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.


March 3, 1999                    99-09

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
Payco Guarito Coconut Twin Pop, 3 fluid ounces. Recall #F-211-9.

CODE
None.

MANUFACTURER
Helados Bon CXA, Santo Domingo, Dominican Republic.

RECALLED BY
Payco Foods, Inc., Bayamon, Puerto Rico, by telephone on January 22 & 23, 1999. Firm-initiated recall complete.

DISTRIBUTION
Puerto Rico.

QUANTITY
Undetermined.

REASON
Product is contaminated with Listeria monocytogenes and Salmonella.

________
PRODUCT
Alfalfa sprouts and sprout mixes: a) Alfalfa Sprouts, in 6 ounce "clam shell" containers, 1 pound plastic trays, and in 2 pound cardboard cases; b) Salad Sprouts (alfalfa/radish/clover), packed in 6 ounce "clam shell" containers; c) Onion-Alfalfa Sprouts, packed in 6 ounce "clam shell" containers. Recall #F-212/214-9.

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

MANUFACTURER
Hydro Harvest Ltd., Brush Prairie, Washington.

RECALLED BY
Manufacturer, by telephone and by press release on February 12, 1999. Firm-initiated recall complete.

DISTRIBUTION
Oregon, Washington state, California, Idaho.

QUANTITY
Approximately 3,000 - 3,500 units of sprouts are distributed every other day.

REASON
Products were associated with an outbreak of salmonellosis.

_______
PRODUCT
Elephant brand Whole Pitted Dried Malatya Apricots, in 28 pound boxes. Product of Turkey. Recall #F-215-9.

CODE
Lot #2-4015 1998.

MANUFACTURER
Figsan Dis Ticaret Ltd., Izmir, Turkey.

RECALLED BY
Trans Mid-East Shipping & Trading Inc., Brooklyn, New York, by telephone on November 20, 1998, and by press release on November 25, 1998. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York, Massachusetts, Pennsylvania, Georgia, Connecticut, Michigan, New Jersey.

QUANTITY
76 cartons were distributed.

REASON
Product contained undeclared sulfites.

________
PRODUCT
Gabila's brand Knishes in various packaging types and net weights. Recall #F-216-9.

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

MANUFACTURER
Gabila & Sons Manufacturing, Inc., Brooklyn, New York.

RECALLED BY
Manufacturer, by letter and visit on October 1, 1998. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York, New Jersey, Michigan, Connecticut, Florida.

QUANTITY
Approximately 250,000 pounds were distributed.

REASON
Product contained undeclared eggs, FD&C Yellow No. 5, and FD&C Yellow No. 6.

________
PRODUCT
Pimento Cheese Spread packaged in 3 pound, 5 pound and 10 pound containers. Recall #F-217-9.

CODE
Use by JAN 30 1999.

MANUFACTURER
Harold Food Company, Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter on January 7, 1999. Firm-initiated recall complete.

DISTRIBUTION
North Carolina and South Carolina.

QUANTITY
24 10-pound containers, 12 5-pound containers, and 4 3-pound containers were distributed.

REASON
Product is contaminated with Listeria monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT
General Mills Franken Berry Artificial Strawberry Flavor Frosted Cereal with Strawberry Marshmallows, in 12 ounce boxes. Recall #F-181-9.

CODE
Printed on the tops of recalled retail boxes are "Better If Used by" dates of: 25JUL99WW and 26JUL99WW; On cases, the dates are: 19OCT8W, 20OCT8W, 20OCT8F, 21OCT8F, and 23OCT8J.

MANUFACTURER
General Mills, Inc., West Chicago, Illinois.

RECALLED BY
General Mills, Inc., Minneapolis, Minnesota, by letter on January 18, 1999. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
4,161 (12 retail boxes per case) were distributed.

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

________
PRODUCT
Rico Garlic in Oil, in 8 ounce (24 bottles per case), 16 ounce (12 bottles per case), 32 ounce (12 bottles per case) bottles Recall #F-210-9.

CODE
All product on market at time of recall (product is not coded).

MANUFACTURER
Rico Foods, Inc., Paterson, New Jersey.

