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
09/24/1991
Enforcement Report for 8/25/91
September 25, 1991
Recalls and Field Corrections:
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
NONE
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
Product: Frozen yeast raised donut dough products sold in bulk
containers:
(a) Ring Donuts, item #S-1: 26 lbs, 276 count box,
item #S-1S: 13.5 lbs, 120 count box;
(b) Cinnamon Pershing Donuts; item #S-2S: 15 lbs, 120
count box, item #F-2S: 19.5 lbs, 156 count box;
(c) Bars - Long Johns; item #S-3S: 12.5 lbs, 120 count box,
item F-35: 17.5 lbs, 168 count box;
-1-
(d) Bismarks; item #S-5S: 12.5 lbs., 120 count box,
item #F5S: 17.5 lbs, 168 count box;
(e) Texas and Mini Donut; item #S-6S: 15.75 lbs,
60 count box, item #F-6S: 16.8 lbs, 72 count box;
(f) Cinnamon Strip Donuts; item #S-10: 12.45 lbs,
120 count box;
(g) Nut Roll Donuts; item #S-11S; 15 lbs, 120 count box;
item F-11S: 19.5 lbs, 156 count box;
(h) Bear Claw Donuts; item #S-13S: 15 lbs, 120 count box,
item #F-13S: 19.5 lbs, 156 count box;
(i) Apple Fritters; item #S-16: 22.5 lbs, 120 count box;
(j) Cherry Fritters; item #S-17: 22.5 lbs, 120 count box;
(k) Donut Cubes; item #D-13S: 18.75 lbs, 1440 count box.
Recall #F-530/540-1.
Code: Lot numbers 7-10-* through 7-36-* and 8-1-* through
8-17-* where * is either a "1" or "2" indicating the shift.
Products manufactured between 7-10-91 and 8-9-91 and have
expiration dates stamped on the cases which vary with each
customer, but would be within 3 months of the manufacturing
date.
Manufacturer: Freezeway, Inc., Urbana, Illinois.
Recalled by: Pappy's Inc., Maple Grove, Minnesota, by telephone
August 20, 1991. Firm-initiated recall ongoing.
Distribution: Illinois, Iowa, Indiana, Ohio.
Quantity: 15,042 cases were distributed; firm estimates 5 percent
remains on the market.
Reason: Product contains undeclared FD&C Yellow No. 5.
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Product: Pak-O-Hind sweets made with milk:
(a) White and Pink Chum Chum;
(b) Multi-Layered, Yellow, Pistachio and Cashew Burfi;
(c) Rasgulla; (d) Rasmali; (e) Kalakand, Jamun.
Recall #F-543/548-1.
Code: None.
Manufacturer: Sheereen Mahal Ltd., Jackson Heights, New York.
Recalled by: Manufacturer, by visit July 1, 1991. Firm-initiated
recall ongoing.
Distribution: New York, New Jersey, Maryland.
Quantity: Unknown.
Reason: Products are contaminated with Staphylococcus aureus and
Staphylococcus enterotoxin.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Bernstein's 96% Saturated Fat Free Herb & Garlic Italian
Creamy Dressing, in 16 fluid ounce jars. Recall #F-541-1.
-2-
Code: Lot #OCT0191.
Manufacturer: Nalley's Fine Foods, Tacoma, Washington.
Recalled by: Manufacturer, by memorandum June 21, 1991, followed
by visit. Firm-initiated recall ongoing.
Distribution: Washington state, Oregon, California, Utah, Alaska,
Arizona.
Quantity: 5,574 cases (6 jars/case) were distributed.
Reason: Product is contaminated with yeast.
----
Product: Quaker Quick Creamy Wheat Enriched Farina, for food
service use, in 28 ounce boxes. Recall #F-542-1.
Code: Lot numbers: 1L08G and 1L09G. Case codes: July 8,
1991 and July 9, 1991.
Manufacturer: The Quaker Oats Company, Cedar Rapids, Iowa.
Recalled by: The Quaker Oats Company, Chicago, Illinois, by
telephone August 16, 1991 followed by letter
August 19, 1991. Firm-initiated recall ongoing.
