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 16, 1998
98-50

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
a) Hormel Quick Meal Cheeseburger; b) Hormel Quick Meal Hamburger; c) Hormel Quick Meal Bacon Cheeseburger. Recall #F-083/085-9.

CODE
a) 09248EX (where X = 1 - 6) was recalled on October 6, 1998. On October 30, 1998, the recall was expanded to all codes on the market as of October 30, 1998; b) All codes on the market as of October 30, 1998; c) All codes on the market as of October 30, 1998.

MANUFACTURER
Finished Product Sandwiches: Pierre Foods, Claremont, North Carolina.

RECALLED BY
Recalling Firm/Distributor/Manufacturer of Cooked Beef Patties: Hormel Foods Corporation, Austin, Minnesota, by press release and letter on October 30, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
185,000 cases (each case containing 12 individually packaged sandwiches) were distributed.

REASON
Products may be contaminated with Listeria monocytogenes.

________
PRODUCT
Mrs. Giles Homestyle Tuna Salad, Net Weight 3 pounds. Recall #F-087-9.

CODE
10/6/98.

MANUFACTURER
Mrs. Giles Country Kitchens, Inc., Lynchburg, Virginia.

RECALLED BY
Manufacturer, by press release and by letter faxed on September 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Alabama, Florida, Georgia, Virginia, North Carolina, South Carolina, Tennessee, Texas.

QUANTITY
548 cases (2 containers per case) were distributed.

REASON
Product was contaminated with Listeria monocytogenes.

________
PRODUCT
Big Value Vanilla Sandwich Cremes Cookies, in 24 ounce cellophane packages. Recall #F-088-9.

CODE
Jan 16 99 JS.

MANUFACTURER
Vista Bakery, Inc., Burlington, Iowa.

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

DISTRIBUTION
Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, North Carolina, Ohio, South Carolina, Virginia, Tennessee, Texas, West Virginia.

QUANTITY
1,360 cases (12 packages per case) were distributed.

REASON
Some packages of cookies actually contain peanut butter sandwich creme cookies. Peanuts are not declared on the label.

________
PRODUCT

Cheeseburgers:  a) Jimmy Dean Foods Flavor Cravers brand Flame
Broiled Cheeseburgers, 2 cheeseburgers in a clear plastic
package, net. wt. 4.8 oz.  Item #11624;
b) Jimmy Dean Foods Flavor Cravers brand Flame Broiled Bacon
Cheeseburger, 1 cheeseburger in a clear plastic package, net. wt.
6.2 oz.  Item #20337;
c) Jimmy Dean Foods Flavor Cravers brand Flame Broiled Double
Cheeseburger, 1 cheeseburger in a clear plastic package, net. wt.
8.1 oz.  Item #20336.  Recall #F-092/094-9.

CODE

Lot numbers:  a) 1038-8    1098-8   1178-8    1287-8   3087-8
b) 1258-8    1277-8   3017-8;
c) 1109-8    1168-8   1258-8    1267-8   3017-8.

MANUFACTURER
Manufacturer of finished product (cheeseburgers): Jimmy Dean Foods, Florence, Alabama; Hamburger Patty Supplier: Zartic, Inc., Cedartown, Georgia.

RECALLED BY
Jimmy Dean Foods, Cordova, Tennessee, by fax on October 12, 1998, and by press release on October 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
a) 2,912 cases; b) 672 cases; c) 2,765 cases were distributed.

REASON
The products were manufactured with beef patties that may be contaminated with Salmonella.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT
Vacuum Packed Enoki Mushrooms, in polybags approximately 3.5 ounces. Recall #F-030-9.

CODE
None.

MANUFACTURER
Bruno's, Inc., Birmingham, Alabama.

RECALLED BY
Manufacturer, on April 15, 1998 and by fax on April 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Tennessee, Alabama, Florida, Georgia, Mississippi.

QUANTITY
Undetermined.

REASON
Product was inadvertently packaged in pouches with no English labeling. Hence, the product's label fails to bear all mandatory information as required by 21 CFR 101.15(c)(1). This resulted in the label failing to bear English instructions to "keep refrigerated" which is necessary to prevent a botulism hazard in this type of product.

