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
01/29/1992
Recalls and Field Corrections -- January 29, 1992
January 29, 1992 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: Candy, various labels and sizes:
1. Childrens Treat, Dairy Mart brand, in 4 ounce bags;
2. Candy Buttons, Dairy Mart brand, in 2 ounce bags;
3. Spice Drops, Dairy Mart brand, in 7 ounce bags;
4. Candy Roll, Dairy Mart brand, in 4 ounce bags;
5. Pixy Stix, Dairy Mart brand, in 2 ounce bags;
6. Old Mill Candies Salt Water Taffy, in 4 ounce bags;
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7. Assorted Fruit Slices, Dairy Mart brand, in 4 ounce bags;
8. Old Mill Candies Gum Drop Jellies, in 7 ounce bags;
9. Gourmet Jelly Beans, Dairy Mart brand, in 4 ounce bags;
10. Red Hot Dollars, dairy Mart brand, in 6 ounce bags;
11. Jujy Fruits, Dairy Mart brand, in 6 ounce bags;
12. Jelly Beans, Dairy Mart brand, in 7 ounce bags;
13. Olde Mill Candies JU JU Fish, in 5 ounce bags;
14. Bag O' Pops, Dairy Mart brand, in 5 ounce bags;
15. Jolly Rancher, Dairy Mart brand, in 4 ounce bags;
16. Atomic Fire Balls, Dairy Mart brand, in 4 ounce bags;
17. Wrapped Sour Balls, Dairy Mart brand, in 5 ounce bags.
Additional labels include Dairy Mart, Judy's Best, Olde Mill
Candies, Food Bag, and Nutmeg Candies. Not all types of
candies are distributed under each name brand.
Recall #F-093/109-2.
Code: None.
Manufacturer: John Hayes & Sons, Wolcott, Connecticut.
Recalled by: Manufacturer, by visit beginning December 30, 1991.
Firm-initiated field correction ongoing.
Distribution: New England, New York.
Quantity: Firm estimates very little product remained on the
market at the time of recall initiation.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Plaza Nacho Cheese Topping for Tortilla Chips in 9
ounce cans. Recall #F-113-2.
Code: All lots.
Manufacturer: Amigos Canning Company, Inc., San Antonio, Texas.
Recalled by: H.E.B. Food Stores, San Antonio, Texas, by telephone
April 3, 1991. Firm-initiated recall complete.
Distribution: Texas.
Quantity: None. 7,288 cans were recovered from the market and labeled
with a revised ingredient statement.
Reason: Product contains undeclared FD&C Yellow No. 5.
----
Product: Spring Water in 1 gallon clear plastic container with
snap on cap, under Polar Water and Crystal Spring Water
labels. Recall #F-110-2.
Code: All production on the market, however, they are
concentrating on the last 4 months because they believe
from market surveys that is all that remains.
Manufacturer: Polar Water Company, Division of Suntory Water Group,
Spring Grove, Virginia.
Recalled by: Suntory Water Group, Inc., Atlanta, Georgia, by letter
November 27, 1991, and by telephone November 26, 1991.
Distribution: Georgia, Pennsylvania, Virginia, Ohio, Tennessee.
Quantity: Approximately 28,194 1-gallon containers were distributed.
Reason: Product is contaminated with mold.
----
-2-
Product: Bottled Water, in 1.5 liter (50.7 fluid ounces) containers.
Recall #F-112-2.
Code: Lot #RM1036 08201.
Manufacturer: Cascade Clear Water Company, Sedro Wooley, Washington.
Recalled by: Talking Rain Beverages Company, Bellevue, Washington,
by visit. Firm-initiated recall complete.
Distribution: Washington state.
Quantity: 948 cases (12 containers/case) were distributed; firm
estimates none remains on the market.
Reason: Product has an off-taste.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Children's APAP Elixir, in 4 and 8 ounce sizes, a
liquid OTC, non-aspirin drug used for temporary relief
of fever and discomfort due to colds and flu, under the
Barre-National, Alba, Albertson, Besco, Janet Lee, Major
Quality Ty-Pap, Mutual, Peoples, Reliable, Revco, Rite Aid,
Rx Plus and Select brand. Recall #D-148-2.
