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.
ENFORCE
10/04/1995
ENFORCEMENT REPORT FOR 10/4/95
October 4, 1995 95-40
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Refrigerated and Frozen Unpasteurized Orange Juice, in 8
ounce, 32 ounce, 64 ounce, one gallon, and 5 gallon pails
(for refrigerated product) and in 87 ounce plastic jugs (for
the frozen product). Recall #F-819-5.
CODE All unexpired refrigerated product which at this point is
"USE BY 8/17" and USE BY 8/20" and also one shipment of
frozen unpasteurized product with code ENENN.
MANUFACTURER Florida's Own Juice Company, Winter Haven, Florida.
RECALLED BY Manufacturer, by letter August 15, 1995, and by press
release issued August 16, 1995. Firm-initiated recall
complete.
DISTRIBUTION Tennessee, Massachusetts, Maryland, Nebraska, Illinois,
Georgia, Florida.
QUANTITY Firm estimated that 3,495 gallons remained on market at time
of recall initiation.
REASON The product was implicated in a May 1995 outbreak of
Salmonella food poisoning in Orlando, Florida, in which
Salmonella hartford and/or Salmonella gaminara were isolated
from 63 patients. CDC isolated Salmonella gaminara from
samples of the product. The product was presumably
contaminated with Salmonella gaminara and/or Salmonella
hartford.
_______________
PRODUCT Martha White Chewy Fudge Brownie Mix, net weight 21.6
ounces. Recall #F-820-5.
CODE Lot #G5S16C8.
MANUFACTURER Gilster Mary Lee, Steelville, Illinois.
RECALLED BY The Pillsbury Company, Minneapolis, Minnesota, by electronic
mail notice, and by press release dated August 24, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Tennessee, Texas.
QUANTITY 216 cases (12 per case) were distributed.
REASON Product contains undeclared walnuts.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Strawberry Cheesecake Homemade Fudge, packaged industry
standard plastic containers, 8 ounces. Recall F-821-5.
CODE Best if eaten by 9/95; Best if eaten by 10/95; Best if eaten
by 11/1/95-11/19/95.
MANUFACTURER Nancy's Homemade Fudge, Inc., Meadows of Dan, Virginia.
RECALLED BY Manufacturer, by telephone on or about August 3, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Tennessee, Virginia, North Carolina, Pennsylvania,
Kentucky, Alabama, Delaware.
QUANTITY 1,419 units were distributed.
REASON The product contains Undeclared FD&C Yellow No. 5.
_______________
PRODUCT Campbell's Chunky Ready to Serve Soup New England Clam
Chowder, in 10-3/4 ounce cans. Recall #F-822-5.
CODE Can - DEC 96 CH4 CS B8DF with any hour code (last 4
numbers);
Case - 10885 08 DEC 96.
MANUFACTURER Campbell Soup Company, Inc., Sacramento, California.
RECALLED BY Campbell Soup Company, Camden, New Jersey, by visit and by
letter sent April 26, 1995 Firm-initiated recall complete.
DISTRIBUTION Alaska, Arizona, Colorado, California, Idaho, Montana,
Nevada, Oregon, Utah, Washington, Hawaii, Japan.
QUANTITY 158,700 cans were distributed; firm estimated that 5,000
cans remained on market at time of recall initiation.
REASON Product was contaminated with glass pieces.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Foodtown Sliced Beets, in 14.5 ounce cans.
Recall #F-716-5.
CODE 1 KERN 82844.
MANUFACTURER Comstock Michigan Fruit Division C, Leicester, New York.
RECALLED BY Twin County Grocers, Inc., Edison, New Jersey, by letter
November 17, 1994. Firm-initiated recall complete.
-2- DISTRIBUTION New York and New Jersey.
QUANTITY Approximately 20 cases were distributed; firm estimates none
remains on the market.
REASON Product is labeled and sold as corn but it is actually
sliced beets.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Neosar, Cyclophosphamide for Injection, USP, 500 mg, anti-
neoplastic, under the Pharmacia or Abbott labels.
