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
03/06/1996
ENFORCEMENT REPORT FOR 03/06/96
March 6, 1996 96-10
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT (a) Chocolate Fudge Brownie Frozen Yogurt,
packed in one-half gallon cartons and 3 gallon
bulk boxes; (b) Purely Chocolate Frozen
Yogurt, packed in one half gallon cartons.
Recall #F-311/312-6.
CODE Lot #96DEC01. Product flavor numbers:
(a) 00869; (b) 00980.
MANUFACTURER Friendly Ice Cream Corporation, Troy, Ohio.
RECALLED BY Friendly Ice Cream Corporation, Wilbraham,
Massachusetts, by letter mailed on December
29, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Pennsylvania, Michigan, Virginia,
Connecticut, Delaware, Florida, Maine,
Maryland, Massachusetts, New Hampshire, New
York, Rhode Island, Vermont, New Jersey.
QUANTITY 396 boxes of the chocolate fudge brownie
frozen yogurt, 3 gallon size; approximately
14,016 cartons of the chocolate fudge brownie
yogurt, one-half gallon size; and 8,370
cartons of the purely chocolate frozen yogurt,
one-half gallon size were distributed.
REASON Products are or may be contaminated with
Listeria monocytogenes.
_______________
UPDATE Recall #F-260-6 which appeared in the February
7, 1996 Enforcement Report should read:
PRODUCT: Hearth Oven and America's Choice
brand Confetti Cookies. The recalled product
did not include "President's Choice: brand.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT NewPak Enteral Nutritional Feeding Products,
in 1 liter size plastic bottles: (a) Isolan;
(b) Isolan Colorcheck; (c) Nitrolan; (d)
Nitrolan Colorcheck; (e) Fiberlan; (f)
Fiberlan Colorcheck. Recall #F-313/318-6.
CODE Part No. Lot No.
(a) NP5000 950423, 950518, 950516, 950219,
950305
(b) NPBL5000 950219, 950305,
(c) NP5200 950514, 950115, 950226,
950502,
(d) NPBL5200 950115, 950226
(e) NP5300 950507, 950523, 941211
(expired)
(f) NPBL5300 950626, 950108 (expired).
MANUFACTURER Imperial Flavors, Inc., Mississauga, Ontario,
Canada.
RECALLED BY Elan Pharma, Inc., Smithfield, Rhode Island,
by letters issued August 30 and 31, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Lot No. Part No. Quantity Distributed
950423 NP5000 2130
950516 NP5000 455
950518 NP5000 50
950219 NP5000 28
950305 NP5000 29
950219 NPBL5000 49
950305 NPBL5000 12
950115- NP5200 1728
950115-- NP5200 282
950226 NP5200 2024
950514 NP5200 1452
950514A NP5200 54
950502 NP5200 4
950115 NPBL5200 615
950226- NPBL5200 298
950226-- NPBL5200 276
950226= NPBL5200 72
950507 NP5300 2142
950523 NP5300 182
941211 NP5300 7 (expired)
-2- 950626 NPBL5300 228
950108 NPBL5300 6 (expired) .
REASON Products are subpotent in calcium content.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Red Wine Vinegar, in glass bottles.
Recall #F-305-6.
CODE None.
MANUFACTURER Todhunter Foods, Lake Alfred, Florida.
RECALLED BY Flora Distributors, Inc., Pompano Beach,
Florida, by letters providing sticker labels.
Firm-initiated recall ongoing.
DISTRIBUTION Florida, New York.
QUANTITY 1,090 cases were distributed.
REASON Product contains undeclared sulfites.
_______________
PRODUCT Corn Muffins and Bran Muffins in 14 ounce
boxes, under the Viking and Waldbaum label.
Recall #F-306/307-6.
CODE Sell by date of DEC02 1995.
MANUFACTURER Operative Cake Company, West Hartford,
Connecticut.
RECALLED BY Operative Cake Company, Long Island City, New
York, by visit on December 1, 1995. Firm-
initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1,678 boxes of corn muffins and 906 boxes of
bran muffins were distributed.
REASON Products were contaminated with rodent filth
and were prepared, packed, and held under
insanitary conditions.
_______________
PRODUCT Medford Farms Fat Free Ranch Dressing, in 12
fluid ounce glass bottles. Recall #F-308-6.
CODE Lot #"JO117A" ink printed on the product
shipper label and on the bottle glass above
the label.