Code: Lot numbers: Alba, 4 oz, grape 13585
Albertson, 4 oz., cherry 13069, 13414, 13584
Barre, 4 oz, grape 03323, 03786, 13585
Barre, 4 oz, cherry 03160, 03331, 03481, 03691, 13069
13137, 13278, 13414, 13584, 13694
Besco, 4 oz 02001
Janet Lee, 4 oz, cherry 13278
Major Quality Ty-Pap 4 oz, cherry, 03868, 13069
Mutual, 4 oz, cherry 13278
Peoples, 4 oz., cherry 03281
Reliable, 4 oz, grape 13071, 13279
Reliable, 4 oz, cherry 13137, 13278, 13584, 13694
Reliable, 8 oz, cherry 13069, 13137
Revco, 4 oz, grape 13585, 92370, 92594
-3-
Revco, 4 oz, cherry 03626, 13584, 92592, 92593
Revco, 8 oz, cherry 03691, 13584
Rite Aid, 4 oz, grape 03786, 13071, 13279, 13585
Rx Plus, 8 oz, cherry 13278, 13694,
Rx Plus, 4 oz, grape 13279
Select Brand, 4 oz, cherry 13694.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter December 23, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Mexico, Guam, Jamaica.
Quantity: 3,319,204 units were distributed; firm estimates 252,664
units remain on the market.
Reason: Markings on dosage cup are not totally compatible with
label dosage instructions.
----
Product: Various drug products:
(a) Allopurinol Tablets, 100 mg, in 100 and 1,000 tablet
bottles, 300 mg, in 100, 500 and 1,000 tablet bottles;
(b) Chlorothiazide Tablets, 500 mg, in 100 and 1,000
tablet bottles;
(c) Diazepam Tablets, 2 mg, 5 mg and 10 mg, in 100, 500
and 1,000 tablet bottles;
(d) Disopyramide Phosphate Capsules, 100 mg and 150 mg, in
100 and 500 capsule bottles;
(e) Doxepin HCl Capsules, 10 mg, 25 mg, and 50 mg, in
100 and 1,000 capsule bottles, 75 mg, in 100 and 500
capsule bottles; 100 mg, in 100 and 1,000 capsule bottles;
150 mg, in 100 capsule bottles;
(f) Ibuprofen Tablets, 200 mg in 60 and 100 tablet bottles;
400 mg, 600 mg, and 800 mg, in 100 500 and 1,000 tablet
bottles;
(g) Meclofenamate Sodium Capsules, 50 mg, in 100 and 250
capsule bottles; 100 mg, in 100, 250, and 500 capsule
bottles;
(h) Metronidazole Tablets, 250 mg, in 100, 250, and 500
tablet bottles; 500 mg, in 50 and 200 tablet bottles;
(i) Methyldopa Tablets, 125 mg, in 100 tablet bottles;
250 mg, in 100 and 1,000 tablet bottles; 500 mg, in
100 and 500 tablet bottles;
(j) Oxazepam Capsules, 10 and 30 mg, in 100 and 250
capsule bottles; 15 mg, in 100 and 500 capsule bottles;
(k) Perphenazine Tablets, 8 mg, in 100 and 250 tablet
bottles;
(l) Perphenazine/Amitriptyline HCl Tablets, 1/10,
2/25 and 4/25 mg, in 100 and 500 tablet bottles;
4/10, 4/50 mg, in 100 and 250 tablet bottles;
(m) Propoxyphene Napsylate/Acetaminophen Tablets,
50/325 mg, in 100 tablet bottles; 100/650 mg, in
100, 500 and 1,000 tablet bottles;
(n) Propranolol HCl Tablets, 20 and 40 mg, in 100, 500,
and 1,000 tablet bottles; 60 mg, in 100 tablet bottles;
80 mg, in 100 and 500 tablet bottles;
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(o) Thiothixene Tablets, 2, 5, and 10 mg, in 100 and 500
tablet bottles;
(p) Tolazamide Tablets, 100 mg, in 100 and 250 tablet
bottles; 250 mg, in 100, 250, and 500 tablet bottles;
500 mg, in 100 and 250 tablet bottles. All products are
packaged and labeled by Chelsea Laboratories for
distribution by Rugby Laboratories, with the exception
of the 200 mg Ibuprofen Tablets, UPS which bear
Rugby and Treasury Drug label. Recall #D-149/194-2.
