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.
April 15, 1998 98-15
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Acidified foods packaged in glass jars under the
Goodies Delight label:
a) Bread N' Butter Pickles, 8 oz. jar
b) Chow Chow, 8 oz. jar
c) Candied Cucumber Rings, 8 oz. jar
d) Corn Relish, 16 oz. jar
e) Golden Glow Pickles, 8 oz. jar
f) Hot Pepper Jelly, 16 oz. jar
g) Jalapeno Peppers, 32 oz. jar
h) Mustard Dill Pickles, 8 oz. jar
I) Pickled Okra, 8 oz. jar
j) Pickled Watermelon Rinds, 8 oz. jar
k) Ripe Tomato Pickles, 32 oz. jar
l) Squash Delight, 16 oz. jar
m) Sweet Pickles, 32 oz. jar
n) Sweet N' Sour Zucchini Pickles, 32 oz. jar
o) Zucchini Bread N' Butter Pickles, 16 oz.
jar
p) Zucchini Relish, 32 oz. jar
q) Zucchini Sweet Pickles, 16 oz. jar
Recall #F-340/356-8.
CODE None.
MANUFACTURER Goodies Delight, Whitesville, North Carolina.
RECALLED BY Manufacturer, by telephone on March 11, 1998.
Ongoing recall resulted from sample analysis and
follow-up by the North Carolina Department of
Agriculture.
DISTRIBUTION South Carolina, North Carolina.
QUANTITY 20 12-pint jar cases (240 jars) were distributed.
REASON The products had been manufactured and processed
without the firm keeping mandatory manufacturing
records or filing its scheduled process for each
product.
_______________
PRODUCT Chicken Gravy Mix in 1 oz. Packages and Country
Gravy Mix in 1.25 oz. Packages:
a) Chicken Gravy Mix, under the private labels
Sauce Classics, distributed by Han-Dee Pak, Inc.,
Cockeysville, Maryland and Hill Country Fare,
distributed by H-E-B, San Antonio, Texas
b) Country Gravy Mix, under the private labels Our
Family, distributed by Nash Finch Company,
Minneapolis, Minnesota and Spartan, distributed by
Spartan Stores, Inc., Grand Rapids, Michigan.
Recall #F-443/444-8.
CODE Date Code: 2361AH (Sauce Classics Chicken Gravy
only) and 2361BH.
MANUFACTURER Ampacco, Inc., Hunt Valley, Maryland.
RECALLED BY Manufacturer, by letter on March 17, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 324 cartons (24 packages/carton) of Our Family
Country Gravy was produced and distributed;
604 cartons of Spartan Country Gravy Mix were
produced and distributed; 124 cartons of Hill
Country Fare Chicken Gravy Mix were produced and
distributed; 600 cartons of Sauce Classics Chicken
Gravy Mix were produced and distributed.
REASON The Chicken Gravy Mix contains undeclared
certified colors (FD&C Yellow No. 5 & 6,) and
lactose. The Country Gravy Mix contains
undeclared milk.
_______________
PRODUCT Cake Mix - individual units are in boxes labeled
as "Duncan Hines White Cake Mix", shipping cartons
are labeled as "Duncan Hines Princess White Cake
Mix". Recall #F-445-8.
CODE 8028E2.
MANUFACTURER Procter and Gamble Company, Jackson, Tennessee.
RECALLED BY Aurora Foods, Inc., Columbus, Ohio, by press
release on March 26, 1998, followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION Canada.
QUANTITY 6,909 cases (82,908 total retail packages) were
distributed; firm estimated that 4,622 cases
(55,464 retail packages) remained on market at
time of recall initiation.
REASON Product contains undeclared soy protein.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Dobutamine in 5% Dextrose Injection, 500 mg (2000
mcg/mL), in 250 mL flexible containers with foil
overwrap, Rx intravenous solution for inotropic
support in the short-term treatment of adults with
cardiac decompensation due to depressed
contractility resulting either from organic heart
disease or from cardiac surgical procedures.
NDC #0074-2347-32. Recall #D-113-8.
CODE 28-488-DR, 28-490-DR, 28-491-DR, 29-497-DR.
