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.

December 30, 1998
98-52

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
Frozen Blueberries, in 30 pound cartons and 16 oz. polybags. The 30 lb. Cartons are labeled as "Willamette Farms Fresh Frozen Blueberries" and the repacked 16 oz. Polybags are labeled as "Simplot Blueberries." Recall #F-107-9.

CODE
Cartons are coded 68809148. However, some appear to read 68809143. The repacked 16 oz. polybags are not coded.

MANUFACTURER
Wilt Farms, Coravallis, Oregon.

RECALLED BY
Distributor, Ever Fresh Fruit Company, Boring, Oregon by fax letter dated November 12, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Illinois, and Australia.

QUANTITY
Undetermined.

REASON
Product is contaminated with Listeria monocytogenes.

________
PRODUCT
Gourmet Garage Pesto Ravioli, in 14 ounce plastic containers. Recall #F-108-9.

CODE
10-19, 10-24, 10-26, and 10-30.

MANUFACTURER
New York Ravioli & Pasta Company, Inc., Williston Park, New York.

RECALLED BY
Jan Services, doing business as Gourmet Garage, New York City, New York, by relabeling product beginning October 22, 1998. Completed recall resulted from visits and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
Undetermined.

REASON
Product contains undeclared pine nuts.

________
PRODUCT
Canned pasta products, in 15 ounce cans: a) Mother's Choice Pasta Animals in Sauce b) Mother's Choice Alphabet Pasta in Sauce; c) Mother's Choice Pasta Shells in Sauce. Recall #F-109/111-9.

CODE
All codes on the market at the time of recall.

MANUFACTURER
Rokeach Foods Corporation, Newark, New Jersey.

RECALLED BY
Manufacturer, by letter faxed on October 26 and 27, 1998, followed by telephone and by press release on October 26 and 27 , 1998.

DISTRIBUTION
Nationwide, Canada, Australia.

QUANTITY
a) 3,440 cases (12 cans per case); b) 3,776 cases (12 cans per case); c) 3,696 cases (12 cans per case) were distributed.

REASON
Products contain undeclared egg albumin.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT
Super Blue Green brand BG Bites Raspberry Candy with bilingual label. Recall #F-096-9.

CODE
Lot #8254.

MANUFACTURER
Glenn Foods, Valley Stream, New York.

RECALLED BY
Cell Tech, Klamath Falls, Oregon, by telephone on November 25, 1998. The Canadian Food Inspection Agency issued press release on November 24, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Canada.

QUANTITY
647 boxes (24 pieces per box and 24 boxes per case) were distributed.

REASON
Product contains undeclared almond butter.

________
PRODUCT
Manila Clams in shell harvested from Burley Lagoon in Carr Inlet, Pierce County Washington, by Western Oyster Company, Olympia, Washington, on or after October 19, 1998, in 25 pound bags. Recall #F-097-9.

CODE
Certification #WA58SS. Harvest dates: 10/19/98 and 10/20/98.

MANUFACTURER
Western Oyster Company, Olympia, Washington.

RECALLED BY
Manufacturer, by fax on October 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Hawaii, Washington state.

QUANTITY
1,000 pounds of clams were distributed.

REASON
Product contained PSP levels greater than the 80 mcg per 100 g meat action level specified in CPG 540.250.

________
PRODUCT
Long Life brand Noodle, in 16 ounce plastic bags. Recall #F-098-9.

CODE
None. All product not declaring FD&C Yellow #5 on the label.

MANUFACTURER
Tropico Enterprise Ltd., Bangkok, Thailand.

RECALLED BY
Anhing Corporation, Los Angeles, California, by letter on August 4, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
Arizona, California, Connecticut, Florida, Georgia, Minnesota, Nebraska, North Carolina, Nevada, New York, Oregon, Texas, Utah, Wisconsin.

QUANTITY
92 cases were distributed.

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

________
PRODUCT
Golden Lion Dried Plum, in 120 gram, 10 ounce, and 9 ounce clear flexible bags. Recall #F-105-9.

CODE
None.

MANUFACTURER
Daxin Huafeng Food Company, Ltd., Guangdong, China.

RECALLED BY
Blooming Import, Inc., Brooklyn, New York (importer), by letter via fax and mail on October 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
120 grams size - 39 cases (50 bags per case) 10 ounce size - 78 cases (50 bags per case) 9 ounce size - 40 cases (50 bags per case) were distributed; firm estimates little product remained on market at time of recall initiation.