Code: All lots.
Manufacturer: Chelsea Laboratories, Inc., Monroe, North Carolina.
Recalled by: Manufacturer, by letter November 1, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 30 percent of these products remain
on the market.
Reason: Lack of assurance of bioequivalency and Abbreviated
New Drug Approval discrepancies.
----
Product: Adonis Guar Gum Capsules, 530 mg, in 180 capsule bottles,
an OTC product. Recall #D-197-2.
Code: All lots.
Manufacturer: Universal Labs. New Brunswick, New Jersey.
Recalled by: Adonis Health Products, Baldwin City, Kansas, by
telling mail order customers product was discontinued;
by stamping discontinued in catalogs; and by letter.
Firm-initiated recall complete.
Distribution: Nationwide and international.
Quantity: Approximately 412 bottles were distributed.
Reason: Product marketed without an Approved New Drug Application.
----
Product: Whole Blood. Recall #B-099-2.
Code: Unit #131989.
Manufacturer: Blood Bank of Delaware, Inc., Newark, Delaware.
Recalled by: Manufacturer, by telephone March 20, 1991. Firm-initiated
recall complete.
Distribution: Delaware.
Quantity: 1 unit.
Reason: A unit of Whole Blood, collected from an ineligible
donor due to a history of recurring night sweats,
was distributed.
----
Product: Red Blood Cells. Recall #B-108-2.
Code: Unit #4659671.
Manufacturer: Department of the Navy, Naval Hospital, Groton, Connecticut.
Recalled by: Manufacturer, by memorandum February 25, 1991. Firm-
initiated recall complete.
Distribution: New Jersey.
-5-
Quantity: 1 unit.
Reason: Blood product, which tested reactive for the antibody
to the human immunodeficiency virus type 1 (anti-HIV-1),
was distributed.
----
Product: (a) Source Leukocytes; (b) Source Plasma.
Recall #B-111/112-2.
Code: Unit numbers: (a) 203279, 207955, 224669;
(b) 198073, 198471, 203089, 204142, 205207, 205499,
206379, 206794, 207443, 207955, 208701, 209360, 211123,
224669, 229726, 230941, 231855, 232220, 232925, 234513,
235346, 236858.
Manufacturer: North American Biologicals, Inc., (NABI), Grand River
Donor Center, Detroit, Michigan.
Recalled by: NABI, Miami, Florida, by letters dated August 29, 1991.
Firm-initiated recall ongoing.
Distribution: North Carolina, New Jersey, Austria, Switzerland.
Quantity: (a) 3 units; (b) 22 units.
Reason: Blood products from donor who tested initially
reactive to the hepatitis B surface antigen (HBsAg),
were distributed.
----
Product: Platelets, Pheresis. Recall #B-113-2.
Code: Unit #0237253.
Manufacturer: Bergen Community Regional Blood Center, Paramus,
New Jersey.
Recalled by: Consignee discovered error and returned unit to
firm August 7, 1991. Recall complete.
Distribution: New Jersey.
Quantity: 1 unit.
Reason: Blood products, labeled with incorrect expiration
dates, were distributed.
----
Product: Red Blood Cells. Recall #B-115-2.
Code: Unit numbers 25FR03816, 25LM00549, 25FR03833, 25FR013818,
25LM00551, 25FR03828, 25LM00566, 25E66079, 25FR03815,
25LM00455, 25LM00555, 25GW06723, 25GW06778, 25GW06730,
25GW06729, 25GP05037.
Manufacturer: American Red Cross Blood Services, Syracuse, New York.
Recalled by: Manufacturer, by telephone January 17, 1991, followed
by letter May 30, 1991. Firm-initiated recall complete.
Distribution: New York.
Quantity: 16 units.
Reason: Blood components, which were previously shipped
under unacceptable temperatures for an indeterminate
amount of time, were distributed.
----
-6-
CORRECTION: Olympus PK TP System Test Kit for screening of Treponema
pallidum antibodies, Recall #B-070-2 which appeared in the
December 26, 1991 Enforcement should read:
Quantity: 128 kits were distributed.