MANUFACTURER Chelten House Products, Inc., Bridgeport, New
Jersey.
RECALLED BY Haddon House Food Products, Inc., Medford, New
Jersey, by letter December 28, 1995. FDA-
initiated recall complete.
DISTRIBUTION New Jersey, Delaware, Pennsylvania, New York,
Maryland, Connecticut.
QUANTITY 753 bottles were distributed.
REASON Product is unfit for food due to spoilage.
-3- _______________
PRODUCT Bavarian Filling Premium and Bavarian Cream
Premium in 20 pound and 40 pound plastic
pails, for use in cream pies, eclairs and
donuts. Recall #F-309/310-6.
CODE All codes.
MANUFACTURER Aliments Plasse Foods Inc., Chateauguay,
Quebec, Canada.
RECALLED BY Saratoga Flour Corporation, Saratoga Springs,
New York, by telephone beginning on January
19, 1996, followed by letter dated January 23,
1996. Firm-initiated recall ongoing.
DISTRIBUTION New York, Vermont, Massachusetts.
QUANTITY 50 20-pound pails and 142 40-pound pails were
distributed; firm estimated that 31 40-pound
pails and 4 20-pound pails remained on market
at time of recall initiation.
REASON Products are acidified foods, but no process
has been field with the FDA.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Leucovorin Calcium Tablets USP, 15 mg, in
bottles of 12 or 24 tablets, and in unit dose
blister packs containing 10 tablets per
carton-pack, used as an antidote to the
harmful effects of methotrexate (a cancer
medicine). Recall #D-092-6.
CODE Lot numbers: 951186, 951186A EXP 5/1/97,
951186 EXP 11/1/96 (blister packs).
MANUFACTURER Roxane Laboratories, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter sent on February 23,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 204 24-tablet bottles, 55 12-tablet bottles,
and 39 unit dose packs totaling 5,946 tablets
were distributed.
REASON Product may not maintain dissolution
specifications through expiration date.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Bulk Cocaine Hydrochloride USP, C-II, packaged
in 5-gm bottles and 1-, 13.230-, 6.300-, and
23.000-kg containers, Rx for manufacturing,
processing, or repacking. Recall #D-093-6.
CODE Lot numbers: SPK288, SPK289, SPM294, T00254,
SPP298, SPP299, SPP301.
MANUFACTURER Mallinckrodt Chemical, Inc., St. Louis,
Missouri.
-4- RECALLED BY Manufacturer, by letter dated February 20,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 43.53 kg. containers and 510 6-gm bottles were
distributed.
REASON Microbial contamination Bacillus species.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-147-6.
CODE Unit #27032-9914.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Texarkana, Texas.
RECALLED BY Manufacturer, by telephone on October 6, 1994,
followed by letter dated October 14, 1994.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which was tested repeatedly
reactive for anti-HTLV-I, WB indeterminate,
was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-201/202-6.
CODE Unit #M16983.
MANUFACTURER Northern California Community Blood Bank,
Eureka, California.
RECALLED BY Manufacturer, by letters dated April 14, 1994,
and May 15, 1995. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood products, which was collected from a
donor with a history of nose piercing within
twelve months of donation, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Granulocyte
Concentrate; (c) Cryoprecipitated AHF; (d)
Recovered Plasma. Recall #B-204/207-6.
CODE Unit numbers: (a) 01H33759, 01K29014;
(b) 01P11262; (c) 01H33759; (d) 01J63292,
01J66503, 01GG03665, 01K48578, 01X90401,
01K36694, 01K29014, 01H33759.
MANUFACTURER American Red Cross Blood Services, Rochester,
New York.
RECALLED BY Manufacturer, by letters dated between October
12, 1994 and July 25, 1995. Firm-initiated
recall complete.
DISTRIBUTION New York, California, Switzerland.
-5- QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 8
units.
REASON Blood products, which tested non-reactive (NR)
for HBsAg but were collected from donors who
previously tested repeatedly reactive (RR) for
HBsAg, with no confirmatory test; were
collected from a donor who tested initially
reactive (IR) for HBsAg and not retested as
required, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitate AHF;
(c) Platelets; (d) Leukocyte Poor Platelets
(Pooled); (e) Fresh Frozen Plasma; (f)
Recovered Plasma. Recall #B-209/214-6.