MANUFACTURER Abbott Laboratories, North Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated March 20, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and The Netherlands.
QUANTITY 29,952 units were distributed; firm estimated that
3,000 units remained on market at time of recall
initiation.
REASON Mislabeling -- Some correctly labeled 500 mg units
are over wrapped with an incorrect 250 mg foil
labeled pouch.
_______________
PRODUCT Estraderm (Estradiol Transdermal System), 0.1
mg/day, one patch per pouch (8 mg Estradiol USP)
with 8 pouches per carton sold in boxes of 6, a
patch system therapy for estrogen replacement in
post menopausal women.
NDC #0083-2320-62. Recall #D-114-8.
CODE Lot #1F210345 EXP 11/98.
MANUFACTURER Novartis Pharmaceuticals Corporation (formerly
Ciba-Geigy), Suffern, New York.
RECALLED BY Manufacturer, by letters by fax on March 19, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 26,012 packers (each packer contain 6 cartons of 8
systems/individual units) were distributed.
REASON Content uniformity failure - Superpotent.
_______________
UPDATE Inwood Laboratories (Inwood, New York),
Propranolol HCL, Recall #D-100/103-8, which
appeared in the April 1, 1998, Enforcement Report
has been extended to include 61 additional lot
numbers:
*** Additional 23 lots of 60 mg:
6K044 (4/98), 6K045 (4/98), 6L001 (4/98), 6L002
(4/98),6L003 (4/98), 6L004 (4/98), 6L005 (4/98),
6L006 (4/98), 6M033 (4/98), 6M036 (4/98), 6M035
(5/98), 6M037 (5/98), 6M038 (5/98), 7A062 (6/98),
7A065 (6/98), 7B004 (6/98), 7B005 (6/98), 7B006
(6/98), 7B007 (6/98), 7B008 (6/98), 7B022 (8/98),
7B025 (7/98) & 7D010 (11/98).
*** Additional 12 lots of 80 mg:
6H012 (7/98), 6J098 (8/98), 6J099 (9/98), 6K020
(9/98), 6K021 (10/98), 6K022 (11/98), 7A045
(12/98), 7A046 (1/99), 7A047 (1/99), 7C023 (2/99),
7D013 (3/99) & 7C025 (3/99).
*** Additional 11 lots of 120 mg:
6J100 (8/98), 6J101 (9/98), 6K023 (9/98), 6K024
(10/98), 6K025 (10/98), 6K026 (11/98), 7A050
(11/98), 7A051 (12/98), 7A052 (11/99), 7A053
(1/99) & 7C027 (2/99).
*** Additional 15 lots of 160 mg:
6H018 (8/98), 6H028 (8/98), 6J102 (8/98), 6J103
(8/98), 6K029 (10/98), 6K031 (10/98), 6K032
(10/98), 7A054 (11/98),7A055 (11/98), 7A056
(12/98), 7A057 (1/99), 7A058 (1/99), 7C031 (2/99),
7C032 (3/99) & 7F059 (5/99).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Vicodin Tablets (Hydrocodone Bitartrate 5
mg/Acetaminophen 500 mg), 25 tablets in individual
foil packets (1 per packet), intended for the
treatment of moderate to severe pain and was
shipped as physician samples. NDC #0044-0727-91.
Recall #D-112-8.
CODE Lot #10760535 EXP 10/98.
MANUFACTURER Knoll Pharmaceutical Company, Mount Olive, New
Jersey.
RECALLED BY Knoll Pharmaceutical Company, Whippany, New Jersey
(responsible firm), by letter on December 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 54,831 cartons (1,370,775 tablets) were
distributed.
REASON Dissolution failure -(acetaminophen-21 month
stability).
_______________
PRODUCT Oxygen USP Compressed, in high pressure "E"
cylinders. Recall #D-115-8.
CODE Lot numbers: A03H350A, A03H350B, A03H350C
A03H350D, A03H350E, A04H352A, A04H352B
A04H352C, A04H352D, A04H352E, A04H352F
And other lots of unknown coding.
MANUFACTURER G.S. Parsons, doing business as Parsons Airgas,
San Diego, California.