----
Class III -
Product: Film-Coated Aspirin, 5 grain, an OTC product in bottles
of 100, 250, 270, 300, and 500 tablets, under Granutec House
label of "CPL", Eckerd Drug, Super D, Smitty's, Shopko,
Perry Drug, Medi-Save, Mason Drugs, K & B, Kerr Drugs,
Harco, Harbest, FDC and Fays. Recall #D-195-2.
Code: Lot numbers: 007372, 010034, 009128, 009170, 007378,
011143, 009171, 007243, 007257, 012008, 002018, 006164,
007418, 008023, 010085, 011140, 006250, 009160, 010042,
010290, 009133, 010154, 010187, 010004, 009130, 003184,
010166, 010137, 008027, 008063, 010258, 010059, 101019,
009109, 009070, 010162, 010100, 011074, 011075, 010193,
008382, 009175.
Manufacturer: Granutec, Inc., Wilson, North Carolina.
Recalled by: Manufacturer, by letter November 27, 1991. Firm-initiated
recall ongoing.
Distribution: Florida, Texas, Georgia, North Carolina, Tennessee,
Ohio, Arizona, Wisconsin, Missouri, Utah, Illinois,
Michigan, Louisiana, New Jersey, California, Alabama,
Virginia, New York, Kentucky.
Quantity: 146,388 100-count units, 5,184 250-count units,
13,068 270-count units, 32,592 300-count units,
65,912 500-count units were distributed.
Reason: Product does not meet dissolution specifications.
----
Product: Oxygen, USP, Medical Gas packed into size D and E
cylinders. Recall #D-196-2.
Code: Lot numbers 06-14 91, 06-25 91, 06-28 91.
Manufacturer: Liberty Medical, Inc., Westlake, Ohio (formerly known
as Liberty Respiratory, Inc.)
Recalled by: Manufacturer, by letter December 18, 1991, followed by
telephone and visit. Firm-initiated recall ongoing.
Distribution: Ohio.
Quantity: 95 cylinders were distributed; firm estimates less than
12 remain in distribution.
Reason: Purity level below U.S.P specifications.
----
Product: Promethazine Syrup, plain, promethazine hydrochloride
6.25 mg/5 ml, a Rx clear green oral liquid antihistaminic
used in the treatment of allergies, in 5 ml unit dose
cups. Recall #D-198-2.
-7-
Code: Lot numbers: 102605 EXP 2/92, 105607 EXP 4/92, 106605
EXP 6/92, 107602 EXP 7/92, 109610 EXP 9/92, 110613 EXP 10/92.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Xactdose, Inc., South Beloit, Illinois (repacker/
responsible firm), by letter January 6, 1992.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,330 cases (10 cups per tray, 10 trays per carton)
were distributed; firm estimates 130 cases remain on
the market.
Reason: Label incorrectly declares product as an expectorant
and antitussive.
----
Product: Red Blood Cells. Recall #B-109-2.
Code: Unit #23F19620.
Manufacturer: American Red Cross Blood Services, Asheville, North
Carolina.
Recalled by: Manufacturer, by telephone June 14, 1991. Firm-
initiated recall complete.
Distribution: North Carolina.
Quantity: 1 unit.
Reason: Blood product, which was labeled with an incorrect
expiration date, was released.
----
Product: Platelets. Recall #B-110-2.
Code: Unit #2518528.
Manufacturer: Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
Recalled by: Manufacturer, by telephone April 29, 1991. Firm-
initiated recall complete.
Distribution: Indiana.
Quantity: 1 unit.
Reason: Blood product, which tested non-reactive for the
antibody to the human immunodeficiency virus type 1
virus (anti-HIV-1) but was collected from a donor who
previously tested anti-HIV-1 reactive, was released.
----
Product: Red Blood Cells. Recall #B-114-2.
Code: Unit #0231298.
Manufacturer: Bergen Community Regional Blood Center, Paramus,
New Jersey.
Recalled by: Consignee discovered error and returned unit to
firm July 18, 1991. Recall complete.
Distribution: New Jersey.
Quantity: 1 unit.
Reason: Blood product labeled with incorrect expiration
dates was distributed.