Distribution: Maryland, Pennsylvania, New York, Massachusetts,
Connecticut, New Jersey, Illinois.
Quantity: 1,890 cases (12 boxes/case) were distributed; firm
estimates 75 percent remains on the market.
Reason: Product contains small pieces of cast steel.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: AK-CON-A, in 15 ml bottles, a Rx ophthalmic antihistamine
decongestant. Recall #D-643-1.
Code: Lot #19118 EXP 4/93.
Manufacturer: Walnut Pharmaceuticals, Inc., Los Angeles, California.
Recalled by: Walnut Pharmaceuticals, Inc., Anaheim, California, by
letter August 9, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and Puerto Rico.
Quantity: 19,957 bottles were distributed.
Reason: Reports that product caused transient burning and stinging.
----
Product: Recovered Plasma. Recall #B-404-1.
Code: Unit #00504.
-3-
Manufacturer: Ephrata Community Hospital, Ephrata, Pennsylvania.
Recalled by: Manufacturer, by letter May 16 and 24, 1991. Firm-
initiated recall ongoing.
Distribution: Pennsylvania, California.
Quantity: 1 unit.
Reason: Blood product, which tested initially reactive for the
hepatitis B surface antigen (HBsAg) and was not retested
in duplicate, was distributed.
----
Class III -
Product Cefizox Viaflex Plus (Sterile Ceftizoxime Sodium), in
50 ml single dose plastic containers, a Rx semisynthetic,
broad-spectrum, beta-lactamase resistant cephalosporin
antibiotic for parenteral administraiton:
(a) 1 gram Ceftizoxime Sodium in 5% dextrose;
(b) 2 grams Ceftizoxime Sodium in 5% Dextrose.
Recall #D-644/645-1.
Code: Item Numbers Lot numbers
(a) 2B3514 LD027599, LD028381, LD028720, LD029314,
LD030023, LD030213, LD030973;
(b) 2B3515 LD027581, LD029358, LD030940.
Manufacturer: Baxter Healthcare Corporation, Round Lake, Illinois.
Recalled by: Fujisawa Pharmaceutical Company, Division of Fujisawa
USA, Inc., Deerfield, Illinois, by letter August 28, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 9,107 cases (24 bags per case); (b) 3,109 cases
(24 bags per case) were distributed;
firm estimates 30% of the product remains on the market.
Reason: The package insert contains a printing error under the
dosage and administration section.
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Product: (a) Whole Blood; (b) Red Blood Cells;
(c) Red Blood Cells, Leukocytes Removed;
(d) Red Blood Cells, Frozen; (e) Platelets;
(f) Platelets, Pheresis; (g) Granulocytes.
(h) Cryoprecipitated AHF; (i) Fresh Frozen Plasma;
(j) Single Donor Plasma; (k) Recovered Plasma.
Recall #B-387/397-1.
Code: All units collected between January 18, 1991 and
February 1, 1991.
Manufacturer: Louisiana Blood Center, Shreveport, Louisiana and
Blood Center of Southeast Texas, Beaumont, Texas.
Recalled by: Louisiana Blood Center, Shreveport, Louisiana, by
telephone and visit February 3, 1991 followed by
letter February 6, 1991 (Louisiana), and February 19,
1991 (Texas). Firm-initiated recall complete.
Distribution: Louisiana, Texas.
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Quantity: (a) 62 units; (b) 2,450 units; (c) 10 units;
(d) 24 units; (e) 724 units; (f) 62 units;
(g) 1 unit; (h) 14 units; (i) 209 units;
(j) 3 units; (k) 1,005 units.
Reason: Blood products, incorrectly tested for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1)
and the antibody to the hepatitis C virus (anti-HCV), were
distributed. All units also tested negative upon retesting.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Mandatory Recall -
Product: Medline/Dynacor Dynafeed Enteral Feeding Pump,
Models EP-100 and D70600, an electronically controlled,
motor driven feeding device for the administration of
nutritional supplemental formulas. Recall #Z-1049-1.
Code: All serial numbers.