Recall #D-249-5.
CODE Lot #APC015 (Pharmacia) or 82005T4 (Abbott).
MANUFACTURER ASTA Medica AG, Kunsebeck, Germany.
RECALLED BY Pharmacia, Inc., Columbus, Ohio, by letter September 21,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 42,744 vials were distributed; firm estimated that very
little product remained on market at time of recall
initiation.
REASON Stability testing disclosed potential for subpotency.
_______________
PRODUCT Guaifenesin 600 mg and Pseudoephedrine HCl 120 mg Tablets,
in bottles of 100, Rx combination, expectorant and
decongestant, under the URL label. Recall #D-250-5.
CODE Lot numbers: L2694254 EXP 3/97, L2694255 EXP 3/97, D1695049
EXP 5/97.
MANUFACTURER Lini, Inc., Rahway, New Jersey.
RECALLED BY Manufacturer, by letter June 20, 1995. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimated that 5,206 remained on market at time of
recall initiation.
REASON Some labels have a typographical error in the dosage
statement.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT UltraTag RBC Kit for the preparation of Technetium Tc 99m-
Labeled Red Blood Cells, Rx in-vivo diagnostic.
Recall #D-251-5.
CODE NO68-5020 NO68-5021 NO68-5023 NO68-5024
NO68-5025 NO68-5026 NO68-5027 NO68-5028
NO68-5029 NO68-5030.
These lot numbers represent the lot number on the kit. Each
of the components bears their own lot numbers..
MANUFACTURER Mallinckrodt Medical, Inc., Maryland Heights, Missouri.
RECALLED BY Manufacturer, by telephone August 15-16, 1995, followed by
letter dated August 15, 1995. Firm-initiated field
correction ongoing.
-3- DISTRIBUTION Nationwide.
QUANTITY 6,571 kits were distributed.
REASON The reaction vial component incorrectly declares potency as
milligram instead of microgram. Other labeling is correct.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-623/624-5.
CODE Unit #31KE11728.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by letter dated May 10, 1995. Firm-initiated
recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who had
admitted to visiting an area designated as endemic for
malaria, were distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Recovered Plasma.
Recall #B-634/636-5.
CODE Unit numbers: (a) LZ89150, LZ89163; (b) LZ89156, LZ89164;
(c) LZ89153, LZ89156, LZ89157, LZ89160, LZ89161, LZ89162,
LZ89164, LZ89166.
MANUFACTURER Cooley Dickinson Hospital, Northhampton, Massachusetts.
RECALLED BY Manufacturer, by letters dated June 22, 1995. Firm-
initiated recall complete.
DISTRIBUTION Massachusetts, Pennsylvania.
QUANTITY (a) 2 units; (b) 2 units; (c) 8 units.
REASON Blood products, which were incorrectly tested for antibody
to the human immunodeficiency virus types 1 and 2 (anti-HIV-
1/2), were distributed.
_______________
PRODUCT5 (a) Red Blood Cells; (b) Platelets;
(c) Platelets, Pheresis; (d) Granulocytes/Platelets,
Pheresis; (e) Source Leukocytes; (f) Recovered Plasma.
Recall #B-638/643-5.
CODE Unit numbers: (a) O1Y06338, 01Y06845; (b) O1P11004,
O1P11823, 01P11937, 01P12830, 01P12940, 01P13105, 01P13786,
01P15068, 01P15126, 01Y06338, 01YO6845; (c) 01P08059,
01P09525, 01P09952, 01P10357, 01P10432, 01P10552, 01P10618,
01P10698, 01P10832, 01P10905, 01P11161, 01P11243, 01P11340,
01P11541, 01P11745, 01P13048, 01P13593, 01P15507; (d)
01P08059, 01P08895, 01P12754, 01P13466; (e) 01P09952,
01P10357, 01P10382; (f) 01P10905, 01P11161, 01P11243,
01Y06338, 01Y06845.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
RECALLED BY Manufacturer, by letters issued in October and November
1994. Firm-initiated recall complete.
DISTRIBUTION California and New York.