----
-8-
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Olympus Endoscope Washer (a) Model EW-10; (b) Model EW-20.
Recall #Z-039/040-2.
Code: All serial numbers.
Manufacturer: Olympus Corporation, Tokyo, Japan.
Recalled by: Olympus Corporation, Lake Success, New York, by
letter October 16, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 290 units; (b) 545 units were distributed.
Reason: Inadequate design of the device may allow colonization
of water-borne organisms such as Pseudomonas in the
internal tanks and tubing.
----
Product: Laerdal Silicone Resuscitators, adult, child, and
infant models. Recall #Z-205-2.
Code: Adult size model numbers: 87 00 00, 87 00 16, 87 00 01,
87 00 03, 87 00 05;
Child size model numbers: 86 00 00, 86 00 16, 86 00 01,
86 00 03, 86 00 05;
Infant size model numbers: 85 00 00, 85 00 16, 85 00 01,
85 00 03, 85 00 05.
Manufacturer: Laerdal Medical, Stavanger, Norway.
Recalled by: Laerdal Medical Corporation, Armonk, New York, by
letter on or about the first week of June 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Several thousand resuscitators remain in commerce.
Reason: Labeling did not contain adequate instructions for use.
----
Product: The Pulsator Contact Lens Cleaning Accessory, used with
contact lens solutions to loosen and remove normal tear
residues and debris for hard, soft and rigid gas
permeable contact lenses. Recall #Z-206-2.
Code: Not coded. All outstanding stock.
Manufacturer: Chinese Enterprise, Inc., Taipei, Taiwan.
Recalled by: Eaton Medicals Corporation, Memphis, Tennessee, by
telephone November 7, 1991, followed by letter
November 11, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 312 units were distributed; firm estimates 244 units
remain on the market.
-9-
Reason: The labeling does not contain adequate directions for
use and other label deficiencies. Further, the device
has been marketed without an approved 510(k) premarket
notification.
----
Product: Model V2465P Image Intensifier for medical diagnostic
x-ray fluoroscopy. Recall #Z-233-2.
Code: Undetermined.
Manufacturer: Hamamatsu Corporation, Bridgewater, New Jersey.
Recalled by: Manufacturer. FDA approved the firm's corrective action plan
November 29, 1991. Firm-initiated field correction ongoing.
Distribution: California.
Quantity: 1 unit.
Reason: Noncompliance with the performance standard for x-ray
products in that it was sold for medical use without a
certification label.
----
Product: Hewlett-Packard M1900A Adapter Cables used with
Hewlett-Packard Sa02 Pulse Oximeter Monitoring
Equipment Module 78352C with Options A05 and 16, and
Model 78354C with Options A14, A17, A18 and A51.
Recall #Z-234-2.
Code: Problem arises with model numbers 78834C used with Options
A19, C20, C30 AND C36;
Model 78834CU used with Options E05
Model 78352A used with Options A15, A16
Model 78352C used with Options AO5, A16, A66, 297
Model 78354A used with Options A14, A17, A18, 298, A19, 289
Model 78354AU used with Options 772, E15
Model 78354C used with Options A14, A17, A18, A19, A51,
298, 285
Model 78354CU used with Options A55 when used with damaged
Nellcor SA02 sensors or HPM1900A Nellcor Adapter
Cables are used.
Manufacturer: Hewlett-Packard, Boblingen, West Germany (importer).
Nellcor Inc., Hayward, California (cable component).
Recalled by: Hewlett-Packard, Waltham, Massachusetts, by letter
September 12, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 14,319 monitors were distributed.
Reason: Thermal burns may occur on the patient at the sensor site
if the monitoring equipment is used with damaged Nellcor
Sa02 Sensors or HPM1900A Adapter Cables for the Nellcor
Sensor.
----
Product: (a) 5 French Urinary Catheter;
(b) FST 200 Pressure Monitoring System
-10-
Code: Polyurethane urinary catheter equipped with a sensor
(transducer) connected to a fiberoptic cable to be used
with the FST 200 Pressure Monitor to monitor the pressure
exerted against the bladder wall for diagnostic purposes.
Recall #Z-237/238-2.
Code: Catalog number is UD5. No expiration date.
