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
06/29/1994
Recalls and Field Corrections: Foods -- Class I -- 06/29/1994
June 29, 1994 94-26
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Frookie All Natural Chocolate Chip Cookies, 6.5 ounces.
Recall #F-704-4.
CODE Lot numbers: 31184P, 21194P, 31194P, 21254P, 31254P,
11264P, 21314P, 31314P, 21374P, 11374P, 11444P, 11194.
MANUFACTURER Imperial Baking, St. Louis, Missouri.
RECALLED BY R.W. Frookies, Inc., Sag Harbor, New York, by letters of
April 5, 1994, and May 23, 1994, and by press release April
7, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates that fewer than 3,500 cases (12 boxes per
case) remain on market.
REASON Product contains pecans which are not declared on the label.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Tops brand Non-Dairy Creamer, frozen, 32 ounces.
Recall #F-706-4.
CODE 4055 (C, D, G, or H).
MANUFACTURER Rich Products Corporation, Buffalo, New York.
RECALLED BY Manufacturer, by telephone May 19, 1994, followed by letter
May 19, 1994. Firm-initiated recall complete.
DISTRIBUTION New York, Pennsylvania.
QUANTITY 671 cases (12 units per case) were distributed between
February and May 1994.
REASON Product contains undeclared sodium caseinate.
_______________
PRODUCT Mint Chip Ice Cream, pure chocolate chips in mint flavored
ice cream packaged in half gallon round paperboard tubs.
Recall #F-705-4.
CODE Lot #07394.
MANUFACTURER Gillette Dairy, Norfolk, Nebraska.
RECALLED BY Manufacturer, by telephone May 11, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nebraska, Iowa, Missouri.
QUANTITY Approximately 1,518 units were distributed.
REASON Product contains undeclared FD&C Yellow #5.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Pitressin (Vasopressin Injection, USP) Steri-Vial 10 Pressor
Units, in 0.5 ml, Synthetic 25/0.5 ml glass vials.
Recall #D-305-4.
CODE Lot numbers: 022N2PN EXP 3/94, 03792PH EXP 1/94.
MANUFACTURER Warner-Lambert Company, Parke-Davis Division, Rochester,
Michigan.
RECALLED BY Parke-Davis Division of Warner-Lambert Company, Morris
Plains, New Jersey, by letter January 20, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Canada.
QUANTITY 791 cartons of 25 vials of lot 022N2PN, 1,024 cartons of 25
vials of lot 03792PH were distributed.
REASON Portion of carton label bears incorrect route of
administration.
_______________
PRODUCT Procan SR Tablets (Procaine Hydrochloride Extended Release
Tablets), indicated for the treatment of documented
ventricular arrhythmias: (a) 250 mg; (b) 500 mg; (c) 750
mg. Recall #D-312/314-4.
CODE Lot numbers: (a) 01872VA EXP 6/94, 01872VB EXP 6/94; (b)
08442VB EXP 4/94, 04052VB EXP 4/94, 04142VB EXP 4/94,
01972VA EXP 6/94, 10382VA EXP 7/94, 08092VA EXP 8/94,
08192VA EXP 8/94, (c) 05852VA EXP 5/94, 08872VA EXP 7/94,
07392VA EXP 8/94, 03523VA EXP 1/95, 03623VA EXP 1/95,
03723VA EXP 1/95, 03823VA 1/95, 04353VA EXP 4/95, 04453VA
EXP 4/95, 03873VA EXP 6/94, 04052V EXP 4/94, 05852V EXP
5/94, 07392V EXP 8/94, 04453VA 4/95. The following lots
were shipped to Parke-Davis in Brockville, Canada for
Canadian distribution: 08442V, 04052V, 10382V (500 mg);
05852V, 03523V, 03623V (750 mg).
-2- MANUFACTURER Warner Lambert, Vega Baja, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert, Morris Plain, New
Jersey, by letter April 29, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Firm estimates little product remains on the market.