RECALLED BY
Manufacturer, by telephone on July 17, 1998, followed by letter on July 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey and New York.

QUANTITY
Undetermined.

REASON
Product was prepared and packed under insanitary conditions whereby it may have been rendered injurious to health.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________
PRODUCT
Egg Noodles in 5 pound plastic bags. Recall #F-208-9.

CODE
None.

MANUFACTURER
Mei Lake Noodle, Inc., New York, New York.

RECALLED BY
Manufacturer, by letter on August 19, 1998. Completed recall resulted from sample analysis and follow-up by the New York Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
Firm estimates none remains on the market.

REASON
The product did not meet the standard of identity for this product as specified in 21 CFR 139.150. Specifically, the product contained FD&C Yellow No. 5 and FD&C Yellow No. 6 which are not allowed as ingredients in this standardized food.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS III

________
PRODUCT
Hugo Woman Fine Fragrance Gift Sets. The set consists of a 12 inch long cylindrical metal canister containing one (1) 40ml glass bottle of Eau de Toilette Spray; and one (1) 150ml plastic tube of Body Lotion. Recall #F-209-9.

CODE
Batch Code #U8235373, SKU #06095995, UPC #737052105949.

MANUFACTURER
The Procter & Gamble Company Shulton, The Netherlands (assembler/responsible firm).

RECALLED BY
The Procter & Gamble Company, Cincinnati, Ohio, by letter faxed on October 7-8, 1998, followed by telephone beginning on October 12, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
1,700 gift sets were distributed.

REASON
The product is misbranded. The outer tag of the gift set identifies the contents as eau de toilette spray and body lotion when it actually contains eau de toilette spray and shower gel.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

________
PRODUCT

Rx Dental anesthetics in blister packed cartridges, under the
following labels:  Novocol, Henry Schein, or Carlisle:
a) Lidocaine Hydrochloride 2% and Epinephrine Injection, USP
1:50,000; 
b) Lidocaine Hydrochloride 3% and Epinephrine Injection, USP
1:100,000;
c) Mepivacaine Hydrochloride Injection, USP 3%;
d) Mepivacaine Hydrochloride 2% and Levonordefrin Injection, USP.
1:20,000.  Recall #D-119/122-9.

CODE
Lot numbers: a) 7412B, 7412C, 8081, 8207, 8159, 8161B; b) 7102, 7182, 7284, 7270A, 7309, 8157, 8162A, 8162, 8163, 8164, 8249; c) 7157; d) 7412A, 8160.

MANUFACTURER
Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada.

RECALLED BY
Novocol Pharmaceutical of Canada, Inc., New castle, Delaware, by letter on January 14-15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Undetermined.

REASON
Microbial contamination.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
Triprolidine Hydrochloride and Pseudoephedrine Hydrochloride Syrup USP (1.25mg/5mL and 30mg/5mL) in 4 fluid ounce bottles, OTC oral liquid nasal decongestant/antihistamine, under the Morton Grove Pharmaceuticals (MGP) (NDC #60431-600-04) and Goldline, (NDC #0182-1609-37) labels. Recall #D-124-9.

CODE
Lot numbers: 21377A, 21377C, 21377E, 21377F EXP 07/99.

MANUFACTURER
Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois.

RECALLED BY
Manufacturer, by letter dated February 2, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
14,430 bottles were distributed; firm estimated that little, if any, product remained on market at time of recall initiation.

REASON
Potency failure (triprolidine HCL) during stability testing.

________
PRODUCT

Generic pre-filled syringes aseptically manufactured and
distributed by Medefil:
a) 0.9% Sodium Chloride Injection, USP, Preservative Free
   2ml fill in 3 ml syringe - NDC #64253-777-12;
   5 ml fill in 6 ml syringe - NDC #64253-777-25;
   10 ml fill in 12 ml syringe - NDC #64253-777-30;
   5 ml fill in 12 ml syringe - NDC #64253-777-35;
b) Heparin Sodium 10 units/ml in 0.9% Sodium Chloride Injection,
   USP, 5 ml fill in 12 ml syringe - NDC #64253-666-35;
c) Heparin Sodium 100 units/ml in 0.9% Sodium Chloride Injection
   USP
   3ml fill in 6 ml syringe - NDC #64253-555-23;
   5 ml fill in 6 ml syringe - NDC #64253-555-25;
   10 ml fill in 12 ml syringe - NDC #64253-555-30;
   5 ml fill in 12 ml syringe - NDC #64253-555-35.
Recall #D-126/128-9.

