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.

May 6, 1998 98-18

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Queso Fresco Cheese under the following labels,
"El Tapatio", 5 ounce and 15 ounce wheels; "El
Caporal", 5 ounce and 10 ounce wheels; "La
Banderita",15 ounce wheels; and "La Vaca Rica", 12
ounce, 20 ounce, 1.33 pound and 2.25 pound sizes.
Recall #F-474-8.
CODE All with sell by dates through July 14, 1998.
MANUFACTURER Specialty Cheese Company, Lebanon, Wisconsin.
RECALLED BY La Hispamex Food Products, Inc., Cicero, Illinois
(repacker), by telephone on March 20, 1998,
followed by fax and visit. Ongoing recall
resulted from sample analysis and follow-up by the
North Carolina Department of Agriculture and
Consumer Services and the Illinois Department of
Public Health.
DISTRIBUTION Nationwide.
QUANTITY 248,938 pounds were distributed; firm estimated
that 30 percent of the cheese remained on market
at time of recall initiation.
REASON Product is contaminated with Listeria
monocytogenes.

_______________
PRODUCT Casa Visco brand Italian Style Giardinera, a
pickled vegetable medley, in 16 ounce and 32 ounce
glass jars. Recall #F-479-8.
CODE All codes labeled as "Italian Style".
MANUFACTURER Cosmo's Food Products, Inc., West Haven,
Connecticut.
RECALLED BY Viscusi Wholesale Grocers, Inc., Schenectady, New
York, by memorandum dated March 30, 1998, and by
press release on March 31, 1998. Completed recall
resulted from sample analysis and follow-up by the
New York State Department of Agriculture and
Markets.
DISTRIBUTION New York, New Jersey, Pennsylvania, Massachusetts,
Vermont, Connecticut, New Hampshire.
QUANTITY Undetermined.
REASON Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Red Cheek 100% Apple Juice from Concentrate, in 64
fluid ounce plastic containers.
Recall #F-473-8.
CODE M 70725, M 70728, M 70729, M 70730.
MANUFACTURER Mayer Brothers Apple Products, Baker, New York.
RECALLED BY Mott's North America, Stamford, Connecticut, by
fax letter on October 14, 1997, followed by visit.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maryland, Vermont, Pennsylvania.
QUANTITY 21,136 cases were distributed.
REASON Product is unfit for food due to off-odor/off-taste.