CODE Unit numbers: (a) 01W09843, 01H77729,
01X15546, 01H87146, 01G85145, 01G98601;
(b) 01X15546; (c) 01H87146, 01G85145, 01G98601
(d) 01W09843; (e) 01W09843, 01G85145
(f) 01H77729, 01X15546, 01H87146, 01G98601.
MANUFACTURER American Red Cross, Rochester, New York.
RECALLED BY Manufacturer, by letters dated April 6, 1995,
April 24, 1995, and August 23, 1995. Firm-
initiated recall complete.
DISTRIBUTION New York, Maryland, California, Switzerland.
QUANTITY (a) 6 units; (b) 1 unit; (c) 3 units; (d) 1
unit; (e) 2 units; (f) 4 units.
REASON Blood products, which tested non-reactive to
anti-HIV-1, but collected from a donor who
previously tested RR for anti-HIV-1, WB
negative donor was subsequently re-entered
improperly, were distributed.
_______________
PRODUCT (a) Red Blood Cells for further manufacture;
(b) Recovered Plasma. Recall #B-234/235-6.
CODE Unit numbers: (a) 04W67848, 04W63532; (b)
04W62741, 04W67848, 04W67249, 04W63532.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by telephone on September 1,
1992, and by letter dated September 2, 1992.
Firm-initiated recall complete.
DISTRIBUTION California, Massachusetts, Switzerland.
QUANTITY (a) 2 units; (b) 4 units.
REASON Blood products, which tested negative for the
hepatitis B surface antigen (HBsAg), but were
collected from a donor who previously tested
repeatedly reactive for HBsAg, were
distributed.
-6- _______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-238/239-6.
CODE Unit #49F69270.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letter dated May 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Texas, Oklahoma.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor whose
husband was previously an intravenous (IV)
drug user, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF;
(c) Recovered Plasma. Recall #B-248/250-6.
CODE Unit #12F64652.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated June 12, 1995,
and by fax on June 12, 1995. Firm-initiated
recall complete.
DISTRIBUTION North Carolina, California.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor taking
the drug Proscar, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-257-6.
CODE Unit #29GV05295.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letter dated June 5, 1995.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit.
REASON Blood product collected from a donor with a
history of cancer was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-262-6.
CODE Unit #12FV53620.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on June 1, 1995,
followed by letter dated June 2, 1995. Firm-
initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
-7- REASON Blood product, collected from a donor who had
traveled to an area designated as endemic for
malaria, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-263-6.
CODE Unit #12FZ23466.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by letter dated June 27, 1995.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had
traveled to an area designated as endemic for
malaria, was distributed.
_______________
PRODUCT Source Plasma. Recall #B-264-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301-594-
1070 for individual unit numbers recalled.
MANUFACTURER Community Bio-Resources, Inc., Birmingham,
Alabama.
RECALLED BY Manufacturer, by letter dated August 11, 1994.
Firm-initiated recall complete.
DISTRIBUTION California, North Carolina New Jersey,
Germany.
QUANTITY 723 units.
REASON Source Plasma which tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-I), but was collected from
donors who previously tested repeatedly
reactive for anti-HIV-1; tested negative for
the hepatitis B surface antigen (HBsAg), but
was collected from donors who previously
tested repeatedly reactive for HBsAg; or was
collected from donors with a history of
intravenous (IV) drug use, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-274/276-6.
CODE Unit #11033-7162.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, El Paso, Texas.
RECALLED BY Manufacturer, by letters dated October 30,
1995 and November 6, 1995. Firm-initiated
recall complete.
DISTRIBUTION Texas, North Carolina.
QUANTITY 1 unit of each component.
-8- REASON Blood products, collected from a donor who
tested NR for HBsAg, but who previously tested
RR for HBsAg and donor subsequently reentered,
were distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-280-6.
CODE Unit numbers: KZ24929, KZ24930, KZ24931.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on or about
December 8, 1995. Firm-initiated recall
complete.
DISTRIBUTION Maryland, Texas, Virginia.
QUANTITY 3 unit.
REASON Blood products, labeled with an extended
expiration date, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-245-6.
CODE Unit numbers: 2656196, 2656197, 2656206,
2656209, 2656216, 2656217, 2656219, 2656229.
MANUFACTURER Irwin Army Community Hospital, Fort Riley,
Kansas.
RECALLED BY Manufacturer, by telephone on April 26, 1994.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 8 units.
REASON Blood products which were labeled with an
extended expiration date were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-246/247-6.