CODE
All lots: S00005, S00006, S00007, S00008, S00009, S00010, S00011, S00012, S00013, S00014, S00015, S00017, S00018, S00019, S00020, S00021, S00022, S00023, S00024, S00025, H00005, H100005, H100006, H100007, H100008, H100009.

MANUFACTURER
Medefil, Inc., Schaumburg, Illinois.

RECALLED BY
Manufacturer, by letter dated February 8, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Ohio.

QUANTITY
a) 1,532 cases; b) 25 cases; c) 262 cases were distributed between 12/18/98 and 1/28/99; firm estimated that 50% of the product remained on the market at time of recall initiation.

REASON
Products were marketed without approved (NDA/ANDA) and numerous deviations from current good manufacturing practices (GCMP's) related to sterile drug production.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
Isoniazid Tablets, USP, 300 mg, in 30, 100, and 1,000 tablet bottles, Rx intended for all forms of tuberculosis in which organisms are susceptible, under the following labels: Barr, Schein, Rugby, UDL. NDC numbers: 0555-0071-01, 0555-0071-02, 0555-0071-05. Recall #D-123-9.

CODE
Lot numbers: 5L071AL, 6A071AL, 6A071AM, 6B071CO, 6C071AT, 6D071AB, 6D071AZ, 6D071BA, 6E071CB, 6E071CC, and 6E071AE EXP 5/99.

MANUFACTURER
Barr Laboratories, Inc., Northvale, New Jersey.

RECALLED BY
Barr Laboratories, Inc., Pomona, New York, by letter beginning on January 8, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
288,549 containers were distributed.

REASON
Dissolution failure (stability).

________
PRODUCT
Nalex DH, Rx antitussive and decongestant, (Hydrocodone Bitartrate 1.67 mg/5mL/Phenylephrine Hydrochloride 5 mg/5mL), in 16 fluid ounce bottles, distributed by Blansett Pharmacal Co., Inc., (BPCI). NDC #51674-0005-7. Recall #D-125-9.

CODE
Lot #91638 EXP 10/2000.

MANUFACTURER
Great Southern Laboratories (GSL), Houston, Texas.

RECALLED BY
Manufacturer, by letter dated February 2, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
6,506 bottles were distributed.

REASON
Mislabeling - Some bottles have the incorrect (Nalex A) insert attached.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Platelets, Pheresis. Recall #B-359-9.

CODE
Split unit #KZ53096.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by telephone on August 18, 1998, and by letter dated August 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
1 split unit was distributed.

REASON
Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation.

_______
PRODUCT
Red Blood Cells. Recall #B-360-9.

CODE
Unit #1696100.

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

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

DISTRIBUTION
Mississippi.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who had been deferred because of treatment for gonorrhea.

________
PRODUCT
Platelets, Pheresis. Recall #B-509-9.

CODE
Unit #0530650.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by telephone on November 5, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY
1 unit was distributed.

REASON
Blood product was resuspended in saline instead of plasma.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-511/513-9.

CODE
Unit #1035424.

MANUFACTURER
Sioux Valley Hospital Association, Sioux Falls, South Dakota.

RECALLED BY
Manufacturer, by telephone on November 24, 1996, and by fax on November 22, 1996. Firm-initiated recall complete.

DISTRIBUTION
South Dakota and California.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of cancer.

________
PRODUCT
Platelets. Recall #B-514-9.

CODE
Unit #0578147.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by telephone on May 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
Red Blood Cells. Recall #B-515-9.

CODE
Unit #433557.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated January 7, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who traveled to an area considered endemic for malaria and took antimalarial medication.