_______________
PRODUCT Ocean Beauty brand Frozen yellowfin Tuna Steaks,
in 10 pound cases. Recall #F-477-8.
CODE S0268D.
MANUFACTURER Ocean Beauty Seafoods, Inc., Seattle, Washington.
RECALLED BY Ocean Beauty Seafoods, Inc., Seattle, Washington,
by telephone on March 27, 1998. Firm-initiated
recall complete.
DISTRIBUTION California, Oregon, Pennsylvania, Texas.
QUANTITY 125 cases were distributed; firm estimated that 66
cases remained on market at time of recall
initiation.
REASON Product is decomposed.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT Eye Cream in 1 fluid ounce tubes distributed under
Cosmetic Specialty Labs., Inc. (CSLI) and Aularale
labels as follows:
a) Eye Cream, product number 1019,
b) Aularale Eye Nourishing Cream, product number
2481021. Recall #F-475/476-8.
CODE a) 890-4; b) 1234567890-6.
MANUFACTURER Cosmetic Specialty Labs., Inc., Lawton, Oklahoma.
RECALLED BY Manufacturer, by letters dated July 28, 1997, and
March 25, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arkansas, Florida, Georgia, Illinois,
Indiana, Massachusetts, Maryland, Nevada,
Oklahoma.
QUANTITY 332 tubes of the CSLI label and 356 tubes of the
Aularale label were distributed.
REASON Products may be contaminated with Paecilomyces
variotii.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Decadron Phosphate Injection (Dexamethasone Sodium
Phosphate), 4 mg per mL in 1 mL and 2 mL vials, in
boxes of 25 units, indicated for the treatment of
multiple disorders, diseases or medical states.
NDC # 0006-7628-66. Recall #D-118-8.
CODE LOT NUMBERS: 1ml vials: Lots #'s 0307E (EXP.
1/00) and 0909E (EXP. 1/00)
2ml vials (distributed only internationally):
Lot 0301B(EXP 3/98) Lot 0734B(EXP 5/98)
Lot 0772B(EXP 7/98) Lot 0451E(EXP 6/99)
Lot 1086D(EXP 6/99) Lot 1087D(EXP 6/99)
Lot 0237B(EXP 2/98) Lot 0238B(EXP 2/98)
Lot 1137D(EXP 6/99) Lot 0450E(EXP 7/99)
Lot 0435E(EXP 8/99) Lot 0446E(EXP 3/00)
Lot 0448E(EXP 3/00) Lot 0617E(EXP 4/00)
Lot 1096E(EXP 9/00).
MANUFACTURER Merck Manufacturing Division, Division of Merck &
Company, Inc., West Point, Pennsylvania.
RECALLED BY Manufacturer, by letter on January 21, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 2,500 1-ml vials and an undetermined
amount of 2-ml vials remained on market at time of
recall initiation.
REASON Precipitate/degradation.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Fluocinonide Topical Solution USP, 0.05%, in 60 ml
bottles, Rx for the relief of the inflammatory and
pruritic manifestations of corticosteroid
responsive dermatoses, under the Lemmon and Major
labels. NDC #0093-0266-39 and #0904-0769-03.
Recall #D-119-8.
CODE Lot numbers: 6525 EXP 5/98, 6622 EXP 5/98.
MANUFACTURER TEVA Pharmaceuticals USA, Inc., Sellersville,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated January 28, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 500 bottles of lot 6525 under the Major label and
15,457 bottles under the Lemmon label and 15,963
bottles of lot 6622 under the Lemmon label were
distributed.
REASON Degradation/impurities leading to subpotency.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-767-8.
CODE Unit 81-13308.
MANUFACTURER Michigan Community Blood Centers, Traverse City,
Michigan.
RECALLED BY Manufacturer, by telephone on June 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with
Graves disease.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma, Frozen. Recall #B-876/878-8.
CODE Unit numbers: a) 39F58065, 39F56749, 39G70442
b) 39F58065, 39F56749
c) 39F58065, 39F56749, 39G70442.
MANUFACTURER American Red Cross Tri-State Region, Huntington,
West Virginia.
RECALLED BY Manufacturer, by letter dated February 18, 1998.
Firm-initiated recall complete.
DISTRIBUTION California, Kentucky, Ohio, West Virginia.
QUANTITY a) 3 units; b) 2 units; c) 3 units were
distributed.
REASON Blood products were collected from a donor with a
history of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-918-8.
CODE Unit #10529-8245.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on August 21, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
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 Fresh Frozen Plasma. Recall #B-919-8.
CODE Unit #10534-4577.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on August 23, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of clotted
red blood cells.

_______________
PRODUCT Red Blood Cells. Recall #B-929-8.
CODE Unit #22FT82854.
MANUFACTURER American Red Cross Blood Services, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on September 2, 1997,
and by letters dated September 9 and 15, 1997.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was incorrectly tested for anti-CMV
was distributed for transfusion.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-952/953-8.
CODE Unit numbers: a) 34-33611, 34-34338, 34-36637,
34-37480; b) 34-33611, 34-34338, 34-36637.
MANUFACTURER Michigan Community Blood Centers, Saginaw,
Michigan.
RECALLED BY Manufacturer, by letter on December 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan and Mississippi.
QUANTITY a) 4 units; b) 3 units were distributed.
REASON Blood products were collected from a donor with
Graves disease.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-954/955-8.
CODE Unit numbers: a) 34-33722, 34-34415, 34-35177,
34-35890, 34-36594, 34-37284
b) 34-33722, 34-34415, 34-35177, 34-35890,
34-36594.
MANUFACTURER Michigan Community Blood Centers, Saginaw,
Michigan.
RECALLED BY Manufacturer, by letter on October 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY a) 6 units; b) 5 units were distributed.
REASON Blood products were collected from a donor with
Graves disease.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma;
c) Red Blood Cells for further manufacture
d) Recovered Plasma. Recall #B-961/964-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Galesburg,
Illinois.
RECALLED BY American Red Cross Blood Services, Peoria,
Illinois, by letters dated September 1, 1997,
October 1, 1997, February 5, 1998 or March 10,
1998, and October 24, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois, Iowa, Michigan, Massachusetts,
Mississippi, California, Switzerland.
QUANTITY a) 19 units; b) 1 unit; c) 2 units; d) 20 units
were distributed.
REASON Blood products tested negative for the antibody to
the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor who
previously tested initially reactive for
anti-HIV-1, with no duplicate retesting.