________
PRODUCT
Three Treasures of Guilin Bean Curd, in 6 ounce glass jars. Recall #F-089-9.

CODE
Lot #SB7680.

MANUFACTURER
Guilin Soybean Cheese Factory in Guangxi, Guilin Guangxi, China.

RECALLED BY
Fortuner's Food Company, Inc., Brooklyn, New York, by letter on September 5, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
8 cases (60 jars per case) were distributed.

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

________
PRODUCT
Preserved Bean Curd, in 10 ounce glass jars. Recall #F-090-9.

CODE
None.

MANUFACTURER
Guilin Soybean Cheese Factory in Guangxi, Guilin Guangxi, China.

DISTRIBUTION
New York.

QUANTITY
32 cases (36 jars per case) were distributed.

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

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________
PRODUCT
Zu Miao brand Black Bean Curd with Salt, in 16 ounce flexible plastic bags. Recall #F-082-9.

CODE
None.

MANUFACTURER
Fushan Foodstuffs Import & Export Company of Guangdong, Guangdong, China.

RECALLED BY
Fortuner's Food Company, Inc., Brooklyn, New York, by visit. Product was voluntarily destroyed on September 22, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
New York.

QUANTITY
2 cases (100 bags per case) were distributed.

REASON
Product is contaminated with filth.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_________
PRODUCT
a) Levothyroxine Sodium, USP, Tablets, 25 mcg (0.025 mg), Rx in 100 tablet bottles; b) Levothyroxine Sodium, USP, Tablets, 75 mcg (0.075 mg), Rx in 100 and 1,000 tablet bottles; c) Lexothyroxine Sodium, USP Tablets, 150 mcg (0.15 mg), in 100 and 1,000 tablet bottles. Levothyroxine Sodium Tablets are used as a replacement or supplemental therapy in patients with hypothyroidism and as a pituitary TSH suppressant in the treatment or prevention of various types of euthyroid goiters; d) Belladonna Alkaloids with Phenobarbital Tablets (Hyoscyamine Sulfate, USP 0.1037 mg/Atropine Sulfate, USP 0.0194 mg/Scolopamine Hbr 0.085 mg/Phenobarbital, USP 16.2 mg) in 100 and 1,000 tablet bottles; e) Phenobarbital, USP Tablets, 16.2 mg (1/4 gr) in 100 and 1,000 tablet bottles, used as sedatives and anticonvulsant for the treatment of generalized and partial seizures. Recall #D-024/028-9.

CODE

a) Levothyroxine Sodium 0.025mg Rx Tablets, lot #'s:
036077C, exp. 12/98 (NDC #0603-4192-21) 
036077D, exp. 12/98 (NDC #0254-3911-28) 
b) Levothyroxine Sodium 0.15mg Rx Tablets, lot #'s:
018047A, EXP 03/98 (NDC #0254-3915-28) 
018047B, EXP 03/98 (NDC #0603-4196-32)
018047C, EXP 03/98 (NDC #0254-3915-38)
c) Levothyroxine Sodium 0.075mg Rx Tablets, lot #'s:
008096A, EXP 10/98 (NDC #0603-4194-32) 
008096B, EXP 10/98 (NDC #0254-3913-38)
008096C, EXP 10/98 (NDC #0254-3913-28)
008096D, EXP 10/98 (NDC #0254-3913-28)
d) Phenobarbital/Belladonna Alkaloids Rx Tablets, lot #'s:
039116B, exp. 10/98 (NDC #0254-2320-38)
039116C, exp. 10/98 (NDC #0603-2418-21)
e) Phenobarbital USP 16.2mg (1/4gr) Rx Tablets, lot #'s:
077058B, EXP 06/00 (NDC #0254-5011-28)
077058D, EXP 06/00 (NDC #0254-5011-38).

MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letters dated August 14, 1998, and September 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama.