RECALLED BY Manufacturer, by letter dated March 24, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 80 cylinders were distributed.
REASON Misbranding - Some empty cylinders were
re-distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-283-8.
CODE 40GN69533.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on August 21, 1997, and
by letter dated September 15, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor whose
suitability was not adequately determined.
_______________
PRODUCT Red Blood Cells. Recall #B-513-8.
CODE 0392610, 0392619, 0393187, 5237334, 5212148,
5227359, 0392399, 0392423, 0392424, 5215759,
5227768, 5237362.
MANUFACTURER Blood Systems Laboratories, Tempe, Arizona
(testing facility).
RECALLED BY New York Blood Center, Inc., New York, New York,
by letter dated December 31, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION New York and New Jersey.
QUANTITY 12 units were distributed.
REASON Blood products were mislabeled for the Rh(D)
antigen because of failure to follow accepted
testing standards for the determination of the
Rh(D) type.
_______________
PRODUCT Baxter Fenwal Plasmacell-C Disposable Sets,
consisting of the separation device, a reservoir
and a tubing set which provides transport for the
blood and solutions within a closed blood pathway
when used with the Fenwal Autopheresis-C
Plasmapheresis System:
a) 4R2252, Plasmacell-C Separation Disposable Set,
60 units per case
b) 4R2256, Plasmacell-C Separation Disposable Set,
for use with SpikeSmart System, 60 units per case
European distribution:
c) 4R2250, Plasmacell-C Separation Disposable Set
with In-line Anticoagulant Drip Chamber, 60 units
per case
d) D4R2251, Plasmacell-C Separation Disposable Set
with Attached 1000 mL Plasma Collection Bag-French
label
e) R4R2252, Plasmacell-C Disposable Set - multiple
language label
f) 4R2262, Plateletcell Disposable Set with
Preattached Filter and D4R2262 - French label
h) E4R2266, Plasmacell-C TPS Disposable Set for
Therapeutic Plasmapheresis
I) D4R2278, Plasmacell-C Separation Disposable Set
with Pre-Connected Filters (0.22 microns), Needle
and Collection Bags - French label and R4R2278 -
multiple language label Japanese distribution:
j) J4R2252 and J4R2253, Plasmacell-C Separation
Disposable Sets - Japanese label
k) J4R2283 and J4R2284 - Plasmacell-C Disposable
Sets used with the Mini Autopheresis-C with
different membranes - Japanese label. Recall
#B-738-8.
CODE a) 4R2252, lots A97L22103, A97L30114, A98A08053,
A98A08061, A98A09044, A98A09069, A98A14093,
A98A14101, A98A14119, A98A15074, A98A15108,
A98A16098, A98A16106A, A98A21080, A98A23078,
A98A23094, A98A26089, A98A28093, A98B02070,
A98B02096, A98B04100, A98B04118, A98B06055,
A98B10099, A98B10115, A98B12095
b) 4R2256, lots A97L26070, A97L27086, A97L29082,
A97L29108, A97L30098, A98A12089, A98A12105,
A98A12170, A98A13046, A98A13095, A98A19084,
A98A19092, A98A20082, A98A20090, A98A22062,
A98A22138, A98A24068, A98A27079, A98A27103,
A98A29109, A98A30065, A98A30073, A98A31071,
A98B03078
c) 4R2250, lots A98A23060, A98A28069, A98B02054
d) D4R2251, lot A97L29041
e) R4R2252, lots A97L26088, A98A28119, A98A28127,
A98A29083
f) 4R2262, lots A98A22120, A98A26071, A98A28077,
A98A29067; D4R2262, lots A98A29059, A98B06071
g) 4R2264, lot A98B04068
h) E4R2266, lot A98A08079, A98A09077, A98A12071,
A98A12097, A98A13111, A98A14085, A98A15090,
A98B09083
I) D4R2278, lot A97L27045; R4R2278, lots
A97L22046, A97L26054, A98A22047, A98A29075,
A98A31048
j) J4R2252, lots A98A14069, A98A16031, A98A19076,
A98A21098, A98A22088, A98A23086, A98A24076,
A98B03086, A98B04084; J4R2253, lots A98A27061,
A98B02062
k) J4R2283, lot A97L29090; J4R2284, lot A97L30080.