-4- QUANTITY (a) 2 units; (b) 11 units; (c) 18 units; (d) 4 units; (e) 2
units; (f) 5 units.
REASON Blood products, which tested initially reactive for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1), and were not retested in duplicate, or were
collected from a donor who previously tested initially
reactive for anti-HIV-1 and was not retested in duplicate,
were distributed.
_______________
PRODUCT Source Plasma. Recall #B-644-5.
CODE PA78959, XA41032, XA46811, PA18487, PA18635, PA91867,
PA26688, PA26918, PA31011, PA36820, PA37458, PA37812,
PA39888, PA42405, PA42762, PA47526, PA50156, XA66491,
PA88169, PA88295, PA89302, PA60751, PA60936, PA61151,
PA61384, PA68310, PA68409, PA68517, XA68684, XA71514,
XA71903, XA72001, XA72163, XA72288, XA72402, XA72511,
XA72657, XA72753, XA72902, XA72993, PA72191, PA72360,
PA72717, PA72932, XA76151, XA43586, XA58322, XA69191,
XA69341, XA72349, XA78909, XA60765, XA28308, XA38861,
XA17486, XA17930, XA17701, XA18102, XA18843, XA19308,
XA20279, XA20539, XA30130, XA30875, XA59418, XA60081,
XA61275, XA61638, XA62230, XA62680, XA63070, XA63596,
XA64297, XA64457, XA64766, XA65496, XA65821, XA66994.
MANUFACTURER Community Bio-Resources, Inc., Birmingham, Alabama.
RECALLED BY Manufacturer, by letters dated July 22, 1994, and August 11,
1994. Firm-initiated recall complete.
DISTRIBUTION New York, Puerto Rico, Austria.
QUANTITY 78 units.
REASON Source Plasma which: tested negative for antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but was
collected from donors who previously tested repeatedly
reactive for anti-HIV-1; tested negative for hepatitis B
surface antigen (HBsAg), but was collected from donors who
previously tested repeatedly reactive for HBsAg or had a
history of hepatitis; or was collected from donors with a
history of intravenous (IV) drug use/high risk behavior was
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-637-5.
CODE Unit numbers: LZ89149, LZ89151, LZ89152, LZ89154, LZ89155,
LZ89159, LZ89165.
MANUFACTURER Cooley Dickinson Hospital, Northhampton, Massachusetts.
RECALLED BY Manufacturer, by letters dated June 22, 1995. Firm-
initiated recall complete.
DISTRIBUTION Massachusetts, Pennsylvania.
QUANTITY 7 units.
REASON Blood products, which were incorrectly tested for antibody
to the human immunodeficiency virus types 1 and 2 (anti-HIV-
1/2), were distributed.
-5- _______________
PRODUCT Antihemophilic Factor (Recombinant) Recombinate(TM).
Recall #B-633-5.
CODE Lot numbers: 2938A112AA, 2938A115AA, 2938A117AA,
2938A123AA, 2938A125AA, 2938C005AC, 2938C009AA, 2938C010AA,
2938C014AC, 2938C015AE, 2938C016AB, 2938C017AB, 2938C019AA,
2938C019AB, 2938C020AA, 2938C020AB, 2938C021AA, 2938C022AA,
2938C025AA, 2938C026AA, 2938C027AA, 2938C028AA, 2938C029AA,
2938C029AB, 2938C032AA, 2938C033AA, 2938C034AA, 2938C035AA,
2938C036AB, 2938C037AA, 2938C038AA, 2938C039AB, 2938C039AC,
2938C045AA, 2938C046AA.
MANUFACTURER Baxter Healthcare Corporation, Glendale, California.
RECALLED BY Manufacturer, by letters dated February 3, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 178,676 kits.
REASON Product vials, which contain a transfer needle that can core
the rubber stopper, causing fragments to fall into the
vials, were distributed.