QUANTITY

1,872 bottles of Levothyroxine Sodium 0.025mg Rx Tablets, lot
#036077C.
2,080 bottles of Levothyroxine Sodium 0.025mg Rx Tablets, lot
#036077D.
1,584 bottles of Levothyroxine Sodium 0.075mg Rx Tablets, lot
#008096A.
724 bottles of Levothyroxine Sodium 0.075mg Rx Tablets, lot
#008096B.
1,171 bottles of Levothyroxine Sodium 0.075mg Rx Tablets, lot
#008096C.
3,599 bottles of Levothyroxine Sodium 0.075mg Rx Tablets, lot
#008096D.
1,301 bottles of Levothyroxine Sodium 0.15mg Rx Tablets, lot
#018047A.
1,711 bottles of Levothyroxine Sodium 0.15mg Rx Tablets, lot
#018047B.
992 bottles of Levothyroxine Sodium 0.15mg Rx Tablets, lot
#018047C.
894 bottles of Phenobarbital/Belladonna Alkaloids Rx Tablets, lot
#039116B.
1,436 bottles of Phenobarbital/Belladonna Alkaloids Rx Tablets,
lot #039116C.
4,121 bottles of Oxycodone/Acetaminophen, USP 5/500mg Rx
Capsules, lot #049097A. 
3,591 bottles of Phenobarbital USP 16.2mg (1/4gr) Rx Tablets, lot
#077058B.
2,167 bottles of Phenobarbital USP 16.2mg (1/4gr) Rx Tablets, lot
#077058D.

REASON
a-d) Inability to assure potency throughout expiration date. e) Possibility of cross contamination.

________
PRODUCT
Vecuronium Bromide for Injection, 20 mg vial (20mL Lyophilized Powder), Rx, under the Marsam Pharmaceuticals label. NDC #0209-9143-92. Recall #D-037-9.

CODE
Lot #98C280.

MANUFACTURER
Steris Laboratories, Inc., Phoenix, Arizona.

RECALLED BY
Manufacturer, by letter on October 26, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
8,930 vials were distributed.

REASON
Cross contamination with Triamcinolone Acetonide in trace amounts (7ppb).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
a) Oxycodone/Acetaminophen, USP 5/500mg Rx Capsules, in bottles of 100, indicated for the relief of moderate to moderately severe pain; b) Tricosal Tablets (Choline Magnesium Trisalicylate), 750 mg, in 100 tablet bottles, Rx, indicated for the relief of the sings and symptoms of rheumatoid arthritis, osteoarthritis, and other arthritides. Recall #D-029\030-9.

CODE
Lot numbers: a) 049097A, EXP 09/99 (NDC #0254-4832-28); 049097B, EXP 09/99 (NDC #0603-4997-21); b) 011047A, EXP 03/99 (NDC #0603-6216-21).

MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.

RECALLED BY
Manufacturer, by letter dated August 14, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama.

QUANTITY
a) 4,121 bottles of lot #049097A and 4,843 bottles of lot #049097B; b) 2,909 bottles were distributed.

REASON
a) Lack of assurance of blend uniformity. b) Dissolution failure (12 month stability).

________
PRODUCT
a) Arthoflex Max Topical Pain Relief for Arthritis, Joints & Sore Muscles, (Capsaicin 0.25%), 1.5 and 3.0 ounce plastic tubes; b) Arthroflex, Topical pain relief gel-external (Capsaicin 0.025%), in 2 ounce plastic tubes. Recall #D-035/036-9.

CODE
Lot numbers: a) 0808G, 0198G, 0178G, 0408G, 0168G, 0158G, 0218G, 3447G; b) 2897, 1717, 12297, 12097, 1267.

MANUFACTURER
Panef Corporation, Milwaukee, Wisconsin.

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

DISTRIBUTION
Nationwide.

QUANTITY
123,000 tubes were distributed.

REASON
Subpotent.

________
UPDATE
Recall #D-034-9, Phenylopropranolamine Hydrochloride 75 mg/Clorpheniramine Maleate 8, mg, repacked and distributed by Perrigo Company, Allegan, Michigan, which appeared in the December 9, 1998 Enforcement Report should read:
MANUACTURER: Schwarz Pharma Manufacturing, Inc., Seymour, Indiana.

