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
10/02/1991
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.
Product: Uneviscerated frozen salted, yellow croaker fish.
Recall #F-549-1.
Code: None.
Manufacturer: Rhee Bros., Inc., Columbia, Maryland.
Recalled by: Manufacturer, by letter August 19, 1991, followed by
telephone. Firm-initiated recall ongoing.
Distribution: Maryland, Virginia, New York, Pennsylvania, South
Carolina, North Carolina, Delaware, Florida.
Quantity: 225 cartons (20 packages per carton) were distributed.
Reason: Potential Clostridium botulinum toxin hazard.
----
-1-
Product: Bufarella brand ricotta cheese, 6.6 pounds each, 8 pieces
per carton. Recall #F-567-1.
Code: None.
Manufacturer: Italfresh, Ltd., Port Chester, New York.
Recalled by: Manufacturer, by telephone July 11, 1991, followed
by letter. Firm-initiated recall ongoing.
Distribution: New York, Florida.
Quantity: 168 pieces were distributed.
Reason: Product distributed without FDA release while under
automatic detention due to Listeria monocytogenes
contamination.
----
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: Chews Grape Bubble Gum, sold in 19 gram plastic bags.
Recall #F-428-1.
Code: NONE.
Manufacturer: Leaf Confections Ltd., Toronto, Ontario, Canada.
Recalled by: Tomas Diaz Inc., Miramar, San Juan, Puerto Rico, by
telephone, followed by letter. Firm-initiated recall
ongoing.
Distribution: Puerto Rico and the Caribbean.
Quantity: 493 cases (12 boxes per case and 48 packages per box)
were distributed.
Reason: Product is contaminated with staphylococcal enterotoxin
and contains undeclared FD&C Yellow No. 5.
----
Product: Coca-Cola Classic Fountain Syrup, in 5 gallon containers.
Recall #F-505-1.
Code: N18 07-24-91.
Manufacturer: Coca-Cola USA, Nashua, New Hampshire.
Recalled by: Manufacturer, by telephone August 8, 1991, followed by
letter August 12, 1991. Firm-initiated recall ongoing.
Distribution: New York, New Hampshire, Maine, Connecticut, New Jersey,
Massachusetts.
Quantity: 2.874 5-gallon containers were distributed; firm
estimates 50% remains on the market.
Reason: Product mislabeled as Diet Coke.
----
Product: Immun-Aid, a medical food to support the metabolic
and immune system needs of patients experiencing
catabolic stress. Recall #F-559-1.
-2-
Code: Catalog #A3015, lot numbers: F0S075 EXP 12/92,
F1A409 EXP 1/93, F1A410 EXP 1/93, F1A411 EXP 1/93.
Manufacturer: McGaw of Puerto Rico, Inc., Sabana Grande, Puerto Rico.
Recalled by: McGaw, Inc., Irvine, California, by letter April 4, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 430 cases (24 units per carton) were distributed; firm
estimates that little product remains on the market.
Reason: The product is superpotent in potassium.
----
CORRECTION: Sundor Brands Sunny Delight Florida Citrus Punch,
Recall #F-529-1, which appeared in the September 18, 1991,
Enforcement Report, should read: Code: Lot #NOV 07L.
----
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Hi-C Hula Punch, in 8.45 fluid ounce containers, labeled
to contain 100% U.S. RDA of Vitamin C per serving.
Recall #F-492-1.
Code: Package code: JUN 2692HH, Case code: 0734-0954HJUN 2692 GH.
Manufacturer: Coca-Cola Bottling Company, Hightstown, New Jersey.
Recalled by: Coca-Cola Foods, Houston, Texas, by telephone August 12,
1991, followed by letter August 16, 1991. Firm-initiated
recall complete.
Distribution: Pennsylvania, New York.
Quantity: 72 cases (9 3-packs per case) were distributed; firm
estimates none remains on the market.
Reason: Product is low in Vitamin C.
----
Product: Hi-C and Minute Maid brand of beverages in 8.45 fluid
ounce packages:
(a) Hi-C Stompin Banana Berry;
(b) Hi-C Double Fruit Cooler;
(c) Hi-C Orange;
(d) Hi-C Hula Punch;
(e) Hi-C Jammin Apple;
(f) Minute Maid Orange;
(g) Minute Maid Apple Juice;
(h) Minute Maid Fruit Punch. Recall #F-550/557-1.
Code: Case Code Package Code
(a) MAR 06 92 MAR0692DA
(b) MAY 06 92 MAY0692DA
-3-
(c) MAR 04 92 MAR0492DA
MAR05 92 MAR0592DA
MAR 06 92 MAR0692DA
(d) JUL 12 92 JUL1292DA
(e) JUL 13 92 JUL1392DA
(f) JAN 09 92 JAN0992DA
(g) APR 06 92 APR0692DA
APR 07 92 APR0792DA
(h) APR 08 92 APR0892DA
Manufacturer: Coca-Cola Bottling Company, Auburndale, Florida.