_______________
PRODUCT a) Whole Blood; b) Red Blood Cells
c) Platelets; d) Plasma
e) Source Leukocytes
f) Platelets, for further manufacturing
g) Recovered Plasma. Recall #B-970/976-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by telephone on January 16, 1998, or
by letter dated January 12 or 29, 1998, by fax on
February 18, 1998, and March 11, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Pennsylvania, District of Columbia,
Massachusetts, New Jersey, California.
QUANTITY a) 1 unit; b) 36 units; c) 23 units; d) 8 units;
e) 8 units; f) 2 units; g) 27 units were
distributed.
REASON Blood products tested negative for the antibody to
the human immunodeficiency virus type 1
(anti-HIV-1), but were collected from a donor who
previously tested repeatedly reactive for
anti-HIV-1, Western blot negative.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma, for further manufacture.
Recall #B-994/996-8.
CODE Unit #11N25297.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on March 25, 1997, and
on April 2, 1997. Firm-initiated recall complete.
DISTRIBUTION Missouri, Alabama, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose
spouse has hepatitis C.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-997/998-8.
CODE Unit 11H70853.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on October 9 and 14,
1997. Firm-initiated recall complete.
DISTRIBUTION Missouri and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had
been deferred for high risk behavior.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c)
Cryoprecipitate; d) Plasma; e) Fresh Frozen
Plasma; f) Whole Blood; g) Recovered Plasma.
Recall #B-1001/1007-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by telephone on November 17, 1996,
and by letters on one of the following dates:
1/15/97, 1/27/97, 1/30/97, 2/4/97, 2/10/97,
2/11/97, 2/12/97, 2/19/97, 2/20/97, 2/21/97,
2/24/97, 2/27/97, 2/29/97, 4/2/97. 4/14/97,
4/23/97, 7/9/97, or 7/24/97. Twenty seven
non-responding consignees were sent second recall
notices on either 3/17/97, 3/18/97, 3/19/97,
4/25/97, 5/27/97, 6/2/97 or 8/19/97. Firm-initiated recall complete.
DISTRIBUTION Ohio, Georgia, Connecticut, Nebraska, California,
Florida, Massachusetts, New York, Switzerland.
QUANTITY a) 121 units; b) 59 units; c) 12 units; d) 59
units; e) 13 units; f) 8 units; g) 109 units were
distributed.
REASON Blood products tested negative for the antibody to
the human immunodeficiency virus type 1 (HIV-1),
but were collected from donors who previously
tested repeatedly reactive for the antibody, and
were improperly re-entered.

_______________
PRODUCT Platelets. Recall #B-1016-8.
CODE Unit #10531-1475.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on December 8, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product with visible aggregates was not
quarantined and was distributed for transfusion.

_______________
PRODUCT Platelets. Recall B-1017-8.
CODE Unit #10581-2627.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on February 10, 1998. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product had an inadequate rest time during
preparation.

_______________
PRODUCT Platelets. Recall #B-1018-8.
CODE Unit #10578-4312.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on January 18, 1998. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit were distributed.
REASON Blood product had an inadequate rest time during
preparation.

_______________
PRODUCT Red Blood Cells. Recall #B-1044-8.
CODE Unit #11LX51668.
MANUFACTURER American Red Cross Blood Services, St. Louis,
Missouri.
RECALLED BY Manufacturer, by telephone on November 4, 1997,
and by letter on November 5, 1997. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving
information concerning post donation illness.

_______________
UPDATE Recall #B-856/857-8, Red Blood Cells and
Platelets, recalled by Michigan Community Blood
Centers, which appeared in the April 8, 1998
Enforcement Report should read:
CODE: Unit #34-34277.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Whole Blood. Recall #B-617-8.
CODE Unit #21X74322.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on November 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
subsequently reported a post donation infection,
was distributed after receipt of the information.

_______________
PRODUCT Red Blood Cells, Leukocytes Reduced.
Recall #B-949-8.
CODE Unit numbers: 0492767, 0491431, 0491454, 0493502, 0491327, 0490823, 0490825, 0490822, 0491322, 0491323,
0490829.
MANUFACTURER Bergen Community Regional Blood Center, Paramus,
New Jersey.
RECALLED BY Manufacturer, by telephone on October 23, 1995.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 11 units were distributed.
REASON Unlicensed blood product was distributed in
interstate commerce.