Manufacturer: Sterling Medical Systems, Inc., West Valley City, Utah
and The Morey Corporation, Downers Grove, Illinois.
Recalled by: Medline Industries, Inc., Mundelein, Illinois, by
letter September 9, 1991. FDA-ordered recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 3,325 units were distributed.
Reason: Mandatory 518(e) recall. The device, when in use for its
intended purpose, may malfunction due to numerous design
defects. The pumps pose a high risk of serious adverse
health consequences or death due to the potential for
fatal electric shock to patient/operators, and the
potential for inaccurate or over- and under-infusion.
----
Class I -
Product: Coaxial bipolar endocardial pacemaker leads, implantable
electrodes used to connect a pulse generator to the
heart:
(a) Model 1016T (52 mm and 60 mm), in-line, silicone,
finned with activated carbon electrode;
(b) Model 1026T (60 mm), in-line, silicone, tined with
activated carbon electrode. Recall #Z-966/967-1.
Code: All serial numbers.
Manufacturer: Pacesetter Systems, Inc., Sylmar, California.
Recalled by: Manufacturer, by letter July 8, 1991, followed by visit.
Firm-initiated recall ongoing.
Distribution: Nationwide and Guam.
Quantity: (a) 23,968 units; (b) 7,799 units were distributed.
-5-
Reason: A potential failure mechanism can result in a breach in the
inner insulator of the above coaxial bipolar leads. This
result in an internal short-circuit between the inner and
outer conductor coils, causing pauses in pacing operation
and failure to sense and/or pace.
----
Class II -
Product: Size 7 French Marathon Guide Catheters.
Recall #Z-882-1.
Code: Model numbers: 76-652-7F, 76-158M-7F, 76-457S-7F,
76-456M-7F, 76-157S-7F, 76-157M-7F, 76-457M-7F,
76-SP157-7F, 76-660X-7F, 76-456S-7F, 76-158S-7F,
76-ST158-7F.
Manufacturer: Baxter Healthcare Corporation, Edwards Lis Division, Irvine,
California.
Recalled by: Manufacturer, by visit March 13, 1991. Firm-initiated
recall ongoing.
Distribution: Alabama, Arizona, Georgia, Michigan, Minnesota, North
Carolina, New Jersey, Ohio, Pennsylvania, Wisconsin.
Quantity: 739 were distributed.
Reason: There may be an exposed wire near the distal tip of the
catheter at the primary curve which could cause damage to
the internal lining of the vessel and/or perforation.
----
Product: Preview Strep A In-vitro EIA-type Diagnostic Test Kit
for the detection of Streptococcus A from throat swabs,
in kits of 4, 25 or 50 tests. Recall #Z-951-1.
Code: Kit lot numbers: 43088 EXP 12/17/91, 43088A EXP 12/17/91.
Manufacturer: Leeco Diagnostics, Inc., Southfield, Michigan.
Recalled by: Manufacturer, by telephone March 1991 and by
memorandums of August 1 and 5, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Switzerland, Italy, Sweden.
Quantity: 359 25-test and 200 4-test, test kits of lot 43088
and 300 50-test and 503 25-test, test kits of lot
43088A were distributed.
Reason: The product performance may lead to inaccurate test
results.
----
Product: Shibuya Silas Series CO2 Laser Cutting Machines.
Recall #Z-952-1.
Code: Series CO2.
Manufacturer: Utilase Systems, Inc., Detroit, Michigan.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan August 7, 1991. Firm-initiated field
correction ongoing.
Distribution: Michigan, North Carolina.
-6-
Quantity: 4 units were distributed.
Reason: Noncompliance with the performance standard for laser
products in that they lacked adequate protective housing
to prevent unnecessary operator human access to laser
radiation. The user manual also failed to adequately define
the hazardous areas surrounding the machines. The
descriptive sales brochures lacked a reproduction of the
required warning logotype label.
----
Product: Medtronic Model 9760 Programmers with model numbers
9852 and 9853 software:
(a) Model 9852 Software for the Medtronic Model 9760
Programmer to program the Elite pacemakers;
(b) Model 9853 Software for the Medtronic Model 9760
Programmer to program the Legend II Series pacemakers.