MANUFACTURER Baxter S.A. Fenwal Division, Parque Industrial
Itabo, Zona Franca Industrial de Haina, San
Cristobal, Republica Dominicana
RECALLED BY Baxter Healthcare Corporation, Biotech
Group/Fenwal Division, Deerfield, Illinois, by
letter dated March 3, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 913,269 sets were distributed in the U.S., 75,382
sets were distributed in Europe, and 11,184 sets
were distributed in Japan, with the firm
estimating that 1,000,000 sets remain on the
market.
REASON Manufacturing deviations in the diameter of the
anticoagulant line tubing of the Plasmacell-C
Disposable sets which cause an increase in
anticoagulant flow rate may result in the
potential for donor air embolus.
_______________
PRODUCT Source Plasma. Recall #B-782-8.
CODE Unit numbers: 1551AX and 1725AX.
MANUFACTURER Bloomington Plasma, Inc., Bloomington, Illinois.
RECALLED BY Manufacturer, by fax on February 9, 1998.
Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 2 units were distributed.
REASON Blood product was collected from an unsuitable
donor.
_______________
PRODUCT Platelets, Pheresis. Recall #B-783-8.
CODE Unit #C99066.
MANUFACTURER Regional Health Resources Center, Community Blood
Services of Illinois, Urbana, Illinois.
RECALLED BY Manufacturer, by telephone on January 5, 1997, and
by letter dated January 19, 1998. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.
_______________
PRODUCT Recovered Plasma. Recall #B-784-8.
CODE Unit numbers: 40FG12263, 40FG14323, 40FG13784.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, on October 24, 1997. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 3 units were distributed.
REASON Blood products tested negative for the antibody to
the human immunodeficiency virus type 1 (HIV-1),
but were collected from a donor who previously
tested repeatedly reactive for the antibody, and
was subjected to additional retesting.
_______________
PRODUCT Red Blood Cells. Recall #B-785-8.
CODE Unit #38FC30422.
MANUFACTURER American Red Cross Great Lakes Region, Fort Wayne,
Indiana.
RECALLED BY Manufacturer, by telephone on January 12, 1998.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for CMV but was
collected from a donor who previously tested CMV
positive.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-819/821-8.
CODE Unit numbers: a) KG24037, KN46753
b) KG24037, KN46753; c) KN46753.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated March 9, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Louisiana and Virginia.
QUANTITY a) 2 units; b) 2 units; c) 1 unit was distributed.
REASON Blood products tested non-reactive for the
antibody to the Hepatitis B core antigen
(anti-HBc), but were collected from a donor who
was previously repeatedly reactive for anti-HBc on
two separate donations.
_______________
PRODUCT Source Leukocytes for Further Manufacture.
Recall #B-822-8.
CODE Unit #3226920.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY Manufacturer, by telephone and fax on September
30, 1997. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
previously tested PKTP repeat reactive and MHA-TP
positive, RPR nonreactive for syphilis.
_______________
PRODUCT Red Blood Cells. Recall #B-823-8.
CODE Unit #40GN68651.
MANUFACTURER American Red Cross, Heart of America Region,
Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated February 19, 1998.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who lived
in a malarial endemic area.
_______________
PRODUCT Red Blood Cells. Recall #B-824-8.
CODE Unit #40LH13022.
MANUFACTURER American Red Cross, Heart of America Region,
Peoria, Illinois.
RECALLED BY Manufacturer, by letter dated March 5, 1998.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who lived
in a malarial endemic area.
_______________
PRODUCT Platelets. Recall #B-841-8.
CODE Unit #18E96029.
MANUFACTURER American Red Cross, Great Lakes Region, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter on May 6, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of clotted
Red Blood Cells.
_______________
PRODUCT Platelets. Recall #B-842-8.
CODE Unit #L69635.
MANUFACTURER South Bend Medical Foundation, South Bend,
Indiana.
RECALLED BY Manufacturer, by telephone on November 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-858/859-8.
CODE Unit numbers: a) 38FC27919; b) 38P47427,
38P47503.