________
PRODUCT
Platelets, Pheresis. Recall #B-519-9.

CODE
Unit #0531814.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by telephone on October 21, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an incorrect platelet count.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Single Donor Plasma; e) Cryoprecipitate AHF; f) Recovered Plasma. Recall #B-520/525-9.

CODE
Unit numbers: a) 363841, 390067, 390792, 409984, 437872, 453792; b) 390792, 437872, 453792; c) 409984, 453792; d) 363841; e) 363841; f) 390792, 437872, 390067.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letters dated February 4, 1997, April 15 or 16, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota, Florida and Switzerland.

QUANTITY
a) 6 units; b) 3 units; c) 2 units; d) 1 unit; e) 1 unit; f) 3 units were distributed.

REASON
Blood products were collected from donors who previously reported body fluid exposure, travel to a malarial endemic area, tattoo, incarceration, cancer, or receipt of radioactive iodine, and were not deferred.

________
PRODUCT
Recovered Plasma. Recall #B-527-9.

CODE
Unit #13261.

MANUFACTURER
St. Thomas More Hospital, Canon City, Colorado.

RECALLED BY
Manufacturer, by letter dated July 2, 1998, and on July 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Colorado and Florida.

QUANTITY
1 unit was distributed.

REASON
Blood product was incorrectly tested for antibody to the human immunodeficiency virus types 1 and 2 (anti-HIV-1/2).

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-528/529-9.

CODE
Unit #0273667.

MANUFACTURER
Central Jersey Blood Center, Shrewsbury, New Jersey.

RECALLED BY
Manufacturer, by telephone, letter, and/or fax on July 8, 1998, and by letter dated July 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who took the drug Accutane within 30 days of donation.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-533/535-9.

CODE
Unit numbers: a) 0624826, 0671552, and 0768025; b) 0671552 and 0768025; c) 0624826, 0671552, and 0768025.

MANUFACTURER
Central Kentucky Blood Center, Lexington, Kentucky.

RECALLED BY
Manufacturer, by letters dated December 31, 1998. Firm-initiated recall complete.

DISTRIBUTION
Kentucky and Pennsylvania.

QUANTITY
a) 3 units; b) 2 units; c) 3 units were distributed.

REASON
Blood products were collected from a donor who previously tested reactive for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Source Plasma, for Manufacturing In Vitro Diagnostic Products. Recall #B-205-9.

CODE
Unit Numbers: G-88036-056, G-18249-141, G-16742-141, G-18400-141, G-17283-141, G-68197-061, G-62631-070, N-28429-076, N-28517-076, G-26366-076, G-96408-107, G-95935-079, G-72567-061, G16604-141.

MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, California.

RECALLED BY
Manufacturer, by letters dated July 29, 1998, August 5, 27, and 28, 1998, September 4 and/or 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
California and Virginia.

QUANTITY
14 units were distributed.

REASON
Source Plasma was collected from unsuitable donors, or from donor who were not properly screened.

________
PRODUCT
Source Plasma. Recall #B-510-9.

CODE
Unit #XB43469.

MANUFACTURER
Community Bio-Resources, Inc., St. Cloud, Minnesota.

RECALLED BY
Manufacturer, by fax on August 20, 1997. Firm-initiated recall complete.

DISTRIBUTION
California.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor whose medical history screening was not performed at the time of donation.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-516/518-9.

CODE
Unit #454877.

MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.

RECALLED BY
Manufacturer, by letter dated June 19, 1997. Firm-initiated recall complete.

DISTRIBUTION
Minnesota.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had a corneal transplant.

________
PRODUCT
Platelets, Pheresis. Recall #B-526-9.

CODE
Unit #40P64518.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by letter dated February 1, 1999. Firm-initiated recall complete.

DISTRIBUTION
Iowa.

QUANTITY
1 unit was distributed.

REASON
Unlicensed blood product was distributed interstate.

________
PRODUCT
Cryoprecipitated AHF. Recall #B-530-9.

CODE
Unit #40GL70323.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED BY
Manufacturer, by telephone on December 11, 1998, followed by letters dated December 15, 1998, and January 18, 1999. Firm-initiated recall complete.