REASON
Product contains cyclamates and saccharin which are unsafe within the meaning of the food additive provisions.

________
PRODUCT
Raisin bran under the following labels: Ralston Foods Raisin Bran, in 20 ounce boxes; Breakfast Best Raisin Bran, in 18 ounce boxes; Safeway Raisin Bran, in 25.5 ounce boxes. Recall #F-106-9.

CODE
Lot numbers: Ralston label - OCT2099S1; Breakfast Best label - OCT1999S2; Safeway label - OCT1999S2.

MANUFACTURER
Ralston Foods, Sparks, Nevada.

RECALLED BY
Ralston Foods, St. Louis, Missouri, by telephone on November 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Colorado, Ohio.

QUANTITY
120 cases of the Ralston label, 60 cases of the Safeway label and 130 cases of the Breakfast Best label were distributed.

REASON
Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________
PRODUCT
Hy-Vee Pasteurized Fresh Made Apple Cider, in 1 gallon, ´ gallon, 1 quart and 1 pint plastic bottles. Recall #F-099-9.

CODE
All codes on the market at the time of the recall.

MANUFACTURER
Marywood Farms II, Inc., doing business and Marywood Orchard, Indianola, Iowa.

RECALLED BY
Hy-Vee, Inc., West Des Moines, Iowa, by electronic mail message on November 2, 1998 and by press release on November 2, 1998. firm-initiated recall complete.

DISTRIBUTION
Iowa, Illinois, Minnesota, Missouri, Nebraska and South Dakota.

QUANTITY
252- 1 Gallon, 864- ´ gallon, 72- 1 quart and 36- 1 pint containers were distributed.

REASON
Product was contaminated with yeast.

________
PRODUCT
Marywood Orchard Fresh Apple Cider, pasteurized, refrigerated, packaged in 1-gallon, 1/2 gallon and 1 quart plastic bottles. Recall #F-100-9.

CODE
None.

MANUFACTURER
Marywood Farms II, Inc., doing business as Marywood Orchard, Indianola, Iowa.

RECALLED BY
Manufacturer, by telephone on October 31, 1998, and November 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Iowa.

QUANTITY
177 1/2-gallon cases (8 units per case); 390 1-gallon cases (4 units per case); 35 32-ounce cases (16 units per case) were distributed.

REASON
Product was contaminated with yeast.

________
PRODUCT
Green Bean Casserole 2 pounds packaged in MAP (Modified Atmosphere Packaging) as a component of the Complete Dinner Meals: a) Stop & Shop Turkey Dinner, Product #85221 containing: Turkey, Cranberry Sauce, Mashed Potatoes, Holiday Gravy, Butternut Squash, Holiday Stuffing, Green Bean Casserole; b) Stop & Shop Ham Dinner, Product #85261 containing: Spiral Ham, Mashed Potatoes, Butternut Squash and Green Bean Casserole. Recall #F-101-9.

CODE
Product sold through retail Stop & Shop Supermarkets prior to 11/25/98.

MANUFACTURER
Waterbury Fresh Foods, Burlington, Vermont.

RECALLED BY
Stop & Shop Supermarket Company, Boston, Massachusetts, by E-Mail and voice communication on November 25,1998. Firm-initiated recall complete.

DISTRIBUTION
Connecticut, Massachusetts, New York, Rhode Island.

QUANTITY
6,154 dinners were distributed.

REASON
Product was unfit for food due to swollen containers, sour taste and high levels of lactobacillus.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II

________
PRODUCT
Various body lotions: a) Bath Tub Buddies, 2 oz. Baby Lotion with Aloe; b) Medline 2 oz. Hand & Body Lotion; Medline 4 oz. Hand & Body Lotion; and Care 4 oz. Hand & Body Lotion; c) Freshscent 2 oz. Hand & Body Lotion. Recall #F-102/104-9.

CODE
Lot numbers: a) Lots 8279256B, 8279256C; b) Medline 2 oz. Hand &I Body Lotion Lots 8271252A, 8271252B, 8271252C, 8272253A, 8280256C; Medline 4 oz. Hand & Body Lotion, Lots 8269251A, 8269251B, 8269252C, 8278255B, 8278255C, 8279256A, 8279256B; and Care 4 oz. Hand & Body Lotion, Lots 8273253A, 8272253C, 8275254A, 8275254B, 8273254C; c) Lot 8271252A.