Recall #Z-955/956-1.
Code: All Model 9760 units used with Models 9852 and 9853
software.
Manufacturer: Medtronic, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by letter July 24, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Australia, Canada, Japan, Mexico,
The Netherlands.
Quantity: 1,273 units were distributed.
Reason: During a continuous auto-threshold test, there may
be a continuous decreasing of the temporary pulse width
value after the program button is released rather than
termination of the test as designed, due to a software
performance problem with the Model 9852 and 9853 Software.
----
Product: Micropump Dual Rate Programmer Model 2510, Catalog
numbers 8810320 and 8810309, may also be known as the
Parker Micropump or the Abbott Lifecare. Product was
designed to be used with the Model 2100 Micropump Infuser
intended for use with drugs that are suitable for continuous
ambulatory infusion. Recall #Z-1017-1.
Code: All serial numbers.
Manufacturer: Parker Hannifin Corporation, Irvine, California.
Recalled by: Strato Medical Corporation, Pfizer Hospital Products
Groups, Inc., Beverly, Massachusetts, by telephone
and by letter July 1, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 36 units were distributed.
Reason: Product was marketed without an approved 510(k).
----
-7-
Product: Mansfield/Webster Polaris Special Electrode Catheter
with special order numbers 571003, 571004, 571010, 571015,
571021, 571022, intracardiac electrophysiology electrode
catheter, non sterile, for single use only.
Recall #Z-1025/1030-1.
Code: All lots.
Manufacturer: Webster Laboratories, Inc., Baldwin Park, California.
Recalled by: Manufacturer, by letter March 22, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,227 units were distributed; firm estimates little
product remains on the market.
Reason: The tip electrode may overheat and separate from
the catheter.
----
Product: Sterile Disposable Electrosurgical Pencil Model 7550-6P
Neoknife. Recall #Z-1033-1.
Code: Catalog #33-1505. All lots 9006-1985, 9007-1985, 9007-1989,
9011-2005.
Manufacturer: Birtcher Medical Systems, Irvine, California.
Recalled by: Manufacturer, by telephone followed by letter on
March 15, 1990 and/or April 19, 1990. Firm-initiated
recall complete.
Distribution: California, Florida, Illinois, Kansas, Indiana,
New Jersey, Massachusetts, Ohio, Pennsylvania,
South Carolina, Virginia, Canada, India.
Quantity: 14,610 units were distributed; firm estimates none
remains on the market.
Reason: Some of the pencils will not deliver output to the electrode
due to the possibility that the electrode chuck inside the
handle can become unsoldered from its printed circuit board.
----
Product: (a) XR/T Collimator Shelf and Crane;
(b) XC/T Collimator Shelf and Crane ("Collimator Stackers")
for Starcam 3000XCT, Starcam 4000XCT, Starcam 3200XRT,
Starcam 3000XRT, Starcam 4000XRT, Camstar XCT and Camstar
XRT nuclear medicine systems. Products are
used for handling, lifting and moving heavy lead
collimators used with the nuclear medicine systems.
Recall #Z-1046/1047-1.
Code: All XC/T Stacker units, 46-300114G1 and all XR/T
Stacker units, 46-300113G1, manufactured prior to
May 1, 1991.
Manufacturer: IGE Medical Systems, Ltd., St. Albans Herts,
United Kingdom.
Recalled by: GE Medical Systems, Waukesha, Wisconsin, by letter
March 11, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: (a) 121; (b) 143 units were distributed.
-8-
Reason: The collimator trays can be pulled free of the stackers
because of a weakness in the end stops on the shelf
slides of the stackers. If a shelf is pulled past the
end stops, the shelf and the collimator on the shelf
can fall before the collimator is secured to the crane.
----
Product: Preview Urine hCG In-vitro Diagnostic Pregnancy Kit,
consisting of enough reagents to complete either 4,
25, or 50 tests. Recall #Z-1048-1.
Code: Lot #44093C EXP 2/29/92.
Manufacturer: Leeco Diagnostics, Inc., Southfield, Michigan.
Recalled by: Manufacturer, by telephone between February 20 and 27,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide and Greece.