REASON Abbreviated New Drug Application deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Parke-Davis Consumer Health Products Group brand Benadryl
Tablets 25 mg, OTC antihistamine, in bottles of 100.
Recall #D-306-4.
CODE Lot #09033V EXP 8/94.
MANUFACTURER Warner-Lambert Company, Vega Baja, Puerto Rico.
RECALLED BY Warner-Wellcome, Consumer Health Product, Morris Plains, New
Jersey, by letter mailed week of April 25, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23,808 bottles were distributed.
REASON Subpotency.
_______________
PRODUCT Methenamine Mandelate 1.0 Tablets, oral solid dosage form
packaged in 100 and 1,000 tablet bottles, Rx antiseptic for
urinary tract infections. Recall #D-307-4.
CODE 3053A EXP 6/95, 3167A EXP 12/95.
MANUFACTURER Amide Pharmaceutical, Inc., Little Falls, New Jersey.
RECALLED BY Manufacturer, by letter April 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION New York, Florida, California, Indiana.
QUANTITY 48 bottles of 1000 and 288 bottles of 100 tablets were
distributed.
REASON Non-validated manufacturing process.
_______________
PRODUCT Duragesic Fentanyl Transdermal System controlled substance
Rx drugs: (a) 25 mcg/hr; (b) 50mcg/hr. Recall #D-308/309-4.
CODE Lot numbers: (a) 131305, 131306; (b) 132306, 132307.
MANUFACTURER Alza Corporation, Vacaville, California.
RECALLED BY Janssen Pharmaceutica, Titusville, New Jersey, by letter on
or about February 25, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 66,653 cartons of lot 131305, 19,061 cartons of lot 131306,
35,230 cartons of lot 132306, and 15,159 cartons of lot
132307 were distributed.
REASON Release rate does not meet product specifications.
-3- _______________
PRODUCT Flurazepam Hydrochloride Capsules, USP, 30 mg, Rx schedule
IV narcotic oral hypnotic for the treatment of insomnia.
Recall #D-310-4.
CODE Lot 4A154 EXP 7/95.
MANUFACTURER Mylan Pharmaceuticals, Morgantown, West Virginia.
RECALLED BY UDL Laboratories, Rockford, Illinois (repacker/responsible
firm), by letter June 15, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,190 unit cartons were distributed.
REASON Some unit cartons may be mislabeled as Temazepam Capsules 15
mg. The unit dose packs are correct.
_______________
PRODUCT Tagamet (brand of Cimetidine) 800 mg, in bottles of 30,
indicated for short-term treatment of active duodenal ulcer.
Recall #D-311-4.
CODE Lot #8034T27 EXP 1/3/196.
MANUFACTURER Smith Kline Beecham Pharmaceuticals, Cidra, Puerto Rico.
RECALLED BY Manufacturer, by letter May 23, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 61,992 units were distributed.
REASON A tablet of Relafen 750 mg was found in a bottle of Tagamet
800 mg.
_______________
PRODUCT Miochol (Acetylcholine Chloride) 1:100 Intraocular, 10
mg/2ml, in 2 ml vials, used to obtain complete miosis of the
iris in seconds after delivery of the lens in cataract
surgery. Recall #D-315-4.
CODE Lot numbers: R4807D EXP 11/96 (Iocare Steri-Tags), R4807E
EXP 11/96, R4808E EXP 12/96 (System Paks).
MANUFACTURER Iolab, Inc., San German, Puerto Rico.
RECALLED BY Iolab, Claremont, California, by letter May 20, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,225 units were distributed; firm estimates none remains
on market.
REASON Product does not meet pH specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-308/310-4.
CODE Unit #22LF63110.
MANUFACTURER The American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by letter October 19, 1993. Firm-initiated
recall ongoing.
-4- DISTRIBUTION Pennsylvania, California.
QUANTITY 1 unit of each component.
REASON Blood products collected from a donor taking Proscar were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-339-4.
CODE Unit #03LT10561.
MANUFACTURER American Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter August 8, 1993. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit.