MANUFACTURER
Medical Packaging Technologies, Doraville, Georgia.

RECALLED BY
Manufacturer, by letter on October 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Georgia, Illinois, Nevada, New Jersey, New York, North Carolina, Pennsylvania, Tennessee.

QUANTITY
Care - 27 cases (1,620 units); Bath Tub Buddies - 50 cases (4,800 units; Medline 2 oz - 544 cases (52,224 units); Medline 4 oz.-425 cases (25,000 units); Freshscent - 96 cases (9,216 units) were distributed.

REASON
Products are contaminated with Burkholderia cepacia.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______
PRODUCT
Cryoprecipitate. Recall #B-223-9.

CODE
Unit numbers: W77384 and N37241.

MANUFACTURER
Mississippi Blood Services, Inc., Jackson, Mississippi.

RECALLED BY
Manufacturer, by telephone on March 19, 1998. Firm-initiated recall complete.

DISTRIBUTION
Mississippi.

QUANTITY
2 units were distributed.

REASON
Blood products were labeled with extended expiration dates.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-317/319-9.

CODE
Unit #5008256.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated January 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had ear piercing within 12 months of donation.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-327/328-9.

CODE
Unit #T31881.

MANUFACTURER
Southeast Iowa Blood Center, Ottumwa, Iowa.

RECALLED BY
Manufacturer, by telephone and by fax on December 12, 1996. Firm-initiated recall complete.

DISTRIBUTION
Iowa and New Jersey.

QUANTITY
1 unit of each component was distributed.

REASON
Blood product tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc).

________
PRODUCT
Red Blood Cells. Recall #B-329-9.

CODE
Unit #0501638.

MANUFACTURER
LifePulse, LLC, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on June 24, 1998, and by letter dated July 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
Red Blood Cells. Recall #B-330-9.

CODE
Unit numbers: 18215-1266, 18215-1267, 18215-1269.

MANUFACTURER
United Blood Services, Cheyenne, Wyoming.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 22, 1997. Firm-initiated recall complete.

DISTRIBUTION
Wyoming.

QUANTITY
3 units were distributed.

REASON
Blood products were not separated from whole blood within eight hours of collection.

________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Platelets, Irradiated. Recall #B-331/332-9.

CODE
Unit numbers: a) 26156-3190, 26156-3227; b) 26156-3514.

MANUFACTURER
United Blood Service, Fort Smith, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arkansas.

QUANTITY
a) 2 units; b) 1 unit was distributed.

REASON
Blood products were mislabeled as CMV antibody negative.

________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukoreduced; c) Platelets. Recall #B-333/335-9.

CODE
Unit numbers: 20LC19800 and 20LC19997.

MANUFACTURER
American Red Cross, Boise, Idaho.

RECALLED BY
Manufacturer, by letter dated July 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Idaho, Utah.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were mislabeled as CMV antibody negative.

________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-336/337-9.

CODE
Unit numbers: a) 20H06690, 20LM19942; b) 20H06690.

MANUFACTURER
American Red Cross, Boise, Idaho.

RECALLED BY
Manufacturer, by letter dated June 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Idaho.

QUANTITY
a) 2 units; b) 1 unit was distributed.

REASON
Blood products were mislabeled as CMV antibody negative.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-338/340-9.

CODE
Unit numbers: 20LC24058, 20LC24105.

MANUFACTURER
American Red Cross, Boise, Idaho.

RECALLED BY
Manufacturer, by letter dated July 16, 1998, and by telephone on July 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Idaho and Utah.

QUANTITY
a) 2 units of each component were distributed.

REASON
Blood products were mislabeled as CMV antibody.

_______
PRODUCT
Source Plasma. Recall #B-341-9.

CODE
Unit #30 Y9U865.

MANUFACTURER
Centeon Bio-Services, Inc., Lincoln, Nebraska.

RECALLED BY
Manufacturer, by letters dated October 21, 1996, and November 20, 1996. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Germany.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor with a history of Hepatitis.

________
PRODUCT
Platelets, Pheresis. Recall #B-342-9.

CODE
Unit #KK0215.

MANUFACTURER
Gateway Community Blood Program, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone on December 24, 1997, and by letter dated December 30, 1997. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product was drawn from an unsuitable donor.