_______________
PRODUCT Red Blood Cells. Recall #B-1008-8.
CODE Unit numbers: 24KK75899 and 24KL19126.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letter dated November 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana and Kentucky.
QUANTITY 2 units were distributed.
REASON Blood products were stored at unacceptable
temperatures.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Liebel-Flarsheim brand CT9000 Contrast Media
Injectors, Catalog #800001, used to infuse known
quantities of radiopaque contrast medium at a
predetermined rate into a patient's vascular
system which enhances diagnostic images obtained
with Computed Tomography (CT). Recall #Z-529-8.
CODE All units distributed since December 1992. The
serial numbers for the first and last units
manufactured are: 1292-0100 and 1197-2589,
respectively.
MANUFACTURER Liebel-Flarsheim Company, Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter on March 26, 1998,
followed by telephone beginning on April 16, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,405 units were distributed.
REASON The screw in the injector's pivot assembly, which
holds the powerhead, may become loose or break and
result in the powerhead falling down onto an
individual standing directly under or nearby the
falling component.

_______________
PRODUCT Genzyme SaphLITE Products, a sterile, disposable
device that is intended for use with the SaphLITE
Saphenous Vein Retractor. These components,
together with the light source and fiberoptic
light cable, make up the Saphenous Vein System
which is intended as a less invasive means to
harvest the saphenous vein: a) SaphLITE Saphenous
Vein Retractor, Part #89-2710; b) SaphLITE
Fiberoptic Light Panel, Part #89-2711. Recall #Z-530/531-8.
CODE Light Panel - 89-2711 and Retractor - 89-2710.
MANUFACTURER Genzyme Surgical Products, Tucker, Georgia.
RECALLED BY Manufacturer, by telephone and letter on March 13,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY a) 52 units; b) 654 units were distributed.
REASON If the light panel is placed in direct contact
with a secondary surface, the optical properties
of the light panel may change, causing heat
transfer to occur which may be excessive and
present a risk of burn to the user or patient.

_______________
PRODUCT Organon Teknika MDA-180 Coagulation Analyzer
Version B Software, Part #22518-21, Revision
#10.Q06.03. Recall #Z-525-8.
CODE None.
MANUFACTURER Organon Teknika Corporation, Oklahoma City,
Oklahoma
RECALLED BY Manufacturer, by letter on March 25, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 209 units were distributed.
REASON This version of the software contains an error in
a data file that controls the washing cycle which
may cause carry-over from the previous test.

_______________
PRODUCT Sysmex CA-6000 Automated Coagulation Analyzer, a
fully automated, computerized blood plasma
coagulation analyzer for in-vitro diagnostic use
in clinical labs:
a) Catalog No. B4260-6200, Chromogenic instrument;
b) Catalog No. B4260-6300, Chromogenic upgrade
kit. Recall #Z-527/528-8.
CODE All serial numbers.
MANUFACTURER TOA Medical Electronics, Company, Ltd., Kobe,
Japan.
RECALLED BY Dade Behring, Inc., Miami, Florida, by telephone
on March 20, 1998, followed by letter on March 30,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Colombia, Mexico, Peru, Canada.
QUANTITY 118 devices were distributed.
REASON Carry-over of the Antithrombin III Substrate
Reagent with testing when using the random access
mode may result in falsely low sample values.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT COBAS INTEGRA Ion-Selective Electrode for
Chloride, designed for the quantitative
determination of sodium, potassium chloride and
lithium in serum and plasma, and of sodium,
potassium and chloride in urine, Product Code No.
1046268. Recall #Z-526-8.
CODE Lot Nos. 436 and 037.
MANUFACTURER Roche Diagnostic Systems, Kaiseraugst,
Switzerland.
RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey,
by letter on March 31, 1997. Firm-initiated
recall complete.
DISTRIBUTION New Jersey, New York, Connecticut, Pennsylvania,
North Carolina, Florida, Alabama, Kentucky, Ohio,
Louisiana, Arkansas, Texas.
QUANTITY a) 30 units; b) 10 units were distributed; firm
estimates none remains on the market.
REASON The device may give falsely elevated chloride
values in samples containing salicylate.