LOT # SERIAL #
M200090 0189, 0105, 0172, 0121, 0101, 0071, 0080,
0007, 0225, 0186, 0134, 0212, 0046, 0081,
0127, 0074, 0104, 0107, 0184
M200070 0128, 0110, 0088, 0089, 0093, 0092, 0039,
0114
M200130 0628, 0500, 0653, 0409, 0742, 0610, 0575,
0636, 0802
M200060 0059, 0021, 0016, 0035, 0012, 0031
Monitor Codes - The monitors are assigned a serial number.
The following is a list of the serial numbers under recall:
064AS2, 065AS2, 053CS2, 059AMS2, 078AS2, 068AS2, 085AS2,
086AS2.
Manufacturer: FiberOptic Sensor Technologies, Inc., Ann Arbor, Michigan.
Recalled by: Manufacturer, by telephone October 31, 1991. Firm-
initiated recall complete.
Distribution: Michigan, Massachusetts, Minnesota, Pennsylvania.
Quantity: 42 catheters and 8 monitors were distributed.
Reason: The device has been marketed without an approved 510(k)
premarket notification.
----
Product: Collimators used in stationary C-arm fluoroscopic
systems: (a) Model TF-UA-2; (b) Model TF-UA-2L.
Recall #Z-251/252-2.
Code: Undetermined.
Manufacturer: Toshiba America Medical Systems, Inc., Tustin, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan November 27, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: (a) 61 units; (b) 149 units were distributed.
Reason: Devices failed to meet the source-skin distance (SSD)
requirement for stationary fluoroscopic systems as stated
in 21 CFR 1020.32(f).
----
Product: Model KXO-50N and KXO-80N Control/Generator used in
systems incorporating an EPS-20 Electronic Photospot Camera.
Recall #Z-253/254-2.
Code: Undetermined.
Manufacturer: Toshiba America Medical Systems, Inc., Tustin, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action plan
November 29, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide.
-11-
Quantity: 2 units were distributed.
Reason: Devices failed to comply with 21 CFR 1020.32(c), Actuation
of tube, and 21 CFR 1020.32(e), indication of potential and
current requirements for fluoroscopic systems due to
problems in control software.
----
Product: Model BLR-15AA Collimator used in general radiographic
and tomographic systems. Recall #Z-255-2.
Code: Undetermined.
Manufacturer: Toshiba America Medical Systems, Inc., Tustin, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action plan
November 29, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 92 units were distributed.
Reason: Devices failed to comply with 21 CFR 1020.30(h)(4)(ii)
requirements for diagnostic x-ray products in that the
user has not been properly informed about the actual
aluminum equivalence of the filters which can be selected.
----
Product: Insall/Burstein II 5 mm Tibial Augmentation Blocks:
(a) Augmentation Block Unsterile, product numbers:
31-8554-054-05, 31-8554-059-05, 31-8554-064-05,
31-8554-069-05, 31-8554-074-05;
(b) Augmentation Block, Sterile, product numbers:
32-8554-054-05, 32-8554-059-05, 32-8554-064-05,
32-8554-069-05, 32-8554-074-05. Recall #Z-257/258-2.
Code: Product Numbers Lot numbers:
(a) 31-8554-054-05 33115400, 33110300
31-8554-059-05 33115600, 33110500
31-8554-064-05 33115800, 33110700
31-8554-069-05 33116000, 33110900
31-8554-074-05 33116200, 33111100
(b) 32-8554-054-05 33249800, 33178400, 33066200
32-8554-059-05 33261500, 33250000, 33231800, 33231900,
33193200, 33178600, 33066400
32-8554-064-05 33331200, 33261900, 33250200,
33232200, 33232300, 33193400,
33178800, 33066600, 06138800, 06138900
32-8554-069-05 33262300, 33250400, 33232600, 33232700,
33193600, 33179000, 33066800, 06139900
32-8554-074-05 33180100, 33067000
Manufacturer: Zimmer, Inc., Warsaw, Indiana.
Recalled by: Manufacturer, by telephone October 17-18, 1991, followed
by letter October 21, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Japan, France.
Quantity: 252 pieces subject to recall.