________
PRODUCT
Platelets, Pheresis. Recall #B-343-9.

CODE
Unit #KG02746.

MANUFACTURER
Gateway Community Blood Program, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone and letter on July 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Missouri.

QUANTITY
1 unit was distributed.

REASON
Blood product was incorrectly labeled with the wrong ABO/Rh type.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-344/345-9.

CODE
Unit numbers: a) 3000306, 3000462, 8008450, 8025134; b) 3000306, 3000462, 8008450.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated November 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio and Florida.

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

REASON
Blood products were collected from a donor who had been deferred from another donor center for having a reactive hepatitis test.

________
PRODUCT
Red Blood Ce0lls. Recall #B-346-9.

CODE
Unit numbers: 10576-5547 and 10580-2825.

MANUFACTURER
United Blood Services, Phoenix, Arizona.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 28 and 31, 1998, and by letter dated April 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
2 units were distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
Platelets, Pheresis. Recall #B-347-9.

CODE
Unit #KZ50072.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letter dated October 6, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall #B-349-9.

CODE
Unit #39P25638.

MANUFACTURER
American Red Cross Blood Services, Roanoke, Virginia.

RECALLED BY
Manufacturer, by letter dated September 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product had an unacceptable platelet count.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-352/353-9.

CODE
Unit numbers: a) 36LQ18099, 36FY14388; b) 36LQ18099.

MANUFACTURER
American Red Cross Blood Services, Columbia, South Carolina.

RECALLED BY
Manufacturer, by letter dated May 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
South Carolina.

QUANTITY
a) 2 units; b) 1 unit was distributed.

REASON
Blood products were collected from a donor who traveled to an area designated as endemic for malaria.

________
PRODUCT
Platelets. Recall #B-354-9.

CODE
Unit #12GW17039.

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

RECALLED BY
Manufacturer, by telephone on September 15, 1998, and by letter dated September 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
North Carolina.

QUANTITY
1 unit was distributed.

REASON
Blood product was mislabeled as CMV antibody negative.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-355/356-9.

CODE
Unit #36R61119.

MANUFACTURER
American Red Cross Blood Services, Columbia, South Carolina.

RECALLED BY
Manufacturer, by letter dated April 27, 1998, and by telephone on April 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
South Carolina and Georgia.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were prepared from an overweight unit of whole blood.

________
PRODUCT
Platelets. Recall #B-357-9.

CODE
Unit #36LF06292.

MANUFACTURER
American Red Cross Blood Services, Columbia, South Carolina.

RECALLED BY
Manufacturer, by letter dated June 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
1 unit was distributed.

REASON
Blood product was manufactured from a unit of whole blood that may have been exposed to unacceptable temperatures during shipment.

________
PRODUCT
Corneas. Recall #B-367-9.

CODE
Tissue Donor Numbers: 96-2-4514, 96-4-4737, 95-8-4028, 95-12-4337.

MANUFACTURER
Rochester Eye and Human Parts Bank, Rochester, New York.

RECALLED BY
Manufacturer, by letter dated October 15, 1998 or November 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Michigan, New York, Pennsylvania, Syria.

QUANTITY
-------

REASON
Corneas were from a donor who tested initially reactive for HBSAG.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Platelets. Recall #B-297-9.

CODE
Unit numbers: 0477305, 0477306, 0477308, 0477309, 0477310, 0477311, 0477312, 0477313, 0477315, 0477316, 0477317, 0477319, 0477320.

MANUFACTURER
Blood Bank of Delaware, Newark, Delaware.

RECALLED BY
Manufacturer, by letter dated January 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Delaware and Maryland.

QUANTITY
13 units were distributed.

REASON
Blood products were stored at an unacceptable temperature.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitate; e) Recovered Plasma, for Further manufacturing.; F) Recovered plasma, for Non-Injectables. Recall #B-321/326-9.

CODE
Unit numbers: a) 5013855, 5022484, 8004470, 5000521; b) 5013855, 5022484, 8004470; c) 8004470; d) 5013855; e) 5022484; f) 5000521, 5013855.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

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

DISTRIBUTION
Ohio and Florida.

QUANTITY
a) 4 units; b) 3 units; c) 1 unit; d) 1 unit; e) 1 unit; f) 2 units were distributed.

REASON
Blood products tested negative for anti-HCV, but were collected from two donors who had previously tested positive for anti-HCV.

