Series Dr. Kern "Blue Dream" 32/33 VHO, sunlamp tanning products. Recall #Z-651-8.

CODE
Series 32/33 sunlamp products.

MANUFACTURER
AEGIS International Services, Inc., St. Petersburg, Florida.

RECALLED BY
Manufacturer. FDA approved the firm's corrective action plan on June 15, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
4 units were distributed.

REASON
The sunlamp product failed to comply with 21 CFR 1040.20(c)(2)(ii) and 21 CFR 1040.20(d)(1)(iv) because the products maximum timer interval exceeded the maximum recommended exposure time and the required warning label failed to include an adequate recommended exposure schedule.

________

PRODUCT
14 Various Medical Devices: 1. OmniGuide Guiding Catheter; 2. OmniGuide-FLX Guiding Catheter; 3. JetStream Microcatheter; 4. JetStream II Microcatheter; 5. JetStream-327 Microcatheter; 6. SlipStream Microcatheter; 7. UltraLite Flow-Directed Microcatheter; 8. QuickSilver Guidewire; 9. Grapevine Balloon-Tipped Microcatheter; 10. Solstice Occlusion Balloon System; 11. Stratus Balloon Dikation System; 12. SideFlow Side Hole Infusion Microcatheter; 13. Dilator Accessory; 14. Zeppelin Balloon-Tipped Guiding Catheter. Recall . #Z-652/665-8.

CODE
All codes, all models. Includes all lots of all models of every device ever domestically distributed by MIS.

MANUFACTURER
Medtronic Micro Interventional Systems (MIS), Sunnyvale, California.

RECALLED BY
Manufacturer, by letter on May 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
22,789 units were distributed.

REASON
The premarket notifications were withdrawn by Medtronic, based on the determination that the data supporting the 510(k) were submitted improperly, prior to the acquisition of MIS in 1995.

________

UPDATE
Recall Number Z-048-8, Laser Lancet LB100 Er:YAG Laser Perforator, recalled by TransMedica International, Little Rock, AR, listed in the November 4, 1997 Enforcement Report was canceled/retracted by the FDA based on added information provided by the firm, but was inadvertently unreported in the Enforcement Report sooner. This recall number will be reassigned.

________

UPDATE
Bipolar RX Model Leads, Recall #Z-585-8 which appeared in the June 3, 1998 Enforcement Report should read:

CODE: All RX Model Pacing Leads manufactured since 1983.

MANUFACTURER: Sulzer Oscor, Inc.

QUANITY: 21,000 RX Model Pacing Leads were distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

PRODUCT
Alexon-Trend ProSpecT Cryptosporidium Microplate Assay Kits, Product numbers 540-24 (24 tests) and 540-96 (96 tests), an in vitro diagnostic test kit for the qualitative detection of Cryptosporidium Specific Antigen in aqueous extracts of fecal specimens. RECALL #Z-606-8.

CODE

Product Number      Lot Numbers
540-24              980401, 975011, 970717
540-96              980402, 980808, 975006, 980809, 
                    970883, 970775, 970696.

MANUFACTURER
Alexon-Trend, Inc., Ramsey, Minnesota.

RECALLED BY
Manufacturer, by letter dated March 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
1,196 assay kits were distributed.

REASON
False positive test results for Cryptosporidiosis.

________

PRODUCT
Diagnostic X-ray system components: a) Diagnostic X-ray system component (FST-10 freestanding tube stand); b) Diagnostic X-ray system component (MS-7917 cassette tray upright support structure). Recall #Z-633/634-8.

CODE
FST-10 serial numbers: 98C0272, 98C0277, 98C0273, 98C0240, 98C0276, 98C0268, 98C0246, 98C0257, 98C0248, 98C0262, 98CO245, 98C0253, 98C0230, 98C0267, 98D0353, 98C0247, 98C0263, 98C0235, 98C0236, 98C0234, 98C0242, 98C0252, 98C0237, 98C0260, 98C0258, 98C0250, 98C0243, 98C0269, 98C0264, 98C0266, 98D0343, 98C0270, 98D0345, 98C0238, 98C0254, 98C0271, 98C0259, 98D0350, 98C0241, 98C0251, 98D0346, 98C0274, 98D0340, 98C0261, 98C0344, 98C0249, 98D0352, 98C0275,98C0265. FST-10 serial numbers manufactured for General Electric Medical Systems (GEMS): BST-98C0315, BST-98C0319, BST-98C0323, BST-98CO316, BST-98C0320, BST-98C0328, BST-98CO317, BST-98C0321, BST-98C0406, BST-98C0318, BST-98CO322. MS-7917 serial numbers: 98C0291, 98C0294, 98C0292, 98C0295, 98C0293, 98D0404.

MANUFACTURER
Trex Medical Corporation, Bennett Division, Copiague, New York.

RECALLED BY
Manufacturer, by letter faxed on April 24 and 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANITITY
67 units were distributed.

REASON
The counter weight cables were manufactured with methods that resulted in defective crimps.


SEIZURE ACTIONS:

PRODUCT
Compressed Oxygen, U.S.P. and Medical Oxygen, U.S.P. (98-717-099).

CHARGE
Adulterated -- The methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding do not conform to and are not operated and administered in conformity with current good manufacturing practice regulations.

LOCATION
Evergreen Supply, Inc., Aberdeen, South Dakota.

FILED June 3, 1998 - U.S. District Court for the District of South Dakota, Northern Division; Civil #CIV98-1025, FDC #67233.

SEIZED June 10, 1998. Goods valued at $155,000.

END OF ENFORCEMENT REPORT FOR JULY 1, 1998.

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