Quantity: 92 kits were distributed; firm estimates none remains
on the market.
Reason: The product performance may lead to inaccurate test
results.
----
Product: ACS Indeflator, Catalog #24300, used with balloon
dilitation catheters for percutaneous transluminal
angioplasty to monitor pressure created in the balloon.
Recall #Z-1050-1.
Code: Lot numbers: 1020651, 1022551, 1030551, 1031451, 1031452,
1031453, 1031551, 1041151, 1041152, 1041153, 1042651,
1042652, 1042653, 1050952, 1050954, 1051052.
Manufacturer: Advanced Cardiovascular Systems, Inc., Temecula, California.
Recalled by: Manufacturer, by letter May 31, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,874 units were distributed; FDA estimates little
product remains on the market.
Reason: The plastic fitting that connects the tubing to the
indeflator may break or leak, due to brittleness.
----
Product: Impra brand Thinwall Expanded Polytetrafluoroethyene (PTFE)
Vascular Grafts, 10 cm x 3 cm, indicated for use in
bypass or reconstruction of occluded or diseased arterial
blood vessels. Recall #Z-1052-1.
Code: Catalog #10S03TW, Lot #14961-OG EXP 11/95.
Manufacturer: Impra, Inc., Phoenix, Arizona.
Recalled by: Manufacturer, by telephone June 21, 1991, followed by
letter June 24, 1991. Firm-initiated recall complete.
Distribution: Georgia, Louisiana.
Quantity: 5 boxes (2 units per box) were distributed; firm
estimates none remains on the market.
-9-
Reason: Packaging error. The package has the internal diameter
of the graft labeled as "6mm"; the correct size is 3 mm.
----
Product: Femoral Proximal Guides, used to guide an intramedullary
rod into the femur:
(a) Small, Product #2237-09;
(b) Large, Product #2237-10. Recall #Z-1055/1056-1.
Code: Lot numbers: (a) 73708200, 75481800;
(b) 73708300, 73852500, 75481900.
Manufacturer: Zimmer, Inc., Warsaw, Indiana.
Recalled by: Manufacturer, by telephone and letter July 9, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 34 pieces; (b) 43 pieces were distributed.
Reason: The alignment arrow was placed on the wrong side of
the barrel which may cause improper positioning of the
intramedullary rod.
----
Product: ConFirm Biological Sterilization Indicator System Test
Strips, indicated for use in determining efficiency of
steam, dry heat, or EO sterilization.
Recall #Z-1057/1065. (This recall is an extension of
Z-895/896-1 which appeared in the August 1, 1991
Enforcement Report):
(a) DRI - Dental Research Institute School of Dentistry,
University of Minnesota Biological Sterilization
Indicator System, Reorder No. DRI010 (1 test set);
(b) Sterilizer Testing Service, Oral Pathology
Diagnostic Service School of Dentistry, Medical College
of Virginia Biological Sterilization Indicator System,
Reorder No. MCV010 (1 test set);
(c) M - Dental School, University of Michigan Biological
Sterilization Indicator System, Reorder No. UMI010
(1 test set);
(d) P&S - University of Pacific, School of Dentistry
Biological Sterilization Indicator System,
Reorder #UOP010 (1 test set);
(e) University of Detroit School of Dentistry Biological
Sterilization Indicator System, Reorder No. UDT010
(1 test set);
(f) Biological Monitoring System, Smart Practice
Biological Sterilization Indicator System,
Reorder No. SMP010;
(g) USC - Sterilizer Monitoring Service, School of
Dentistry, University of Southern California Biological
Sterilization Indicator System, Reorder No. USC010
(1 test set);
(h) The Alumni Association, University of Texas Health
Science Center Biological Sterilization Indicator
System, Reorder No. UTX010 (1 test set);
-10-
(i) UF Sterilization Monitoring and Consultation
Service Biological Sterilization Indicator System,
Reorder No. UFL010 (1 test set). Recall #Z-1057/1065-1.
Code: All lots distributed in 1989 and 1990. Product has
2 year expiration. Reorder No. CST010 (1 test set)
and Reorder No. CST060 (6 test sets).