REASON Red Blood Cells, collected from a donor who traveled to an
endemic area for malaria and had taken prophylactic anti-
malarial medication prior to donation, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Fresh Frozen Plasma; (e) Platelet, Expired; (f)
Recovered Plasma; (g) Recovered Human Serum (Pool).
Recall #B-341/347-4.
CODE Unit numbers: (a) 31G44005, 31GE01404, 31GE02485,
31GE04447, 31T12697, 31T16663, 31T18895, 31T20598, 31T22927,
31V32870, 31W73945; (b) 31G44005, 31GE04447, 31T12697,
31T16663, 31T18895, 31T22927, 31V32870, 31W73945; (c)
31G44005, 31T22927, 31GE01404; (d) 31T12697, 31T16663,
31T18895, 31T20598, 31W73945; (e) 31T20598; (f) 31GE01404,
31GE02485, 31GE04447, 31T22927, 31V35314; (g) 31GE01404
(9RB1512-1-S), 31GE04447 (90RB03017), 31T16663 (92RB3602S),
31T18895 (93RB3060S), 31T20598 (93RB3115S), 31T22927
(93RB3182S), 31W73945 (92RB3523S).
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by telephone from September 15, 1993 through
December 7, 1993, and by letters dated from June 1, 1993,
through December 12, 1993. Firm-initiated recall ongoing.
DISTRIBUTION New York, Pennsylvania, California, South Carolina,
Oklahoma, Alabama, Ohio, Georgia, Massachusetts,
Switzerland.
QUANTITY (a) 11 units; (b) 8 units; (c) 3 units; (d) 5 units; (e) 1
unit; (f) 5 units; (g) 7 units.
REASON Blood products which were collected from a donor with a
history of cancer; or tested negative but were collected
from donors who previously tested repeatedly reactive for
the antibody to the human immunodeficiency virus type 1
(anti-HIV-1), were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets, Expired; (c) Recovered
Plasma. Recall #B-350/352-4.
CODE Unit numbers 1098037, 5070552.
MANUFACTURER Northwest Florida Blood Center, Inc., Pensacola, Florida.
-5- RECALLED BY Manufacturer, (a) by letter May 25, 1993 and by telephone
January 4, 1993; (b&c) telephone December 30, 1992, and by
letter May 25, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY 2 units of each component.
REASON Blood products, which tested negative for all viral markers,
but were collected from donors who participated in high risk
behavior or experienced an occupational needle stick
exposure less than 12 months prior to donation, were
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Influenza Virus Vaccine Trivalent types A and B, Subvirion
Formula 1993-1994, Connaught Flu Vaccine, in prefilled 0.05
ml unit dose syringe. Recall #B-338-4.
CODE Lot #3M41109.
MANUFACTURER Connaught Laboratories, Inc., Swiftwater, Pennsylvania.
RECALLED BY Manufacturer, by letter March 29, 1994. Firm-initiated
recall complete.
DISTRIBUTION Argentina.
QUANTITY 30,000 units were distributed.
REASON In translating labeling from English to Spanish, a portion
of the indication section was omitted.
_______________
PRODUCT (a) Granulocytes Apheresis; (b) Recovered Plasma.
Recall #B-348/349-4.
CODE Unit numbers: (a) 31GJ04300; (b) 31G44005, 31V32870.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by telephone September 15, 1993, November 12,
1993, and December 7, 1993, and by letters dated June 1,
1993, September 17 and 24, 1993, November 22, 1993, and
December 10, 1993. Firm-initiated recall ongoing.
DISTRIBUTION New York, California, Massachusetts, Switzerland.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products which were collected from a donor with a
history of cancer or stored at an unacceptable temperature
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Prowess 2000 Radiation Treatment Planning Software Package,
Version 2.08. Recall #Z-740-4.
CODE None.
MANUFACTURER Small Systems Group, Inc., Chico, California.
RECALLED BY Manufacturer, by letter January 13, 1993. Firm-initiated
field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 96 units.