CODE Unit #55H28023.
MANUFACTURER American Red Cross Blood Services, Little
Rock, Arkansas.
RECALLED BY Manufacturer, by telephone on January 25 and
26, 1995, followed by letter dated February 2,
1995. Firm-initiated recall complete.
DISTRIBUTION Arkansas and Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who had
been immunized with Measles, Mumps, and
Rubella (MMR) vaccine, were distributed.
_______________
PRODUCT Whole Blood. Recall #B-277-6.
CODE Unit #2664461.
MANUFACTURER Houchin Community Blood Bank, Bakersfield,
California.
-9- RECALLED BY Manufacturer, on August 18, 1995. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, labeled with an extended
expiration date, was distributed.
_______________
PRODUCT Red Blood Cells, Irradiated. Recall #B-283-6.
CODE Unit #35R00919.
MANUFACTURER American Red Cross Blood Services, Roanoke,
Virginia.
RECALLED BY Manufacturer, by telephone on or about July
26, 1994, followed by letter dated August 11,
1994. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit.
REASON Blood product labeled with an extended
expiration date was distributed.
_______________
PRODUCT Source Plasma. Recall #B-284-6.
CODE Bleed Number and Donor Number:
0530050101 00530066939
0530050102 00530066947
0530050103 00530066629
0530050105 00530067170
0530050106 00530066050
0530050107 00530062143
0530050109 00530066793
0530050110 00530044633
0530050111 00530058219
0530050113 00530037599
0530050116 00530044358
0530050117 00530058898
0530050118 00530055805
0530050124 00530057581
0530050126 00530066866
0530050253 0530018951
0530050254 0530029880
0530050256 0530023148
0530050262 0530067161
0530050263 0530065991
0530050264 0530013665
0530050265 0530018560
0530050267 0530034883
0530050268 0530064901
0530050270 0530058286
0530050271 0530057743
0530050274 0530053934
0530050275 0530022532
0530050279 0530020009
0530050281 0530014505
-10- MANUFACTURER North American Biologicals, Inc., NABI
BioMedical Center, Lexington, Kentucky.
RECALLED BY Manufacturer, by letter dated March 7, 1995.
Firm-initiated recall complete.
DISTRIBUTION Germany.
QUANTITY 30 units.
REASON Source Plasma, stored at an unacceptable
temperature, and not relabeled as Source
Plasma, Salvaged, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Zimmer Bone Cement Powder Component:
(a) 40 gm. Powder, 20 cc. Liquid, Catalog No.
00-1102-012-00;
(b) 60 gm. Powder, 30 cc. Liquid, Catalog No.
00-1102-013-00;
(c) Z-420-6 - 20 gm. Powder, 10 cc. Liquid,
Catalog No. 00-1102-016-00;
(d) 80 gm. Powder, 40 cc. Liquid, Catalog No.
00-1102-030-00,
(e) 80 gm. Powder, 40 cc. Liquid (Box of 5
Kits), Catalog No. 00-1102-040-00,
(f) 40 gm. Powder, 20 cc. Liquid (Box of 10
Kits), Catalog No. 00-1102-022-00,
(g) 60 gm. Powder, 30 cc. Liquid (Box of 10
Kits), Catalog No. 00-1102-023-00,
(h) 20 gm. Powder, 10 cc. Liquid (Box of 10
Kits), Catalog No. 00-1102-026-00.
Recall #Z-418/425-6.
CODE Lot numbers: (a) 60750200, 61194300,
61793100, 61793200, 62282200, 63807400; (b)
62724600; (c) 61144300; (d) 63245300; (e)
63245200; (f) 60750100; 61194200; 61793300;
62282100; 63807300; (g) 62724500;
(h) 61144200.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by letters sent on April 26 and
28, 1995, May 26, 1995, June 27, 1995, and
July 7, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 12,967 kits were distributed.
REASON The devices have a potential for seal defects
which might affect product sterility.
_______________
PRODUCT ArthroWand Electrophysical cutting tool with
either a straight tip, 15 degree tip, or 90
degree tip packaged in blister pak:
(a) ArthroWand 2.5 mm Straight Tip, Catalog
No. A1125-01;
-11- (b) ArthroWand 2.5 mm 15 degree Curved Tip,
Catalog No. A1225-01;
(c) ArthroWand 2.5 mm 90 degree Curved Tip,
Catalog No. A1325-01;
(d) ArthroWand 3.0 mm Straight Tip, Catalog
No. A1130-01. Recall #Z-454/457-6.