Manufacturer: Cottrell, Ltd., Englewood, Colorado.
Recalled by: Manufacturer, by letters of July 24, 1991 and August 7,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 3,348 units were distributed.
Reason: The affected test strips are indicated for use as a
biological indicator in monitoring the unsaturated
chemical vapor (chemiclave) sterilization process without
510(k) approval for this specific application.
----
Product: APS II Model 3003 Programmer with Model 3036 Software
function pack, a pacemaker generator function analyzer
and programmer which is connected to a pacemaker pulse
generator with telemetry for testing and programming any
or all of the pulse generator's parameters.
Recall #Z-1066-1.
Code: All serial numbers.
Manufacturer: Siemen Pacesetter Systems, Inc., Sylmar, California.
Recalled by: Manufacturer, by letter April 15, 1991. Firm-initiated
filed correction ongoing.
Distribution: Nationwide.
Quantity: 2,255 units were distributed.
Reason: Unexpected rate scans can be initiated during the rate
programming of DIALOG II and SENSOLOG III due to
software problems.
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Product: (a) Low Prime Membrane Blood Oxygenator ("Univox");
(b) Low Prime Membrane Blood Oxygenator with Integrated
Cardiotomy ("Univox I.C."). Recall #Z-1068/1069-1.
Code: Serial numbers range from 307248 to 336205.
Lot numbers:
(a) AOE1802, AOE1083, AOE1804, A0E1805, A0E2901, AOE2902
AOE2903, AOE2904, AOE2905, A0F0601, AOF0602, AOF0603
AOF1901, AOF1902 AOF1903, A0F1904, AOF1905, AOG0204
AOG0205, AOG1601, AOG1603, AOG1604, A0G1605, AOG1902
AOG1903, AOH2202, AOH2205, AOH2302, A0H2201, AOJ1202
AOH2305, AOJ0601, AOJ0603, AOJ0604, AOJ1201, AOJ1203
AOJ1204, AOJ1205, AOJ1301, A0K2302, AOK1202, AOK1203
AOK1204, AOK2305, AOK2304, A0K2303, AOK1206, A1A2502
AOL0202, AOH0806, AOH1702, A0H1703, AOH2306, AOH2307
AOL0204, AOL0203, AOL0208, A0L0209, AOL0210, AOL0201
A1A2504, A1B2002, A1B2003, A2B2004, AOH2203, AOH2204
A1B2001, PA1C1901, A1B1101P, A0L0207, AOL0205, AOL0206
AOK1205, AOK2301, A1A0903, ALA0903A, ALA2501, A1A2503P;
-11-
(b) AOH0805, AOH0802, A0H0803, AOH0804, A0J2311, AOH2312
A0H2313, A0H2315, AOH2316, AOJ1904, AOJ1905, AOJ1906,
A0J1906A, AOJ1907, AOJ1907A, AOJ1907AA, AOH1907BA, AOK0612
A0K0611, AOK0610, AOK0609, AOK0605, AOK0606, AOK0607,
A0K0608, A1B2903, AOL0701, AOL0704F, AOl2903, AOl0702A,
A0L0702B, AOl0702C, AOl0702D, AOL0702E, AOL0703, AOL0703A
A0L0703B, AOL0703C, AOL0704, AOL0704A, AOL0704B, AOL0704C
A0l0704D, AOL0704E, AOL2902A, AOL2902B, AOL2902C, AOL2902D
A0L2902E, AOL2902F, AOM0501, A1A0902, A1B0401, A1B1803
A1B1803A, A1B0403, A1B0403A, A1B0402, A0J1905, A0J1907B
A0J1907A, A0K0701, A0K0702, A0L0702, A060704A, A0L0704F
A0L2902, A0L2903A, A0L2903B, A0L2903D, A0L2903F, A0M0501A
A0L2903C, A0L2903E, A1A0901A, A1A0901B, A1A0901, A1A0902A
AlA0902B, A0M0501A, A0M0501B, A0M0501C, A0M0501D, A0M0510C
AOM0501E, AOM0502A, A0M00502B, A0M0502D, A0M0502, AM0502C
A0M0502E, A1B0401M, A1B0401B, A1B0401A, A1B0402A, A1B0402
A1B0402B, A1B0403B, A1B0403, A1B0403C, A1B2903A, A1B2903
A1B2903B, PA1C2201, PA1C2201A, A0L2903BR, A0L2903AR, A9B0401
19B0401AR.