DISTRIBUTION
Tennessee.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a unit of whole blood with an extended collection time.

________
PRODUCT
AFFIRMAGEN Reagent Red Blood Cells. Recall #B-531-9.

CODE
Lot A319, Expiration Date: 8/25/98.

MANUFACTURER
Ortho Clinical Diagnostics, Inc., Raritan, New Jersey.

RECALLED BY
Manufacturer, by letter dated July 22, 1998, followed by telephone or fax. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
666 packages were distributed.

REASON
Reagent red blood cells were packaged in cartons with incorrect product labels.

________
PRODUCT

Reagent Red Blood Cells:
SELECTOGEN Reagent red blood cells; 
SURGISCREEN Reagent red blood cells; 
RESOLVE PANEL Reagent red blood cells;
Expiration date:  7/21/98, 608 packages.  
Recall #B-532-9.

CODE
SELECTOGEN Reagent red blood cells, Lot S771 EXP 7/28/98; SURGISCREEN Reagent red blood cells, Lot 3SS482 EXP 9/9/98; RESOLVE PANEL Reagent red blood cells, Lot RA117 EXP 7/21/98.

MANUFACTURER
Ortho Clinical Diagnostics, Inc., Raritan, New Jersey.

RECALLED BY
Manufacturer, by letters dated July 13, 1998, or by telephone on August 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
SELECTOGEN Reagent red blood cells, 406 packages SURGISCREEN Reagent red blood cells, 166 packages RESOLVE PANEL Reagent red blood cells, 608 packages.

REASON
Reagent red blood cells exhibited a weak and/or inconsistently reactive positive direct antiglobulin test (DAT), when used with the ID-Micro Typing System MTS Anti-IgG Card (gel test).

________
PRODUCT
Source Plasma. Recall #B-536-9.

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

MANUFACTURER
Sera-Tec Biologicals Limited Partnership, Pittsburgh, Pennsylvania.

RECALLED BY
Manufacturer, via dispatcher on May 1, 1996. Firm-initiated recall complete.

DISTRIBUTION
Units were returned before they reached their destination.

QUANTITY
324 units were released for transport service. Firm estimates none remains in commerce.

REASON
Blood products were distributed prior to the receipt of viral marker test results.

_______
UPDATE
Recall #B-480-9, Red Blood Cells (Central Indiana Regional Blood Center, Inc.) which appeared in the February 17, 1999 Enforcement Report should read: CODE
: Unit #2878258.

RECALLS AND FIELD CORRECTIONS: DEVICES: CLASS II

________
PRODUCT
Fresenius AS 104 Cell Separator. Recall #Z-592-9.

CODE
HMW 123, HMW 1231, IAW 305, IAW 3051, IBW 271, IBW 2711, ICW 206, ICW 2061, IDW 093, IDW 2422, IDW 2423.

MANUFACTURER
Fresenius Medical Care North America, Walnut Creek, California.

RECALLED BY
Manufacturer, by letter on or about September 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
3,410 sets (682 cases) were distributed.

REASON
There is a potential for kinking to occur in the PRC tubing.

________
PRODUCT
Alreco 40400. Recall #Z-595-9.

CODE
Compressor Compact Reorder #6150440 with serial number 20481 and lower except 20463.

MANUFACTURER
Allen Rehnstrom AB, Osterbagen, Sweden.

RECALLED BY
Siemens Medical Systems, Inc., Danvers, Massachusetts, by letter dated February 17, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
379 units were distributed.

REASON
Failure of secondary fuse F3 on Siemens Compressor compact stops gas delivery.

________
PRODUCT

Bayer Advia 120 Hematology System, a quantitative automated
hematology analyzer that provides a leukocyte differential count
and reticulocyte analysis for in-vitro diagnostic use in clinical
laboratories:
a) ADVIA 120 Hematology System Catalog #453-0024-03; 
b) ADVIA 120 Hematology System, Catalog #453-0024-04.
Recall #Z-615/616-9.

CODE
All Serial Numbers of the form 100XXX98YY, in which XXX is a sequential number from 100 to 799, inclusive, and YY is the week number of manufacture for November, 1997 through August 1998.