_______________
PRODUCT Platelets. Recall #B-645-5.
CODE Unit numbers: 31KV15232, 31KY07297, 31KY07300, 31KY07313,
31KY07319, 31KY07306, 31KY07305, 31KY07296, 31KE15407,
31KE15396, 31KC15120, 31KT14795, 31KW11003, 31KW10998,
31KE15416, 31KW11005, 31KW11007, 31KT14788, 31KS13194,
31KC15117, 31KV15231, 31KV15235, 31KV15223, 31KV15238,
31KS13204, 31KS13203, 31KV15247, 31KV15245, 31KE15408,
31KY07299, 31KV15240, 31KV15241, 31KY07314, 31KY07310,
31KS13206, 31KS13207, 31KC15115, 31KS13202, 31KF05088,
31KF05090, 31KT14778, 31KV15277, 31KV15279, 31KV15281,
31KC15118, 31KV15249, 31KF05095, 31KV15258, 31KV15269,
31KF05093, 31KS13198, 31KF05081, 31KT14781, 31KC15119,
31KV15226, 31KV15262, 31KF05087, 31KW10996, 31KS13199,
31KF05085, 31KT14797, 31KC15109, 31KT14784, 31KV15275,
31KV15266, 31KY07309, 31KY07315, 31KY07318, 31KY07311,
31KY07298, 31KY07303, 31KV15244, 31KV15222, 31KV15234,
31KY07301, 31KC15114, 31KV15264, 31KF05092, 31KC15116,
31KT14790.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by telephone June 8, 1995, followed by letter
dated June 12, 1995. Firm-initiated recall complete.
DISTRIBUTION New York, Pennsylvania.
QUANTITY 80 units.
REASON Blood products, which were exposed to unacceptable storage
temperatures, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Tomoscan SR 7000 Computed Tomography System with software
version 1.1C, for CT applications. Recall #Z-1090-5.
CODE All codes.
-6- MANUFACTURER Philips Medical Systems Nederlands, Best Nederlands.
RECALLED BY Philips Medical Systems North America Company, Shelton,
Connecticut. Firm-initiated field correction completed
under FCO 14 403 014 dated November 1993.
DISTRIBUTION Nationwide and Canada.
QUANTITY 9 units were subject to field correction.
REASON Noncompliance with performance standard for x-ray diagnostic
products in that improper software validation during the
manufacture of the version 1.1C produced software which
would accept an incorrect start position and improperly scan
patients.
_______________
PRODUCT Sportrol Combination Spore Strip Biological Indicators,
containing Bacillus stearothermophilus and Bacillus subtilus
var. niger spores for monitoring sterilization processes.
Recall #Z-1206-5.
CODE Lot numbers: X693, X695, X697, X698.
MANUFACTURER North American Science Associates, Inc., (NAmSA), Northwood,
Ohio.
RECALLED BY Manufacturer, by letters dated June 29, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 22,100 strips were distributed.
REASON Stability testing confirmed reduced resistance to
sterilization temperatures.
_______________
PRODUCT Electrode Lead Wires. Recall #Z-1207-5.
CODE All lead wires with unprotected (exposed pin style)
electrode lead wires.
MANUFACTURER Lead-Lok, Inc., Sandpoint, Idaho.
RECALLED BY Manufacturer, by letter June 7, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product labeling fails to provide adequate directions for
use and devices pose an unwarranted risk of injury to
patients, because the products are not labeled to
contraindicate use with apnea monitors.
_______________
PRODUCT Coated Vicryl (polyglactin 910) Absorbable Sterile Sutures,
packaged by B.E.C. Medical Products into four types of kits:
(a) Lap-Chole-Pak; (b) C-Section Pak; (c) C.A.B.G. Custom
Pak; (d) Laparoscopy Pak. Recall #Z-1209/1212-5.
CODE B.E.C. Medical products lot nos: 306336, 306192, 306268,
306104, 306122, 306450; Ethicon codes: GD9097, GD9511,
GC9993, GD9471, GD9794, GD9101, GC2446.