-6- REASON Calculations in the brachytherapy module produced dose
errors of 48 percent.
_______________
PRODUCT AC Power Adaptor or Transformer labeled "Component Power
Supply Class 2, Part #394-4010-001, intended for use with
medical and dental equipment. Recall #Z-793-4.
CODE All lots except revision E.
MANUFACTURER Ault, Inc., Minneapolis, Minnesota.
RECALLED BY CNS, Inc., Chanhassen Minnesota, by letter November 8, 1993.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and canada.
QUANTITY 333 units were distributed.
REASON Some adaptors exceeded leakage current specifications, due
to loose fuses or fuses in close proximity to the
transformer lamination stack.
_______________
PRODUCT Sterile ophthalmic solutions for use with contact lenses:
(a) Sherman Pharmaceutical Stay-Wet 3 preserved wetting and
"in eye" lubricating solution and rewetting drop for use
with fluoro/silicone crylate and silicone acrylate rigid gas
permeable (RPG) contact lenses, .33 ounces (10 ml) sample
size;
(b) Sherman Pharmaceutical Stay-Wet 3 preserved wetting and
"in eye" lubricating solution and rewetting drop for use
with fluoro/silicone acrylate and silicone acrylate RPG
contact lenses, 1 fluid ounce (30 ml) size;
(c) Wukvision Stay-Wet 3 preserved wetting and "in eye"
lubricating solution and rewetting drop for use with
fluoro/silicone acrylate and silicone acrylate RPG contact
lenses, 10 ml size;
(d) Sherman Pharmaceutical de Stat 3 cleaning, disinfecting
and storage solution for use with fluoro/silicone acrylate
and silicone acrylate RPG contact lenses, 1 fluid ounce (30
ml) sample size;
(e) Sherman Pharmaceutical de Stat 3 cleaning, disinfecting
and storage solution for use with fluoro/silicone acrylate
and silicone acrylate RPG contact lenses, 4 fluid ounces
(118 ml) size;
(f) Wukvision de Stat 3 cleaning, disinfecting and storage
solution for use with fluoro/silicone acrylate and silicone
acrylate RPG contact lenses, 118 ml size;
(g) Wukvision de Stat 3 cleaning, disinfecting and storage
solution for use with fluoro/silicone acrylate and silicone
acrylate RPG contact lenses, 30 ml size;
(h) Sherman Pharmaceutical Sof/Pro-Clean cleaning solution
for use with all soft (hydrophilic) contact lenses in heat
(thermal) and chemical (not heat) lens care systems, 1 fluid
ounce (30 ml) size;
-7- (i) Choongwae Pharma Corporation Sof/Prp-Clean cleaning
solution for use with all soft (hydrophilic) contact lenses
in heat (thermal) and chemical (not heat) lens care systems,
30 ml size. Recall #Z-931/939-4.
CODE Lot numbers: (a) 1793; (b) 363; (c) 1793; (d) 3452, 3642;
(e) 2332, 1603; (f) 1603; (g) 3642; (h) 1392, 1842, 1852;
(i) 1842, 1852.
MANUFACTURER Sherman Pharmaceuticals, Inc., Mandeville, Louisiana.
RECALLED BY Manufacturer, by letter May 9, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 26,371 units of Stay-Wet 3; approximately
45,906 units of de-Stat; and approximately 63,786 units
Sof/Pro-Clean from all lot numbers involved were
distributed.
REASON Product sterility may have been compromised due to potential
inadequate sterilization.
_______________
PRODUCT IVAC Core-Check Tympanic Thermometer System, Model 2090A, a
hand-held thermometer which, when positioned in the external
auditory canal, measures the infrared energy emitted from
the tympanic membrane. Recall #Z-963-4.
CODE All lot numbers.
MANUFACTURER IVAC Corporation, San Diego, California.
RECALLED BY Manufacturer, by issuing a service bulletin in February
1992, and by letter February 14, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 11,518 units were distributed from August 1991 to October
1992; firm estimated 10,255 units remained on market at time
of recall.