RECALLED BY
: Manufacturer, by telephone on June 16, 1998, and by letter dated June 28, 1998. Firm-initiated recall ongoing.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Various Human Tissues for Transplant: Right Fibula, Left Fibula, Whole Right Femur, Whole Left Femur, Left Hemi-pelvis, Right Hemi-pelvis, Left Facia Lata, Right Facia Lata, Right Achilles+Cancellous+Talus, Left Achilles+Cancellous+Talus, Whole Left Tibia with BTB, and Whole Right Tibia with BTB. Recall #B-122-9.

CODE
Donor: 00411540.

MANUFACTURER
Osteotech, Inc., Eatontown, New Jersey.

RECALLED BY
Musculoskeletal Transplant Foundation (MTF), Edison, New Jersey, by telephone, and by letter dated June 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide.

QUANTITY
45 tissue units were distributed.

REASON
Various human tissues for transplant, procured from a donor who tested repeatedly reactive for the HIV-p24 antigen.

________
PRODUCT

a) Immune Globulin Intravenous (Human) Venoglobulin-S 10%
Solution; 
b) Immune Globulin Intravenous (Human) Venoglobulin-S 5%
solution; 
c) Antihemophilic Factor (Human) Detergent/heat treated; 
d) Coagulation Factor IX (Human), Alphanine; 
e) Factor IX Complex, Profiline SD; 
f) Albumin (Human), U.S.P.,  Albutein 25%;
g) Alpha 1 Proteinase Inhibitor (Human) Clinical Material.
Recall #B-262/268-9.

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

MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, California.

RECALLED BY
Manufacturer, by fax on November 2, 1997, and by letter on November 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 42 lots; b) 28 lots; c) 51 lots; d) 36 lots; e) 3 lots; f) 2 lots; g) 15 lots.

REASON
Intravenous drug products, produced under conditions whereby they may have become contaminated with fungi, mold, or other microorganisms, or may contain particulate matter.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis. Recall #B-283/285-9.

CODE
Unit numbers: a) 04G90086; b) 04LE06090, 04G90086, 04J93337; c) 04LP34525, 04FP42647, 04P38812.

MANUFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by telephone on August 7, 1998, and by letter dated August 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maine, Massachusetts, Vermont, West Virginia.

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

REASON
Blood products were mislabeled as CMV antibody negative.

________
PRODUCT
Platelets, Pheresis. Recall #B-287-9.

CODE
04P37504A, 04LP31767B, 04P37605A, 04LP31913A, 04LP31913B, 04LR31740B, 04LP31990A, 04LP31756B, 04LP31990B, 04LP31756A, 04LP31999A, 04FP40395A, 04LP31999B, 04FP40395B, 04LP32000A, 04LP31849A, 04LP31849B, 04LP32000B.

MANUFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by letters dated February 13 and 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
18 units were distributed

REASON
Blood products had unacceptable platelet counts.

________
PRODUCT
Red Blood Cells. Recall #B-304-9.

CODE
Unit #8003751.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated September 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

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. Recall #B-305-9.

CODE
Unit #8022949.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, 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 use of the drug Proscar after donation.

________
PRODUCT
Fresh Frozen Plasma. Recall #B-308-9.

CODE
Unit #8021128.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by telephone on June 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit was distributed.

REASON
Blood product was incorrectly labeled with the wrong ABO typing.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
Bremer brand Adjustable Ring used in the Halo Traction Set (classification name is "Skull Tongs", intended to provide stability to the cervical spine to aid in healing: a) Catalog #HT001; b) Caalog #HT002. Recall #Z-185/186-9.

CODE
Lot numbers: 26468, 26745, 26934, 27095, 27267, 28092, 28761, 27099, 27243, 28007, 28758, 28976 and 29039.

MANUFACTURER
Bremer Medical, Inc., Jacksonville, Florida.

RECALLED BY
Manufacturer, by letter mailed or faxed on October 25, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
253 adjustable rings were distributed.