Manufacturer: Baxter Healthcare Corporation, Anasco, Puerto Rico.
Recalled by: Baxter Healthcare Corporation, Irvine, California, by
letter April 24, 1991. Firm-initiated recall complete.
Distribution: Nationwide and international.
Quantity: 10,338 units were distributed.
Reason: Defective gasket assembly and lack of bond integrity can
cause leakage, resulting in decreased oxygenation and
carbon dioxide removal.
----
Product: Arnett-TMP Depth Gauge, used to determine the screw
length to secure mandibular facial plates.
Recall #Z-1073-1.
Code: Lot #25962.
Manufacturer: George Tremann & Company, Plainview, New York.
Recalled by: Techmedica, Inc., Camarillo, California, by telephone
on or about January 15, 1991. Firm-initiated recall
ongoing.
Distribution: Minnesota, Ohio, Oregon, Washington state, Virginia,
Louisiana, South Africa, Korea, Australia, Canada.
Quantity: 24 units were distributed.
Reason: One of the dimensional measurements was incorrectly
measured. The 1.857 measurement for the distance to
the first placement of the calibrated groove is to
be measured from .060" from the tip. Instead it was
measured from the tip of the depth gauge causing the
7 calibrated grooves to be .060" off.
----
Product: Continum Knee System Tibial Insert, used on a CKS
tibial base plate for restoring ligamentous balance.
It is used as part of an implantable knee system.
Recall #Z-1074-1.
-12-
Code: #18113.
Manufacturer: Techmedica, Inc., Camarillo, California.
Recalled by: Manufacturer, by letter March 27, 1991. Firm-initiated
recall ongoing.
Distribution: Indiana, Ohio.
Quantity: 5 units were distributed.
Reason: The product is incorrectly labeled as "TIB INS #2/14 .5 mm"
whereas it should be labeled as "TIB INS #8-18mm."
----
Product: FC-700A Defibrillator, a battery operated unit which
contains an ECG monitor and recorder, and has a 360J
maximum discharge capacity. Recall #Z-1077-1.
Code: Serial numbers: 1607001 through 16070010, 16080011
through 16080015, 16090016, 17010028.
Manufacturer: Fukuda Denshi Company, Ltd., Tokyo, Japan.
Recalled by: Fukuda Denshi America Corporation, Redmond, Washington,
by letter June 5, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 17 units were distributed.
Reason: The time delay may not be within specifications. The
length of delay is intended by the firm to be 30 (ms)
to 50 (ms) with the upper limit of the delay specified
to be 60 (ms). Some units were noted to have upper
limits of 79.1 (ms) to 100.2 (ms).
----
Product: Ultra Shape Latex Condoms, packaged in vending machine
boxes. Recall #Z-1078-1.
Code: Lot #771.
Manufacturer: Aladan Corporation, Dothan, Alabama.
Recalled by: Barnetts, Inc., Charlotte, North Carolina, by telephone
July 19, 1991. Firm-initiated recall complete.
Distribution: Missouri, Nebraska, Pennsylvania, Tennessee.
Quantity: 212-1/2 gross were distributed.
Reason: The tested condoms have an Acceptable Quality Level (AQL)
in excess of 0.4%.
----
Product: Orthomet E-Mantle Acetabular Cups, Catalog #3670-xxxx,
where xxxx can be any of several four-digit numbers
designating the size of the cup. Product consists of a
metal shell and UHMWPE (plastic) liner which are components
of a hip prosthesis system. Recall #Z-1086-1.
Code: All lot numbers beginning with P88, P89, and P90, except
those lot numbers ending in S or Z.
Manufacturer: Orthomet, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by telephone beginning August 19, 1991.
Firm-initiated recall ongoing.