_______________
PRODUCT Rheumaton(TM) 2-Minute Hemagglutination Slide Test
for the Determination of Rheumatoid Factor:
a) Product No. 35D2, Test Kit Size - 20 Tests;
b) Product No. 35D4, Test Kit Size - 50 Tests;
c) Product No. 35D6, Test Kit Size - 150 Tests.
Recall #Z-532/534-8.
CODE Lot numbers: a) 5HG1702, 5HG3102, and 5HH1001; b) 5HH0301, 5HH0902, 5HH1002, 5HH1101, and 5HH1601; c)
5HG1407, 5HG1701, and 5HH1603.
MANUFACTURER Wampole Laboratories, Cranbury, New Jersey (own
label distributor).
RECALLED BY Carter Wallace, Inc., Cranbury, New Jersey, by
telephone starting March 21, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Lot # Amount Shipped
5HG1407 116 (150 tests per kit)
5HG1701 428 (150 tests per kit)
5HG1702 325 (20 tests per kit)
5HG3102 429 (20 tests per kit)
5HH0301 299 (50 tests per kit)
5HH0902 406 (50 tests per kit)
5HH1001 110 (foreign consignment)
5HH1002 597 (foreign consignment)
5HH1101 649 (50 tests per kit)
5HH1601 339 (50 tests per kit)
5HH1603 299 (150 tests per kit).
Firm estimates none remain on the market.
REASON Low amboceptor concentrations in the Rheumaton
reagent can result in reduced test sensitivity.

_______________
PRODUCT Zimmer F/M Acetabular Shell, 50 mm, indicated for
use in surgery for rehabilitating hip damaged as a
result of a variety of disease processes. Recall
#Z-535-8.
CODE Lot #12835500.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by letter on January 21, 1998, and
by E-mail on March 4, 1998. Firm-initiated recall
complete.
DISTRIBUTION Texas, Tennessee, France, Italy, Japan, Greece,
Germany, The United Kingdom.
QUANTITY 33 units were distributed.
REASON An incorrect size is etched onto the inside of the
shell. The shell is actually 50 mm, but 52 mm is
etched onto the shell. The carton label and the
interior patient record label bear the correct
size indication.

_______________
PRODUCT Versy Beaded Full Coat Stem Hip Prosthesis:
a) Catalog No. 00-7843-012-08;
b) Catalog No. 00-7843-013-08;
c) Catalog No. 00-7843-014-08;
d) Catalog No. 00-7843-015-08;
e) Catalog No. 00-7843-016-08;
f) Catalog No. 00-7843-017-08;
g) Catalog No. 00-7843-018-08;
h) Catalog No. 00-7843-020-08.
Recall #Z-536/543-8.
CODE All lots.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by E-mail and certified mail on
February 4, 1998. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, England, Japan.
QUANTITY 424 units were distributed.
REASON Adhesive from pressure sensitive tape used during
manufacturer adhered to the device, contaminating
the device.

_______________
UPDATE Recall #Z-522/524-8 which appeared in the April
29, 1998, Enforcement Report should be replaced
with the following:
PRODUCT Rheumaton(TM) 2-minute Hemagglutination Slide Test
for the quantitative and qualitative determination
of rheumatoid factor in serum or synovial fluid:
a) Product #35D2, Test Kit Size - 20 Tests
b) Product #35D4, Test Kit Size - 50 Tests,
c) Product #35D6, Test Kit Size - 150 Tests.
Recall #Z-522/524-8.
CODE Lot Numbers: a) 3G7233D; b) 3G7233A and 3G7233E
c) 3G7233 and 3G7233Z.
MANUFACTURER Wampole Laboratories, Cranbury, New Jersey (own
label distributor).
RECALLED BY Carter-Wallace, Inc., Cranbury, New Jersey
(responsible firm),by telephone starting February
7, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Lot # Amount Shipped
3G7233 623 (150 tests per kit)
3G7233A 4427 (50 tests per kit)
3G7233D 180 (foreign consignment)
3G7233E 175 (foreign consignment)
3G7233Z 846 (150 tests per kit)
REASON Low amboceptor concentrations in the Rheumaton
Reagent can result in reduced test sensitivity.

END OF ENFORCEMENT REPORT FOR MAY 6, 1998. BLANK PAGES MAY FOLLOW.

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