MANUFACTURER
Bayer Corporation, Elkhart, Indiana.

RECALLED BY
Manufacturer, by sending Product Change Notifications, Service Bulletins, and a Customer Bulletin beginning August 28, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 699 units were distributed.

REASON
The device may give false red blood cell and blood platelet counts.

________
PRODUCT
Abbott Alcyon(tm) 300 Analyzer (without Ise Module) and 3001, an automated chemistry analyzer for in vitro diagnostic use. Recall #Z-617-9.

CODE
List numbers: 4D66-02, 4D67-02, 4D68-02, 4D69-02.

MANUFACTURER
Abbott Laboratories, Irving, Texas.

RECALLED BY
Abbott Laboratories, Abbott Park, Illinois, by telephone on January 29, 1999, and by letter dated February 1, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
631 units were distributed.

REASON
Possible mixup of patient sample results.

________
PRODUCT
Collimator Cart of the Millennium Mg Computed Emission Tomography System. Recall #Z-618-9.

CODE
Collimator Cart Model #2173498. Affected units were distributed prior to May 1998.

MANUFACTURER
GE Medical Systems, Waukesha, Wisconsin. ELGEMS, Ltd Advanced Technology, CenterHaifa, Israel.

RECALLED BY
GE Medical Systems, Waukesha, Wisconsin by field modification instruction #40598 on January 20, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
77 carts were distributed.

REASON
Casters in the wheel assemblies of the collimator cart can fall off, allowing the collimator cart to tip over.

________
PRODUCT
PERM-CATH Catheters: a) 36cm Catheter Insertion Tray Part #88-17680-001; b) 40cm Catheter Insertion Tray Part #88-17681-001; c) 36cm Catheter Kit Part #88-17748-001; d) 40cm Catheter Kit Part #88-17749-001; e) 45cm Catheter Kit Part #88-31692-001. The kits contain a limited amount of surgical products, the trays contain all surgical products needed for surgery. Recall #Z-634/638-9.

CODE
Lot numbers: a) 802453, 802712; b) 802454, 802575, 802482; c) 802455, 802456, 802457, 802576; d) lots 802458, 802577; e) lots 802278, 802591.

MANUFACTURER
The Kendall Company, Bothell, Washington.

RECALLED BY
Manufacturer, by letter sent on or about February 10-11, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 9,536 Percaths were distributed: a) 757 trays; b) 3,764 trays; c) 3,630 kits; d) 820 kits; e) 565 kits.

REASON
The introducer sheath would not separate as intended upon completion of catheter insertion procedure.

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PRODUCT
Disposable Administration Set for Peritoneal Dialysis, a sterile, single use only fluid pathway for use with the Home Care Automated PD System only. Recall #Z-639-9.

CODE
Catalog #5C4469, Lot numbers: H98J26529, H98J26537, H98J27527, H98K30537, H98L02526, H98J27535, H98J28525, H98J28533, H98K30545, H98L02583, H98J28541, H98J29523, H98J30588, H98L01528, H98L03581, H98K02585, H98K03583, H98K04581, H98L01536, H98L04589.

MANUFACTURER
Baxter Healthcare Corporation, Mountain Home, Arkansas.

RECALLED BY
Baxter Healthcare Corporation, Deerfield, Illinois, by letter dated February 4 and 5, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
93,720 sets were distributed.

REASON
The sets may restrict fluid delivery due to an obstruction in the cassette, which may result in alarm situations that will not allow patients to proceed with therapy.

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PRODUCT
Digital Gamma Camera Systems, used to autoposition the patient: a) Model No. GCA-7100A; b) Model No. GCA-7100A/DI; c) Model No. GCA-7100A/UI; d) Model No. GCA-7200A; e) Model No. GCA-7200A/DI; f) Model No. GCA-7200A/UI. Recall #Z-661\666-9.

CODE
145 nonsequential serial numbers.

MANUFACTURER
Toshiba Corporation, NASU Works, Tochigi, Japan.