________
PRODUCT
Red Blood Cells. Recall #B-348-9.

CODE
Unit numbers: 53F20941, 53F20944, 53F20945, 53F20946.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by telephone on June 26, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland.

QUANTITY
4 units were distributed.

REASON
Blood products were labeled with extended expiration dates.

________
PRODUCT
a) HIV-1 Western Blot Kit; b) OrasSure HIV-1 Western Blot Kit. Recall #B-358-9.

CODE
Lot numbers: a) M0416801, M0331801, M0414801, 430 Kits M0430801; b) Lots: M0601801, M0603801.

MANUFACTURER
Epitope, Inc., Beaverton, Oregon.

RECALLED BY
Manufacturer, by letter dated July 27, 1998, and by telephone on July 30, 1998, and by letter dated July 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
North Carolina, California, Delaware, Kansas, Louisiana, New Jersey, Pennsylvania, Texas, District of Columbia.

QUANTITY
a) 430 kits; b) 146 kits were distributed.

REASON
Test kits were subjected to extended transit times, and therefore lack assurance of proper storage conditions.

________
PRODUCT
a) Platelets, Pheresis; b) Fresh Frozen Plasma, Pheresis. Recall #B-361/362-9.

CODE
Unit #3173909.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by fax on June 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who exceeded the donation acceptance criteria for body temperature.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

________
PRODUCT

Automatic Implantable Cardioverter Defibrillators:
a)  Model No. 1762, VENTAK MINI II Automatic Implantable
Cardioverter Defibrillators; 
b) Model No. 1763, VENTAK MINI II Automatic Implantable
Cardioverter Defibrillators; 
c) Model No. 1782, VENTAK MINI III Automatic Implantable
Cardioverter Defibrillators; 
d) Model No. 1783, VENTAK MINI III Automatic Implantable
Cardioverter Defibrillators; 
e) Model No. 1786, VENTAK MINI III Automatic Implantable
Cardioverter Defibrillators; 
f) Model No. 1810, VENTAK AV Automatic Implantable Cardioverter
Defibrillators; 
g) Model No. 1820, VENTAK AV II Automatic Implantable
Cardioverter Defibrillators; 
h) Model No. 1821, VENTAK AV II DR Automatic Implantable
Cardioverter Defibrillators.  Recall #Z-258/265-9.
CODE
 
Serial numbers:  a) 609561, 609676, 610139, 610397, 610401,
610417; b) 805493, 805508; c) 500401; d) 600337, 600211, 600315,
600530; e) 700085; f) 305371; g) 100134; h)202885, 202917,
202947, 203396, 205349, 206215, 206241, 206244, 206305, 208007,
210309, 210883, 210978, 213511.

MANUFACTURER
Guidant Corporation, Cardiac Pacemakers, St. Paul, Minnesota.

RECALLED BY
Manufacturer, by letter sent beginning November 4, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
32 of the defibrillators, each containing a chip carrier remarked by laser had been implanted.

REASON
The pacemakers may cease functioning without warning due to a compromised hermetic seal on a chip carrier component part.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
Heparin and Saline Luer Slip and Leur Lock Flush Syringes: a) Heparin (1 unit/mL) in 0.2% Sodium Chloride Flush Syringe; b) Heparin (10 and 100 units/mL) in Normal Saline Flush Syringe; c) Normal Saline, 0.9% NaCI, Flush Syringe. Recall #Z-255/257-9.

CODE
All lot numbers starting with AC13.

MANUFACTURER
Central Admixture Pharmacy Services (CAPS), Livonia, Michigan.

RECALLED BY
Central Admixture Pharmacy Services, Inc., Irvine, California, by letter dated November 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
California, Colorado, Connecticut, Indiana, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, New Hampshire, New York, Ohio, Pennsylvania, Texas, Vermont, Washington state, Wisconsin.

QUANTITY
136,790 syringes were distributed.

REASON
Some of the devices were contaminated with Enterobacter cloacae.