CODE Lot numbers: (a) 0120251, 0120751, 0123351;
(b) 0220551, 0223451; (c) 0321951, 0321956;
(d) 0521351.
MANUFACTURER Arthro-Care Corporation, Sunnyvale,
California.
RECALLED BY Manufacturer, by letter sent on or about
October 29, 1995. Firm-initiated recall
complete.
DISTRIBUTION Arizona, California, Florida, New Jersey,
Maryland, Pennsylvania.
QUANTITY 61 units were distributed.
REASON Sterility may be compromised due to cracks in
the tray package.
_______________
PRODUCT Baxter Custom Procedural Packs which contain
Johnson & Johnson Barrier Vu-Thru
Cardiovascular Split Sheets:
(a) Catalog #SCV41BSWAA, Sterile
Cardiovascular Pack;
(b) Catalog #SCV630HJWD, Sterile Open Heart
Pack. Note: this pack was further packaged in
to Open Heart Kits, Catalog #PC630OHJHA and
PC630OHJHB. Recall #Z-478/479-6.
CODE (a) Order #171017, EXP date 9/30/97
(b) Order #169948, EXP date 11/30/96.
MANUFACTURER Baxter Custom Sterile Division, McGaw Park,
Illinois.
RECALLED BY Baxter Healthcare Corporation, McGaw Park,
Illinois, by letter sent on December 20 and
21, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Kentucky and Texas.
QUANTITY (a) 14 kits; (b) 111 kits were distributed.
REASON The fabric of the clipping tabs is subject to
tearing, which could result in unsecured lines
presenting potential harm to the patient.
_______________
PRODUCT Incstar Rubeola IGM CLIN-ELSIA Test Kit., an
in-vitro diagnostic test kit for detecting
antibodies inhuman serum to the Rubeola virus
which causes measles. Recall #Z-480-6.
CODE Catalog No. 5600, Lot Nos. 142155, 262305,
262305A, 352205, 352205A, and Sigma
Diagnostics "SIA Measles IgM Kit," Product No.
SIA134A, Lot No. 035H6357.
-12- MANUFACTURER Incstar Corporation, Stillwater, Minnesota.
RECALLED BY Manufacturer, by letter sent on January 12,
1996. Firm-initiated recall ongoing.
DISTRIBUTION California, Missouri, New York, Pennsylvania,
Tennessee, Washington state, England, Mexico,
Italy.
QUANTITY 83 test kits were distributed.
REASON The some negative samples may yield a positive
assay response.
_______________
PRODUCT Smith & Nephew Richards Power Reamer, Part
#11-0023, used to drill holes of two different
diameters in femur for implantation of a
compression hip screw. Recall #Z-481-6.
CODE Lot numbers: 41111267, 41111276, 50102088,
50190042, 50190051A, 50207052, 50207052A,
50207054, 50207205, 50207205A, 50304810,
50304812, 50304815, 50304817, 50304818,
50311074, 50311075, 50311076, 50409606,
50409607, 50409608, 50409609, 50409610,
50608231.
MANUFACTURER Smith & Nephew Richards, Memphis, Tennessee.
RECALLED BY Manufacturer, by letters dated September 21
and 27, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 589 reamers were distributed.
REASON An unexpected slippage of the barrel reamer
could result in drilling a greater depth hole
than set and desired.
_______________
PRODUCT Zimmer Ceramic Femoral Heads for tapered neck
femoral hip stems:
(a) Catalog No. 00-9029-020-00;
(b) Catalog No. 00-9029-021-00;
(c) Catalog No. 00-9029-022-00;
(d) Catalog No. 00-9029-030-00;
(e) Catalog No. 00-9029-031-00;
(f) Catalog No. 00-9029-032-00.
Recall #Z-485/490-6.
CODE All lot numbers.
MANUFACTURER Cerasiv GMBH, Plochingen, Germany.
RECALLED BY Zimmer, Inc., Warsaw, Indiana, by letters sent
February 6 and 8, 1995, and March 1, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 2,719 units were distributed.
REASON There was a potential for fracture under
certain extreme conditions.
-13- RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Kodak Ektachem Clinical Chemistry Slide for
Theophylline (THEO), an in-vitro product for
the quantitative measurement of theophylline
in serum or plasma. Recall #Z-473-6.