RECALLED BY
Toshiba America Medical Systems, Inc., Tustin, California, by letter on December 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
145 units were distributed.

REASON
The product was manufactured with methods that resulted in the detector's motion not stopping, and therefore, the patient may receive an injury from the force.

________
PRODUCT
Sodium Hyaluronate FB, a sterile visco-elastic material that is injected into the eye during certain ophthalmic surgeries: a) Amvisc Product No. 780 (Sodium Hyaluronate FB); b) Amvisc Plus Product No. 850 (Sodium Hyaluronate FB); c) Amvisc Plus Product No. 880 (Sodium Hyaluronate FB). Recall #Z-667/669-9.

CODE
All serial numbers.

MANUFACTURER
Lifecore Biomedical, Inc., Chaska, Minnesota.

RECALLED BY
World Optics, Agoura, California, by fax on January 18, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Arkansas, California, Idaho, Florida, Minnesota, Pennsylvania, Texas, Utah.

QUANTITY
4,872 units were distributed.

REASON
The devices were marketed without an approval PMA.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
1/2 cc U100 Insulin Syringes with 28G x 1/2". Recall #Z-593-9.

CODE
Product No. 321-4106, Lot #970721.

MANUFACTURER
Shina Corporation, Seoul, Korea.

RECALLED BY
Medi-Hut Company, Inc., Lakewood, New Jersey, by fax and UPS in December 1997, and by letter on December 23, 1997. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
180,000 units were distributed.

REASON
The poly bag is mislabeled as 1cc syringe, but the correct 1/2 syringes are inside that bag, which is inside the correctly labeled boxes.

________
PRODUCT
Aeroset System Reagent Application Sheet for Urine/CSF Protein Reagent, used for the quantitation of total protein in human urine or cerebrospinal fluid (CSF). Recall #Z-596-9.

CODE
List #07D79-01.

MANUFACTURER
Abbott Laboratories, Irving, Texas.

RECALLED BY
Abbott Laboratories, Abbott Park, Illinois, by telephone on January 25, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
176 units were distributed.

REASON
Depressed protein concentrations in the range between 200 and 600 mg/dL.

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PRODUCT
Scimed Owens Lo-Profile Balloon Dilatation Catheters: a) Model H74926140; b) Model H74926150; c) H74926160; d) H74926170. Recall #Z-619/622-9.

CODE
Lot numbers: a) 1875484, 1984517, and 2051216; b) 1875485, 1890301, 1999830, and 2032596; c) 1850364 and 1929297; d) 1819312, 1860969, 1921073, and 1965812.

MANUFACTURER
Scimed Life Systems, Inc., Maple Grove, Minnesota.

RECALLED BY
Manufacturer, by letter sent on February 5, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
170 units were distributed.

REASON
Improper assembly of the devices makes them unusable.

________
PRODUCT
Premier C. Difficile, diagnostic test kits, an enzyme immunoassay for the detection of C. difficile Toxin A in stool specimen. This test kit is intended for use as an aid in the diagnosis of C. difficile-associated disease. Recall #Z-640-9.

CODE
LOT #601096.155.

MANUFACTURER
Meridian Diagnostics, Inc., Cincinnati, Ohio.

RECALLED BY
Manufacturer, by letter on February 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
2,158 kits were distributed.

REASON
Bacterial contamination of sample diluent, which may affect test results.

MEDICAL DEVICE SAFETY ALERTS:

________
PRODUCT
Hewlett Packard M2475B Codemaster 100 Defibrillator/Monitor powered by the Nickel Cadmium (NiCd) Rechargeable Batteries. Safety Alert #N-004-9.

CODE
HP Part No. M2476B-2.5 Amp-hr and M2477B-4-.0 Amp-hr.

MANUFACTURER
Hewlett Packard Company, Andover, Massachusetts.

ALERTED BY
Manufacturer, by medical device safety alert on December 12, 1998.

DISTRIBUTION
Nationwide and international.

QUANTITY
3,815 units were distributed.

REASON
Rechargable NiCad batteries used beyond shelf-life of 2 years may not function.

END OF ENFORCEMENT REPORT FOR MARCH 3, 1999.

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