________
PRODUCT

Blood Collection and Reinfusion Devices
a) Stryker CBC Blood Conservation Kit with 1/8" Round PVC Wound
Drain, Part No. 215-414;
b) Stryker CBC Blood Conservation Kit with 1/4" Round PVC Wound
Drain, Part No. 215-416;
c) Stryker CBC Blood Conservation Kit with 3/16" Round PVC Wound
Drain, Part No. 215-426;
d) Stryker CBC Blood Conservation Reservoir, Part No. 215-28;
e) Stryker Constavac 800 cc Drainage Kit with 1/8" Round PVC
Wound Drain, Part No. 215-814;
f) Stryker Constavac 800 cc Drainage Kit with 1/4" Round PVC
Wound Drain, Part No. 215-816;
g) Stryker Constavac 800 cc Drainage Kit with 3/16" Round PVC
Wound Drain, Part No. 215-826;
h) Stryker Constavac 800 cc Kits, Part Nos. 215-87, 215-087S1 and
215-087S2;
I) Stryker CBC Replacement Filter, Part No. 215-28-670;
j) Stryker CBC Wall Suction Kit, Adapter and Hanger, Part No.
215-28-670;
k) Stryker 1/8" Silicone Drain Adapter, Part No. 215-30-7; 
l) Stryker 3/16" Silicone Drain Adapter, Part No. 215-31-7;
m) Stryker 1/4" Silicone Drain Adapter, Part No. 215-32-7;
n) Stryker Bilateral Evacuator Tube Set, Part No. 215-89.
Recall #Z-276/289-9.

CODE
Lot numbers: 97051092 through 9810512.

MANUFACTURER
Stryker Puerto Rico, Arroyo, Puerto Rico.

RECALLED BY
Stryker Instruments, Division of Stryker Corporation, Kalamazoo, Michigan, by letter on October 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
4,888 units were distributed.

REASON
There is insufficient evidence to support that the sterilization dose is capable to achieve the specified sterility assurance level.

________
PRODUCT

Ohmeda DTX/Plus Disposable Pressure Monitoring Kits, used in
conjunction with a balloon catheter to monitor blood pressure
near the heart:
a) Catalog No. 5200-011; b) Catalog No. 5200-017; 
c) Catalog No. 072906-300-001; d) Catalog No. 5200-002; 
e) Catalog No. 5200-001; f) Catalog No. 072906-300-001.
Recall #Z-304/309-9.

CODE
Lot numbers: a) 9704D73311; b) 9704D71761; c) 9704E22731; d) 9704D73791; e) 9704A970011; f) 9703E22451.

MANUFACTURER
Ohmeda, Singapore PTE, Yishun, Singapore.

RECALLED BY
Ohmeda Medical Devices Division, BOC Group, acquired by Becton Dickinson Infusion Therapy, Murry Hill, New Jersey, by letter dated March 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Canada and Guam.

QUANTITY
250 units were distributed; firm estimates none remains on the market.

REASON
The transducers are subject to loss of pressure monitoring.

________
PRODUCT

Ohmeda DTX/Plus Disposable Pressure Monitoring Kits and
Blood Sampling Kits, used in conjunction with a balloon catheter
to monitor blood pressure near the heart:
a) Catalog Nos. 072906-300-003, 072906-300-004,
072906-300-011;
b) Catalog No. 072906-300-018; 
c) Catalog No. 072911-013-216;
d) Catalog Nos. 5200-017, 5200-027 (CONFIGURATION B), 5200-029
(CONFIGURATION B), 5200-030,  5200-031, 5200-032, 5200-033
(CONFIGURATION B), 5200-037, 5200-038 (CONFIGURATION B),
5200-041, 5200-046, 5200-047 (CONFIGURATION B), 5215-179,     
5215-180, 5217-038;
e) Catalog No. 5251-010-1, 5262-016, 5266-135, 5267-085,
5271-01-1;
f) Catalog Nos. 072906-310-001 (CONFIGURATION B), 072906-310-002.
Recall #Z-310/315-9.

CODE

a) Lot Numbers starting with 9511, 9512, 96, 97;
b) Lot Numbers starting with 9610, 9611, 9612, 97; 
c) Lot Numbers starting with 9511, 9512, 96, 97  (CONFIGURATION
B);
d) Lot Numbers starting with 9511, 9512, 96, 97;
e) Lot Numbers starting with 9705, 9706, 9707, 9708, 9709,9710,
9711, 9712;
f) Lot Numbers starting with  95JAN, 95FEB, 95MAR, 95APR, 95MAY,
95JUN, 9507, 9508, 9509, 9510, 9511, 9512, 96, 97 (CONFIGURATION
B).

MANUFACTURER
Ohmeda, Singapore PTE, Yishun, Singapore.