MANUFACTURER Ethicon, Inc., San Antonio, Texas.
RECALLED BY B.E.C. Medical Products, Toledo, Ohio, by fax September 16-
29, 1994, followed by telephone. Firm-initiated recall
complete.
-7- DISTRIBUTION Georgia, Michigan, Ohio, Texas.
QUANTITY 370 kits were distributed; firm estimates none remains on
market.
REASON The sterility of the sutures contained in these devices
cannot be assured because of possible microorganism
contamination during aseptic processing, following
sterilization.
_______________
PRODUCT LAPRO-CLIP Absorbable Ligating Clip:
(a) Product Code 8487-08; (b) Product Code 8487-12;
(c) Product Code 8487-13; (d) Product Code 8487-82.
Recall #Z-1216/1219-5.
CODE All lots distributed from 11/93.
MANUFACTURER Davis & Geck, Inc., Danbury, Connecticut.
RECALLED BY Manufacturer, by letter August 3, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 10,781 boxes were distributed.
REASON Device's foil moisture barrier may be punctured resulting in
exposure of the devices to moisture, thereby compromising
their sterility.
_______________
PRODUCT INVOS 3100 Cerebral Oximeter and associated SomaSensors.
Cerebral Oximeter, is a monitor which when connected to a
sensor device, is intended to non-invasively measure the
approximate regional oxygen saturation (rS02) of the
hemoglobin in the microvasculature of an adult's brain.
Recall #Z-1230/1231-5.
CODE All serial numbers.
MANUFACTURER Somanetics Corporation, Troy, Michigan.
RECALLED BY Manufacturer, by letters of January 28, 1994 and February 1,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Michigan, Minnesota, Missouri,
Nebraska, New Jersey, New York, Ohio, Utah, Virginia,
Wisconsin, Connecticut, Illinois, Kentucky, Massachusetts,
New Mexico, Texas, Canada.
QUANTITY Approximately 122 INVOS 3100 Cerebral Oximeter units and
approximately 369 of the associated sensors remained on
market at time of recall initiation.
REASON Premarket notification (510(k)) was rescinded based on
CDRH's determination that the data supporting the 510(k)
were incomplete.
_______________
PRODUCT Cordis brand Percutaneous Entry Trays, used for procedures
requiring catheter introduction. Recall #Z-1232/1236-5.
CODE Catalog Number Lot Numbers
501-636U 30495608, 30595604
501-637U 30495609
501-638U 30495606, 30495610, 30595602,
30595603
-8- Catalog Number Lot Numbers
501-601U 30495605, 30595600
501-648U 30495607, 30495611.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
RECALLED BY Manufacturer, by letter dated June 23, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Latin America.
QUANTITY 1,000 units were distributed.
REASON The sterility may become compromised due to the package
seals opening.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Actin Activated FSL Activated PTT Reagent, for use in the
determination of the activated partial thromboplastin time
and related coagulation procedures. Recall Z-1170-5.
CODE Catalog #B4219-2, Lot #FSL-103 EXP 5/27/96.
MANUFACTURER Dade International of Puerto Rico, Aguada, Puerto Rico.
RECALLED BY Dade International, Inc., Miami, Florida, by letter dated
July 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 2,948 units were distributed.
REASON This lot may exhibit vial to vial variability resulting in
prolonged activated partial thromboplastin times (APTTS).
_______________
PRODUCT Diamedix Fluid Sampler Handler (FSH), a fully programmable
fluid handling system capable of precise liquid sampling and
preparation. Recall #Z-1237-5.
CODE All codes.
MANUFACTURER Hyperion, Inc., Miami, Florida.
RECALLED BY Diamedix Corporation, Miami, Florida, by letters of June 1
and 20, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 299 units were distributed.
REASON The performance of the FSH with automated testing equipment
can cause unreliable test results.
-9-
END OF ENFORCEMENT REPORT FOR OCTOBER 4, 1995. BLANK PAGES MAY
FOLLOW.
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