REASON Inadequate shielding allowing high levels of electromagnetic
or radio interference to possibly cause device malfunction.
_______________
PRODUCT IPI Respiratory Therapy Fluid Transfer Sets with Luer Tip
and Spring Loaded Clamp, Catalog #1122, a sterile
prescription device used to transfer respiratory therapy
solutions to the desired respiratory device.
Recall #Z-965-4.
CODE Lot #D040.
MANUFACTURER IPI Medical Products, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone March 10, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Illinois, Ohio, North Carolina, Massachusetts, Arizona,
Georgia.
QUANTITY 37 cases were distributed; firm estimated that 7 cases
remained on market at time of recall.
REASON The clamp on the sets were glued in the open position.
-8- _______________
PRODUCT MDE Defibrillator Model 19E and MDE Defibrillator with Pacer
Model 20E, options used with the Escort 300 Series full
parameter transport monitor. Both options are low energy DC
defibrillators which are able to deliver an electrical shock
with a range of 2 to 360 joules of energy.
Recall #Z-968/969-4.
CODE Serial numbers 1198 through 1307.
MANUFACTURER Medical Data Electronics, Inc., Arleta, California.
RECALLED BY Manufacturer, by letter December 2, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Hong Kong, Korea, the Philippines.
QUANTITY 110 units were distributed.
REASON The energy selector switch can be set between the detented
increments of the switch causing higher than selected energy
to be delivered.
_______________
PRODUCT Hot Choice Microwave Oven, Model 122000, used in heating
frozen prepared pizza or chicken using convection/microwave
energy. Recall #Z-978-4.
CODE Serial numbers: Undetermined.
MANUFACTURER Kaiser Electroprecision, Irvine, California.
RECALLED BY Manufacturer. FDA Approved the firm's corrective action
plan June 16, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION California.
QUANTITY 30 units.
REASON Product failed to meet the certification labeling
requirements.
_______________
PRODUCT First Medic Defibrillators (a) Model 90510 (FM 510); (b)
Model 90526 (FM 610). Recall #Z-979/980-4.
CODE Serial numbers: (a) 510B00312 - 510B00458, 510C00314 -
510C01074; (b) 526B01865 - 526B01915, 526C01681 - 526C02426.
MANUFACTURER SpaceLabs Medical, Inc., Redmond, Washington.
RECALLED BY Manufacturer, by letter April 26, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 610 units; (b) 483 units were distributed.
REASON The material (tin) used for the plating of the isolation
module shield is susceptible to metal fiber growth that, if
oriented in a certain fashion, can make contact with the
connector pins and result in a small electrical short
circuit condition for the device.
_______________
PRODUCT Mevatron Linear Accelerator and Mevasim Therapy Simulator -
Overhead Suspension Hand Control. Recall #Z-981-4.
CODE Overhead Suspension Assembly-A12, Part #94 10 309. Used in
conjunction with all conventional and digital Mevatron
Linear Accelerators and Mevasim Therapy Simulators.
-9- MANUFACTURER Siemens Medical Systems, Inc., Concord, California.
RECALLED BY Manufacturer, by letter October 29, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,141 units.
REASON The devices were distributed with a defective weld that can
fail and cause the overhead support plate (which weighs 45
pounds) to fall.
_______________
PRODUCT Mevatron Linear Accelerator Wedge Filter Assembly, used with
the Mevatron Therapeutic X-ray Machine. Recall #Z-982-4.
CODE All codes.
MANUFACTURER Siemens Medical Systems, Inc., Concord, California.
RECALLED BY Manufacturer, by letter October 29, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 4,000 wedges were distributed 1976-1993.
REASON The devices were distributed with defective connection
screws between the wedge filters and the aluminum trays
which could allow the wedge to fall from the mounting tray.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Calibration Gas Mixture, in UD size cylinders, used as a
calibration or check standard for anesthesia monitoring.
Recall #Z-942-4.
CODE Lot #131403 EXP 5/95.
MANUFACTURER Scott Medical Products, Plumsteadville, Pennsylvania.