REASON
Inadequate threads in the holes may strip and result in loose fit when adjustment bolts are tightened.

________
PRODUCT
Philips Bucky Diagnost TS-X-Ray System. Recall #Z-211-9.

CODE
Model 9848-600-00171, Serial numbers: 9801017, 9801085, 9801049, 9700009, 9000070, 38506, 38556, 9701086.

MANUFACTURER
Philips Medical Systems, Shelton, Connecticut.

RECALLED BY
Manufacturer. FDA approved the firm's corrective Action plan on December 1, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
8 units were distributed.

REASON
Noncompliance with performance standards for x-ray products in that the type number 9848-600-00171 uncertified beam limiting device was installed in the device.

________
PRODUCT
VICOM Central Station Monitor Software Program: a) Product Code No. 056030; b) Product Code No. 056530; c) Datascope Visa II. Recall #Z-225/227-9.

CODE
All Software Version 8.01.26 and Version 1.00.05

MANUFACTURER
Vitalcom, Inc., Tustin, California.

RECALLED BY
Manufacturer, by letter on September 25, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Arizona, California, Indiana, Kansas, Louisiana, Michigan, Missouri, New Jersey, Oregon, Pennsylvania, Utah, Virginia, District of Columbia.

QUANTITY
82 Version 8.01.26 and 7 Version 1.00.05 software programs were distributed.

REASON
When the system is placed into certain modes some arrhythmias and other events may not be detected due to software error.

________
PRODUCT
Punctur-Guard(tm) Blood Collection Needle. Recall #Z-247/249-9.

CODE
Puncture-Guard Blood Collection Needles: a) Catalog #4214- 21, Ga x 1.5; b) Catalog #4212-21, Ga x 1; c) Catalog #4222-22, Ga x 1. Recall #Z-247/249-9.

CODE
Product manufactured from 10/10/96-12/1/97 with a 5 year Expiration Date. Various Master and Manufacturing Lots.

MANUFACTURER
Bio-plexus, Inc., Vernon, Connecticut.

RECALLED BY
Manufacturer, by letter on November 18, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
9,694,278 units were distributed.

REASON
Bunting mechanism may not function as intended throughout labeled shelf life.

________
PRODUCT
Heartport Endovenous Drainage Cannula, indicated for use in patients undergoing cardiac surgery requiring cardiopulmonary bypass. Recall #Z-253-9.

CODE
All lot numbers.

MANUFACTURER
Heartport, Inc., Redwood City, California.

RECALLED BY
Manufacturer, by fax on September 2, 1998, followed by visit. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
7,122 units were distributed.

REASON
The products sterility barrier may become compromised to tears in the Mylar.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Impla-Med Titanium, Hex Cylinder Implant Devices: Catalog numbers: a) 901201, ; b) 901204 c) 901207; d) 901210; e) 901213; f) 901216; g) 901219; h) 901222; i) 901225; j) 901228; k) 901231; l) 901232; m) 901234; n) 901237; o) 901240; p) 901243, q) 901246. Recall #Z-230\246-9.