CODE Catalog No. 1900117, Lot numbers:
2407-0017-3726, 2407-0017-3727,
2407-0017-3728.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Inc.,
formerly known as Eastman Kodak Company,
Clinical Diagnostics Division, Rochester, New
York.
RECALLED BY Johnson & Johnson Clinical Diagnostics, Inc.,
Rochester, New York, by letter mailed January
12, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 3,498 cartridges were distributed.
REASON The Theophylline slides can produce falsely
elevated results.
_______________
PRODUCT IL Test Digoxin Kits. Each kit contains: 1 x 4
mL of Digoxin P reagent (pretreatment ready
for use), 1 x 5.0 mL Digoxin A reagent
(antibody reagent lyophilized), 2 x 8.0 mL
Digoxin E reagent (enzyme reagent
lyophilized), 1 x 3 mL glass vials of
Calibrators: A, B, C, & E and 2 x 3 mL glass
vials of Calibrator D.intended to be used for
the Quantitative in-vitro diagnostic
determination of total Digoxin (protein bound
plus unbound) in serum using the IL Monarch
Chemistry System. Recall #Z-474-6.
CODE Catalog No. 35280, Lot Nos. Kit N0843419,
Calibrator A: N0843414R, Calibrator B:
N0843415R, Calibrator C: N0843416R, Calibrator
D: N0843417R, Calibrator E: N08431418R.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company, (ILC),
Lexington, Massachusetts, by letter dated
September 20, 1994. Firm-initiated recall
complete.
DISTRIBUTION Georgia, South Carolina, Mississippi, Arizona,
Pennsylvania, Nebraska, Louisiana, Texas,
Florida, Colorado, New Mexico, Minnesota,
Virginia.
QUANTITY 42 kits were distributed.
REASON The calibrators were mislabeled with the wrong
concentrations.
-14- _______________
PRODUCT IL Test(tm) Amylase Reagent, intended for the
quantitative in-vitro diagnostic determination
of amylase in serum or urine samples using the
IL Monarch Chemistry Systems.
Recall #Z-475-6.
CODE Catalog #35314; Lot numbers: N1032762,
N1233454, N0732759.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, new york.
RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by letter dated May
27, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,254 kits were distributed.
REASON The Amylase reagent when used on the Monarch
Chemistry System had a stability drop well
short of the 4-week expiration date.
_______________
PRODUCT IL Test(tm) ReferrIL G Calibrator, a
multicomponent calibrator for use in the
calibration of substrate assays using the
ILab(tm) Chemistry Systems, for in-vitro
diagnostic use. Recall #Z-476-6.
CODE Catalog #181635.10, Lot numbers N1143595,
N0453787.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by letters dated May
17, 1995 and August 9, 1995, followed by
telephone on September 21, 1995. Firm-
initiated recall complete.
DISTRIBUTION California, Maryland, Illinois, Florida, Ohio
Connecticut, Virginia, Georgia, Arkansas,
Arizona, Kentucky, Texas, Montana, Puerto
Rico, Canada, Mexico.
QUANTITY 2,187 packages were distributed.
REASON The labeled analyte concentrations for glucose
oxidase, Glucose Hexokinase, cholesterol, HDL,
calcium, creatine and T. bilirubin are
incorrect.
SEIZURES: ==================================================
_______________
PRODUCT Bean sprouts and Chinese vegetables
(95-741-130).
CHARGE Adulterated - The articles were prepared and
packed under conditions whereby they may have
been rendered injurious to health.
LOCATION Worldwide Trading Co. doing business as
Chinese Maid, Chicago, Illinois.
-15- FILED January 22, 1996; U.S. District Court for the
Northern District of Illinois, Eastern
Division; Civil #96C 0415; FDC #67070A.
SEIZED January 23, 1996 - goods valued at
approximately $42,000.
_______________
PRODUCT Bean sprouts (95-760-912).
CHARGE Adulterated - The article was prepared and
packed under conditions whereby it may have
been rendered injurious to health.
LOCATION Chicagoland Quad Cities Express, Bridgeview,
Illinois.
FILED February 7, 1996; U.S. District Court for the
Northern District of Illinois, Eastern
Division; Civil #96C 0708; FDC #67125.
SEIZED February 8, 1996 - goods valued at
approximately $12,870.
-16-
END OF ENFORCEMENT REPORT FOR MARCH 6, 1996. BLANK PAGES MAY
FOLLOW.
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