RECALLED BY Manufacturer, by telephone April 22 and 27, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Texas, Indiana, Iowa, California.
QUANTITY 5 cylinders were distributed.
REASON The product which is 30% oxygen is incorrectly labeled as
containing 21% oxygen.
_______________
PRODUCT Cynomologus Monkey Kidney tubes, Catalog #70-177-D, used for
the isolation of virus in clinical specimens.
Recall #Z-950-4.
CODE Lot #2C0087.
MANUFACTURER Whittaker Bioproducts, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by telephone January 20, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 125 units were distributed.
REASON Product was contaminated with gram positive Bacillus
species.
-10- _______________
PRODUCT Rhesus Monkey Kidney Tubes with SV5 and SV40 Antiserum cell
cultures which is used for isolation of virus in clinical
specimens. Recall #Z-951-4.
CODE Catalog #70-103D, Lot #2C0449.
MANUFACTURER Whittaker Bioproducts, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by telephone March 4, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,474 units were distributed; firm estimates none remains on
the market.
REASON Product was contaminated with Micrococcus, Bacillus, and
Coryneform bacteria.
_______________
PRODUCT Skull Mount Kit A-1330, consisting of sterile gloves, PVP
solutions, small prep tray, razor, sponge gauze, towels, CSR
wraps, needles, zylocaine, syringe, scalpel, drape, tray,
skull ring, bone screws, screw driver, drill bit, and hand
drill. Recall #Z-964-4.
CODE Sterile lot #22063A, Kit lot #38027893.
MANUFACTURER Ohio Medical Instruments, Cincinnati, Ohio.
RECALLED BY Manufacturer, by telephone December 8, 1993. Firm-initiated
recall complete.
DISTRIBUTION Idaho.
QUANTITY 1 kit was distributed.
REASON The product had no sterilization validation.
_______________
PRODUCT Human Neonatal Kidney (HNK) Cell Cultures in tubes, 50 per
rack, living cell cultures for viral isolation procedures in
clinical virology labs. Recall #Z-973-4.
CODE Catalog #70-151-D, Lot #1C3503, 1C3493.
MANUFACTURER Whittaker Bioproducts, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by telephone December 18, 1991. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,380 units were distributed; firm estimates none remains on
the market.
REASON The device was contaminated with yeast.
_______________
PRODUCT Human Neonatal Kidney (HNK) Cell Cultures in tubes, 50 per
rack, living cell cultures for viral isolation procedures in
clinical virology labs. Recall #Z-974-4.
CODE Catalog #70-151-D, Lot #1C3568.
MANUFACTURER Whittaker Bioproducts, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by telephone December 27, 1991. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
-11- QUANTITY 1,995 units were distributed; firm estimates none remains on
the market.
REASON Device was contaminated with bacteria.
_______________
PRODUCT SeeQuence 2/Medalist Trial Contact Lenses, Not For Sale,
intended for use as trial lenses only, and remain on the
premises of the eye care practitioner. Recall #Z-977-4.
CODE Lot #I092336.
MANUFACTURER Bausch & Lomb, Inc., Contact Lens Division, Rochester,
New York.
RECALLED BY Manufacturer, by letter April 14, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 195 cartons were distributed between 12/20/93 and 3/25/94.
REASON While the blister packs are correctly labeled as -4.50
diopter, the cartons are mislabeled as -4.75 diopter.
_______________
UPDATE The catalog number and lot number for Baxter's Stratus
Ultra-Sensitive hTsH Enzyme Immunoassay Kits,
Recall #Z-893-4, should be Catalog No. B5700-44, Kit lots
Nos. KXTS-224M through KXTS-252M except for Lots KXTS-229M
and KXTS-252M and not catalog B5700, Kit lots KXS-24M
through KXTS-322M as erroneously stated in the June 15, 1994
Enforcement Report.
-12-
END OF ENFORCEMENT REPORT FOR JUNE 29, 1994. BLANK PAGES MAY FOLLOW.
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