RECALLED BY
Ohmeda Medical Devices Division, BOC Group, acquired by Becton Dickinson, Infusion Therapy, Murry Hill, New Jersey, by letter dated March 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
74,175 units were distributed.

REASON
There may be pin holes in the film of the blister package, thereby, compromising the sterility of the devices.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Endolumina II Transilluminating System (ETS), 50 French and 56 French Etachable Tips: a) French 50 Catalog #E-5030; b) French 56, Catalog #E-5630. Recall #Z-195/196-9.

CODE
Lot numbers: a) 8 lots between B97ETO22 and S98ETO09; 8 lots between B97ETO20 and S98ETO10.

MANUFACTURER
BioEntrics, Carpinteria, California.

RECALLED BY
Manufacturer, by letters on October 20, 1998, and by fax on October 2, 1998. Firm initiated recall ongoing.

DISTRIBUTION
Nationwide and International.

QUANTITY
50 French-489, 56 French-528 units were distributed.

REASON
If the tip is turned to a sharp angle it may disconnect from its ball socket connection.

________
PRODUCT
Modified Leveen Needle Electrode, an electrosurgical element for coagulative necrosis of the soft tissue. Recall #Z-298-9.

CODE
072098 - 2.0 cm diameter, 12 cm long electrode 072098 & 072198 - 2.0 cm diameter, 15 cm long electrode 071998 & 051298 - 3.0 cm diameter, 12 cm long electrode 061698 & 071898 - 3.0 cm diameter, 15 cm long electrode 051198 - 3.5 cm diameter, 12 cm long electrode 071798 & 061598 - 3.5 cm diameter, 15 cm long electrode.

MANUFACTURER
Radiotherapeutics Corp, Mountain View, California.

RECALLED BY
Manufacturer, by letter and telephone on November 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
378 units were distributed.

REASON
Sterility may be compromised as evidenced by a loss of package integrity.

________
PRODUCT
Irrivac-Max Suction Probes with Holes and Monopolar Electrodes: a) Model No. 200-40, 10 mm, 26 cm; b) Model No. 200-41, 5 mm 33 cm; c) Model No. 200-42, 10 mm, 33 cm; d) Model No. 200-43, Monopolar Electrodes Spatula Tip 5 mm 33 cm; e) Model No. 200-44, Monopolar Electrodes L Hook Tip 5 mm 33 cm; f) Model No. 200-45, Monopolar Electrodes J Hook Tip 5 mm 33 cm; g) Model No. 200-53, Monopolar Electrodes patula Tip 5 mm 45 cm; h) Model No. 200-54, Monopolar Electrodes L Hook Tip 5 mm 45 cm; I) Model No. 200-55, Monopolar Electrodes J Hook Tip 5 mm 45 cm; j) Model No. 200-56, Monopolar Electrodes Needle Tip 5 mm 45 cm; k) Model No. 200-57, Monopolar Electrodes Knife Tip 5 mm 45 cm; l) Model No. 200-58, Monopolar Electrodes, Button Tip 5 mm 45 cm. Recall #Z-318/329-9.

CODE
Lot numbers: a) 970520; b) 18015, 18156, 0605801, 0727801; c) 18137, 18157, 18711, 970520, 065022083; d) 18133, 065093071; e) 18017, 18134; f) 18018, 18135, 031897, 065093071; g) 18276; h) 18277; I) 18278; j) 97-0318-1, 970520; k) 97-0318-2; l) Lot No. 97-0318-3.

MANUFACTURER
U.S. Endo, Bensenville, Illinois.

RECALLED BY
Dexide, Inc., Fort Worth, Texas, by letter dated October 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
181 units were distributed.

REASON
Devices were distributed without an approved 510(k).

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Aeroview Introducer Sheath, Sterile: a) Aeroview Introducer Sheath, Sterile, Catalog No. Aero-117; b) Aeroview Introducer Sheath, Sterile, Catalog No. Aero-118. Recall #Z-266/267-9.

CODE
Lot numbers are #98043059, #98032593, #98022042, #98032483, and #97121176.

MANUFACTURER
Imagyn Medical Technologies, Inc., Costa Mesa, California.

RECALLED BY
Manufacturer, by letter on November 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
2,420 packages were distributed.

REASON
The labels for each lot failed to contain a caution statement that no other flexible endoscope is compatible with the Aeroview Introducer Sheath other than the one provided by the manufacturer.

End of Enforcement Report for DECEMBER 30, 1998.