CODE

 
Product manufactured: 4/27/98-10/20/98 . Serial numbers as listed 
below:
a) HCHO8x3.3 CYL 8X3.3 HA W/HCS, Lot numbers:   4610/1562-0604, 
4610/3282-0501, 4610/3337-0404, 4610/5238-0602;
b) HCHO8x4.0 CYL 8X4.0 HA W/HCS, Lot numbers:  1825/3337-0404,
1825/5308-0701, 3124/5308-0704;
c) HCH10x3.3 CYL 1OX3.3 HA W/HCS, Lot numbers:  3665/3282-0601,
3665/3337-0404, 3665/5308-0702, 4611/1562-0604, 5642/1562-0702, 
5642/5177-0704, 5642/5600-0704;
d) HCH 10x4.0 CYL 1OX4.0 HA W/HCS, Lot numbers:  1827/3337-0701, 
1827/3337-0704, 2100/1562-0704, 2684/1562-0704, 4496/3337-0404,
4496/5238-0601, 4496/5238-0602, 5699/5703-0704, 
e) HCH 13X3.3 CYL 13X3.3 HA W/HCS, Lot numbers:  1937/3337-0404,
1937/5238-0601, 1937/5238-0602;
f) HCH 13x4.0 CYL 13x4.0 HA W/HCS, Lot numbers: 1826/1985-0404, 
1826/5686-0704, 3552/5686-0704, 4394/5343-0704, 5194/3282-0503,
5194/5238-0601;
g) HCH 15x3.3 CYL 15X3.3 HA HCS, Lot numbers:  3722/5238-0601,
3722/5238-0602, 4354/1985-0404, 4354/5238-0601, 4354/5703-0704, 
h) HCH l5x4.0 CYL 15X4.0 HA W/HCS, Lot numbers:  5532/3337-0404,
5532/5238-0601;
i) HCT O8x3.3 CYL 8X3.3 TPS W/HCS, Lot numbers:  3707/5600-0704,
4607/1985-0702, 4607/3337-0404, 4607/5238-0601, 4607/5238-0602;
j) HGT08x4.0 CYL 8X4.0 TPS W/HCS, Lot numbers:  1487/1513-0704, 
3718/3337-0404, 4620/1513-0704, 4620/3337-0701, 4620/3337-0704;
k) HCTI0x3.3 CYL 1OX3.3 TPS W/HCS, Lot numbers:  4498/3337-0404,
4498/5238-0601, 4498/5238-0602, 4925/5238-O601, 4925/5308-0702,
5535/5420-0704,
l) HCT10X3,3cyl 10X3.3 TPS W/SCS, Lot #4498/5312-0601;
m) HCT10x4.0 CYL 10x4.0 TPS W/HCS, Lot numbers:  4493/3337-0404, 
4493/5238-0601, 4493/5238-0602;
n) HCT 13x3.3 CYL 13X3.3 TPS W/HCS, Lot numbers:  4494/5238-0601, 
4495/3337-0404, 4495/5238-0601, 4672/5304-0702, 4998/5420-0704, 
5539/5547-0704;
o) HCT 13x4.0 CYL 13X4.0 TPS W/HCS, Lot numbers:  3744/5267-0704,
4491/3337-0701, 4497/3337-0404, 4497/5238-0601, 4497/5238-0602,
4670/5177-0704, 5538/5547-0704;
p) HCT15x3.3 CYL 15X3.3 TPSW/HCS, Lot numbers:  4608/1986-0702,
4608/3337-0404, 4608/5238-0601, 4608/5308-0702, 4999/5177-0704, 
4999/5600-0801, 5542/1562-0801, 5542/5600-0801;
q) HCT15x4.0 CYL 15X4.0 TPS W/HCS, Lot numbers:  3736/5177-0704,
5291/5238-0702, 5544/1985-0404, 5544/3337-0701.

MANUFACTURER
Steingold/Implamed, Attelboro, Massachusetts.

RECALLED BY
Sterngold/Implamed, Attelboro, Massachusetts, by letter dated November 13, 1998, and by fax on November 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
Pennsylvania, Florida, New York, Missouri, Maryland, Virginia, international.

QUANTITY
512 units were distributed.

REASON
Fragments of the sterile plastic holder a component used to package the Hex Cylinder Implants may detach (fragment) from the holder before or during placement.

________
PRODUCT
System 1000 and TINA Single Patient Hemodialysis Delivery Systems with Double Pump Single Needle (DPSND) Option and/or Hemavision Options, used to provide hemodialysis treatments in the acute and chronic setting, including high flux dialysis. Recall #Z-254-9.

CODE
There are 708 different, out of sequence serial numbers involved.

MANUFACTURER
Althin Medical, Inc., Miami Lakes, Florida and Althin Medical AB-Ronneby, Ronneby, Sweden.

RECALLED BY
Althin Medical, Inc., Miami Lakes, Florida, by letters on November 2 and 8, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
International.

QUANTITY
704 devices were distributed.

REASON
Software error which may cause the Arterial/Venous pressure limits to open and remain open.

END OF ENFORCEMENT REPORT FOR DECEMBER 16, 1998. ####