Distribution: Approximately 200 units were distributed.
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Reason: The gamma radiation used in sterilization causes shrinkage
of the UHMWPE liner which can result in a poor fit between
the UHMWPE liner and the metal shell.
----
Class III -
Product: Amerlite Cortisol Assay In-vitro Diagnostic Kit:
(a) Catalog #LAN.2801; (b) Catalog No. LAN.0801.
Recall #Z-1053/1054-1.
Code: Lot numbers 34 EXP 7/26/91, 35 EXP 8/20/91,
36 EXP 8/20/91, 37 EXP 1/10/92.
Manufacturer: Amersham Corporation, Arlington Heights, Illinois.
Recalled by: Manufacturer, by telephone August 8, 1991, followed
by letter August 12, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 150 kits were distributed, with 1 kit remaining
on the market.
Reason: The standards tray label listed the wrong valve for the
F standard, 63.7 mcg/dL instead of 58.1 mcg/dL.
----
Product: Arnett-TMP Malleable Miniplates, used for internal
fixation of maxillofacial, mandibular, and cranial
osteotonies and fractures: (a) Part #911-124, L Shaped;
(b) Part #911-142, T Shaped. Recall #Z-1075/1076-1.
Code: Lot numbers: (a) 25628; (b) 25544.
Manufacturer: Techmedica, Inc., Camarillo, California.
Recalled by: Manufacturer, by telephone on or about March 19, 1991.
Firm-initiated recall ongoing.
Distribution: (a) California, Georgia, Ohio, Texas, Wisconsin, Japan,
Turkey; (b) Minnesota, Turkey.
Quantity: 15 boxes were distributed.
Reason: The "L" shaped miniplates and the "T" shaped miniplates
were switched during packaging and thus mislabeled.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Neomycin Sulfate Oral or Topical Solution, 200 mg/ml, an
OTC product used for treatment of diarrhea and bacterial
enteritis in cattle, swine, sheep, horses, poultry and dogs,
under the Neovet brand, in 1 gallon plastic and 16 ounce
glass containers, and Neosul brand in 16 ounce glass
containers only (all with screw-on lids). Recall #V-089-1.
-14-
Code: All lots except 900847.
Manufacturer: Veterinary Laboratories, Lenexa, Kansas.
Recalled by: Rx Veterinary Products, Kansas City, Missouri, by
recall bulletins of August 20 and 27, 1991. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: Approximately 3,000 gallons of lot 900030 were distributed.
Amount of product distributed of the other lot numbers is
unknown.
Reason: A combination of Enterobacter and Klebsiella contamination
was found in the product.
----
Class III -
Product: Lutavit ELB E400, in 40 pound pails and in 440 pound
drums, an emulsifiable liquid blend of Vitamin E used
in animal feed. Recall #V-091-1.
Code: Lot #R01016102.
Manufacturer: Redex Industries, Salem, Ohio.
Recalled by: BASF Corporation, Chemical Division, Wyandotte, Michigan
by telephone February 4, 1991. Firm-initiated
recall complete.
Distribution: California, Colorado.
Quantity: 6,320 pounds were distributed; firm estimates none
remains on the market.
Reason: Subpotent in Vitamin E.
----
Medical Device Safety Alerts:
Product: Marquest Medical Heated Wire Anesthesia and Respiratory
Breathing Circuits to the Marquest SCT 2000 Heated
Humidifier, the Marquest SCT 3000 Heated Humidifier,
Marquest Neonatal, Pediatric, and Adult Heated Wire
Ventilator Circuits. Safety Alert #M-036-1.
Code: All lots; All serial numbers.
Manufacturer: Marquest Medical Products, Inc., Englewood, Colorado.
Alerted by: Manufacturer, by letter May 23, 1991.
Distribution: Nationwide and international.
Quantity: Approximately 4,800 of the SCT 2000, 2400 SCT 3000's and
100,000 Neonatal Ventilator Circuits were distributed.
The amounts of the Pediatric and Adult Ventilator
circuits have not been determined.
Reason: Potential for burn injury due to prolonged contact of
heated wire circuits with bare skin.
----
####
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