MANUFACTURER American Red Cross Great Lakes Regional, Fort
Wayne, Indiana.
RECALLED BY Manufacturer, by letter dated September 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Alabama, Indiana, Ohio.
QUANTITY a) 1 unit; b) 2 units were distributed.
REASON Blood products tested negative for CMV, but were
collected from a donor who previously tested CMV
positive.
_______________
PRODUCT Red Blood Cells. Recall #B-866-8.
CODE Unit #29FL48234.
MANUFACTURER The American Red Cross, Mid-Atlantic Region,
Norfolk, Virginia.
RECALLED BY Manufacturer, by letter dated January 12, 1998.
Firm-initiated recall complete.
DISTRIBUTION Virginia and Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitate AHF;
c) Plasma, Cryoreduced; d) Recovered Plasma,
Frozen. Recall #B-872/875-8.
CODE Unit numbers: a) 29GT81176, 29GT65483, 29GT59170;
b) 29GT59170; c) 29GT59170
d) 29GT81176, 29GT65483.
MANUFACTURER The American Red Cross, Norfolk, Virginia.
RECALLED BY Manufacturer, by letter dated February 24, 1998.
Firm-initiated recall complete.
DISTRIBUTION California, North Carolina, Virginia.
QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 2 units were
distributed.
REASON Blood products were collected from a donor with a
history of cancer.
_______________
UPDATE Recovered Plasma, Unit #13FJ26037, should have
been listed in the April 8, 1998, Enforcement
Report as Recall #B-853-8.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Whole Blood for Reagent Use. Recall #B-710-8.
CODE Unit #3044.
MANUFACTURER Blood and Plasma Research, Inc., Beaumont, Texas.
RECALLED BY Manufacturer, by telephone and by letter dated
December 11, 1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was tested for the HIV-1 p24 antigen
using a sample that remained at an unmonitored
temperature for an unknown period of time during
shipment.
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-765-8.
CODE Unit #40FL17972.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on November 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole
Blood with an extended collection time.
_______________
PRODUCT Red Blood Cells. Recall #B-817-8.
CODE Unit numbers: 39Z20468, 39E26713, 39F63596,
39E26727.
MANUFACTURER American Red Cross Blood Services, Huntington,
West Virginia.
RECALLED BY Manufacturer, by telephone on January 23, 1998.
Firm-initiated recall complete.
DISTRIBUTION West Virginia.
QUANTITY 4 units were distributed.
REASON Blood products, for which the temperature at the
time of receipt was not documented
_______________
PRODUCT Recovered Plasma, for Manufacture of
Non-Injectables. Recall #B-867-8.
CODE Unit #29FL48234.
MANUFACTURER The American Red Cross, Norfolk, Virginia.
RECALLED BY Manufacturer, by letters dated January 12, 1998,
and February 11, 1998. Firm-initiated recall
complete.
DISTRIBUTION Virginia and Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a
history of cancer.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT HPC-93 Collimator component of the Head of a Gamma
Camera. The collimator itself is a heavy metal
barrier with fixed holes. It is designed to allow
only the gamma radiation from the part of the body
being examined to reach the gamma camera and acts
as a nuclear lenses. The collimators also provide
thermal and physical protection for the
scintillation crystals of the gamma camera.
Recall #Z-486-8.
CODE Various non-sequential serial numbers and tag
I.D.'s.
MANUFACTURER Elscint, Ltd., Advanced Technology Center, Haifa,
Israel.
RECALLED BY Elscint, Inc., Hackensack, New Jersey, by
telephone on October 21, 1996, followed by letter
on October 29, 1996. Firm-initiated field
correction complete.
DISTRIBUTION Nationwide.
QUANTITY 54 units were distributed.
REASON The collimator fell off the head of a gamma camera
onto the floor, possibly due to improper
installation or design flaw.
_______________
PRODUCT Series II Tibial Bearing Insert 15 mm Thickness,
Size 5, implantable plastic accessory to a knee
system.
Recall #Z-487-8.
CODE Catalog #3052-0515, Lot #17586801.
MANUFACTURER Osteonics Corporation, Allendale, New Jersey.