Reason: The augmentation block may not tighten up with the tibial
plate (tray).
----
-12-
Product: Hewlett-Packard Central Station Monitor and Arrhythmia
Monitoring Option with Option A05-Six patient multiwave
configuration with 2-channel delayed realtime recording.
Recall #Z-260-2.
Code: HP 78560A/Option A05 - All units.
Manufacturer: Hewlett-Packard, Waltham, Massachusetts.
Recalled by: Manufacturer, by letter October 15, 1991. Firm-initiated
field correction ongoing.
Distribution: Nationwide, Canada, Germany, Australia, Hong Kong,
Singapore, Taiwan, Australia.
Quantity: 430 monitors were distributed.
Reason: Software problem - Misinterpretation of a patient's
condition could occur due to corruption of the second
channel of a 2-channel delayed recording when the patient
parameters at the bedside monitor are turned off during a
delayed recording.
----
Product: Model CO2 Laser Machine Tool Workstation (F series).
Recall #Z-261-2.
Code: Undetermined.
Manufacturer: MC Machinery Systems, Inc., Wood Dale, Illinois.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan January 10, 1992. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 12 units.
Reason: Noncompliance with the performance standard for laser
products in that it lacked adequate protective housing
shield; adequate user instructions for calculating the
Normal Hazard Zone (NHZ) surrounding the Class IV laser
product.
----
Class III -
Product: X-Ray Bone Densitometer, a device that uses the
technique known as Dual Energy X-Ray Absorptiometry (DEXA)
to estimate skeletal bone mineral in vivo. Recall #Z-136-2.
Code: Serial numbers: 633 through 734 (except 634, 640, 657, 658,
685, and 732) plus 389, 390, 391, 398, 399, 405, 406, 604,
605, 2005, 2006, 2007.
Manufacturer: Norland Corporation, Ft. Atkinson, Wisconsin.
Recalled by: Manufacturer, by letter September 6, 1991. Firm-initiated
field correction ongoing.
Distribution: Virginia, California and international.
Quantity: 108 units were distributed.
Reason: A crimping problem at the cable terminals may cause
loss of electrical connection and result in the unit
failing daily calibration.
----
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Product: Oxoid Bile Aesculin Discs DD18, used for the
identification of Enterococcus species Enterobacteriacene,
Listeria monocytogenes and anerobic organisms and
presence of constitutive enzymes. Recall #Z-219-2.
Code: 36751 EXP 2/92.
Manufacturer: Unipath Ltd., Basingstoke, England.
Recalled by: Unipath Company, Oxoid Division, Ogdenburg, New York
(importer), by telephone December 5 and 6, 1991, followed by
letter on or about December 12, 1991. Firm-initiated
recall ongoing.
Distribution: Pennsylvania, Ohio, Florida, Illinois.
Quantity: 11 vials (each containing 50 discs) were distributed.
Reason: The product no longer gives a clear color reaction.
The use of these discs could lead to failure to
identify the presence of an aesculin-hydrolysing organism.
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Product: Unipolar Provisional Liner, Product #5003-44-01, a dummy
implant/sizing instrument used for sizing purposes to
determine the correct size of an acetabular cup shell
and acetabular cup poly liner to use in a hip implant
procedure. Recall #Z-256-2.
Code: Lot #74515300.
Manufacturer: Zimmer, Inc., Warsaw, Indiana.
Recalled by: Manufacturer, by letter November 8, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 52 pieces were distributed.
Reason: The provisional liner was stamped 38-43 mm OD, but
the actual size is 44-49 mm OD.
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VETERINARY PRODUCTS
NONE
----
Injunction Action Filed:
Against: Gulf Harvest Seafood, Inc., and Roger C. Van Dyke and
Ronald M. Engle, Port Arthur, Texas.
Product: Crabmeat (90-604-788/792).
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Charge: Adulterated - Product contained a poisonous or deleterious
substance, Listeria monocytogenes, and was packed,
prepared, or held under insanitary conditions whereby it
may have been contaminated with filth.
Filed: November 15, 1991 - U.S. District Court for the
Eastern District of Texas, Beaumont Division;
Civil #1:91-CV0905, INJ #1272.
Consent Decree: Signed by the firm on December 13, 1991.
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