RECALLED BY Manufacturer, by telephone on February 14, 1997,
followed by letter on February 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION Minnesota, Iowa, Florida, Massachusetts, Japan.
QUANTITY 8 units were distributed.
REASON The product was designed to be 15mm in thickness,
however, it was incorrectly finished with a 12mm
thickness and then labeled as 15mm. The results
of this manufacturing error is a dislocation of
the tibial insert with the potential for
restriction in flexing motion of the knee.
_______________
PRODUCT Acclaim Infusion Pump, used to deliver parenteral
infusion including whole blood, red blood cell
components and enteral fluids using a wide variety
of standard administration sets and fluid
containers.. Recall #Z-498-8.
CODE List No. 12032-04, all serial numbers.
MANUFACTURER Abbott Laboratories, Critical Care Products,
Morgan Hill, California.
RECALLED BY Manufacturer, by letter dated March 30, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Florida, Maine, Mississippi,
New Hampshire, North Carolina, Oklahoma, Rhode
Island.
QUANTITY 2,343 units were distributed.
REASON Incorrect tubing setups which could lead to
underinfusions.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Trypic Soy Agar Media Plates, recommended for use
in qualitative procedures for the isolation and
cultivation of a wide variety of organisms.
Recall #Z-488-8.
CODE Product #01-924, Lot 5550 EXP 11/13/96.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on or about October 4,
1996. Firm-initiated recall complete.
DISTRIBUTION Iowa and Colorado.
QUANTITY 800 units were distributed.
REASON The device does not support the growth of
challenge organisms.
_______________
PRODUCT N/F System (42P tube, GNF tube, Uni-N/F-Tek
plate), a Nonfermenter System intended for the
simple and rapid presumptive identification of the
most frequently encountered clinical isolates of
gram-negative aerobic bacteria which do not belong
to the family Enterobacteriaceae (ie, the "other
gram-negatives."). Recall #Z-492-8.
CODE Product No. 73-10055, Lot No. 5513.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on November 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Washington State, New Jersey, New York,
California, Louisiana.
QUANTITY 17 boxes 920 units per box) were distributed.
REASON The correct color could not be obtained for a
positive reaction.
_______________
PRODUCT Vogel-Johnson Agar, a plated medium recommended
for use in qualitative procedures for the early
detection of coagulase-positive and
mannitol-fermenting strains of Staphylococcus
aureus from contaminated foods and clinical
specimens. Recall #Z-493-8.
CODE Product #01-970, Lot #5571 EXP 05/19/97, Segment
#4.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on March 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 90 units were distributed.
REASON The media did not support growth and this lot did
not meet its release criteria.
_______________
PRODUCT Roche Online Amphetamine Kits, an in-vitro
diagnostic test for the qualitative and
semi-quantitative detection of amphetamine and
methamphetamine and their metabolites in human
urine: a) Order #43430; b) Order #43564. Recall
#Z-494/495-8.
CODE Lot numbers: a) 30247 EXP 12/97 and 24017 EXP
12/97; b) 56467 EXP 12/97 and 46017 EXP 12/97.
MANUFACTURER Roche diagnostic Systems, Belleville, New Jersey.
RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey
(responsible firm), by letter on July 10, 1997,
followed by telephone. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY a) 1,097 kits of lot 30247 and 303 kits of lot
24017; b) 643 kits of lot 56467 and 54 kits of lot
46017 were distributed. Firm estimates none
remains on the market.
REASON The reagents did not meet performance criteria
throughout their assigned expiration date.
_______________
PRODUCT Roche Creatinine Reagent, in-vitro diagnostic
reagent system intended for use in the
quantitative determination of creatinine serum,
plasma and urine. Recall #Z-496-8.
CODE Order No. 47003, Lot No. 00356 EXP 9/10/98.
MANUFACTURER Roche Diagnostic Systems, Belleville, New Jersey.
RECALLED BY Roche Diagnostic Systems, Somerville, New Jersey,
by letter on May 13, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,733 kits were distributed; firm estimates none
remains on the market.
REASON The device has shown reduced reagent stability.
END OF ENFORCEMENT REPORT FOR APRIL 15, 1998. BLANK PAGS MAY
FOLLOW.
End of Enforcement Report for
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