Recalled by: Coca-Cola Foods, Houston, Texas, by visit beginning
August 2, 1991. Firm-initiated recall complete.
Distribution: Alabama, Florida, Georgia, Louisiana, North Carolina,
South Carolina, The Bahamas.
Quantity: 27,067 cases (27 packs per case) were distributed.
Reason: Product contained in leaking containers.
----
Product: D'Sol Vitamin D3 Dairy Concentrate, in 300 cc, 500 cc,
and 2000 cc plastic bottles, used in the fortification
of milk. Recall #F-558-1.
Code: Lot #11065.
Manufacturer: Freeman Industries, Inc., Tuckahoe, New York.
Recalled by: Manufacturer, by letter July 9, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 158 2000-cc bottles, 276 500-cc bottles and 24 300-cc
bottles were distributed.
Reason: Product was mislabeled as vitamin D2.
----
Product: Vitamin products, in 50 ml bottles used for the
supplementation of the diet with essential vitamins
and with fluoride for caries prophylaxis, under the
Schein and Major label and also distributed unlabeled:
(a) Multi Vit Drops with Fluoride 0.25 mg;
(b) Multi Vit Drops with Fluoride 0.5 mg;
(c) Multi Vit Drops with Fluoride & Iron;
(d) Tri Vit Drops with Fluoride 0.25 mg;
(e) Tri Vit Drops with Fluoride 0.5 mg;
(f) Tri Vit Drops with Iron & Fluoride;
(g) Multi Vit Drops. Recall #F-560/566-1.
Code: Lot numbers: (a) 03184 EXP 6/92, 03186 EXP 8/92,
03651 EXP 10/92;
(b) 92712 EXP 11/91, 03188 EXP 6/92, 03461 EXP 8/92;
(c) 03460 EXP 7/92, 03891 EXP 1/93, 03084 EXP 2/93;
(d) 03199 EXP 7/92, 03201 EXP 7/92, 03575 EXP 9/92;
(e) 92645 EXP 11/91, 03674 EXP 9/92;
(f) 03462 EXP 7/92, 03667 EXP 10/92, 13035 EXP 2/93;
(g) 03427 EXP 6/92.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
-4-
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: 506,352 units were distributed; firm estimates 215,252
units remain on the market.
Reason: Product is subpotent in Vitamin C content.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: C-Solve-2 Erythromycin Topical Solution 2%, in 1 ounce
and 2 ounce units. Recall #D-646-1.
Code: Lot numbers: G509 G729 G768 G854
G510 G730 G769 G855
G511 G713 G777 G858
G702 G732 G792 G863
G705 G733 G795 G872
G710 G734 G796 G922
G716 G735 G813 G954
G717 G746 G815 G992
G725 G749 G816 H001
G726 G757 G819 H026
G727 G758 G827 H029
G728 G763 G834.
Manufacturer: Syosset Laboratories Co., Inc., Syosset, New York.
Recalled by: Manufacturer, by telephone July 15, 1991, followed
by letter July 19, 1991. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 281,180 units were distributed.
Reason: Potency not maintained through expiration date.
----
Product: Lorazepam C IV Tablets 0.5 mg, in bottles of 100,
500 and 1000 tablets, a Rx Class IV control drug indicated
for the management of anxiety disorders and for the short
term relief of the symptoms or anxiety associated with
depression, under the Bioline and Goldline labels.
Recall #D-647-1.
Code: Lot numbers: 89H465, 89K554, 89M659, 89M660, 90B050,
90B051, 90E148, 90F183, 90G206, 90H239, 90K291, 91A009,
91A010, 91C089, 91E163.
-5-
Manufacturer: Superpharm Corporation, Central Islip, New York, and
Superpharm Corporation, Bayshore, New York.
Recalled by: Superpharm Corporation, Bayshore, New York, by letter
July 11, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,848,000 tablets of lot 89H465, 1,688,100 of lot
89K554, 1,861,100 tablets of lot 89M659, 1,820,000
tablets of lot 89M660, 1,815,800 tablets of lot 90B050,
1,908,000 tablets of lot 90B051, 1,908,000 tablets of
lot 90E148, 1,830,000 tablets of lot 90F183, 1,897,400
tablets of lot 90G206, 1,907,500 tablets of lot 90H239,
1,930,500 tablets of lot 90K291, 1,889,400 tablets of
lot 91A009, 1,940,500 tablets of lot 91A010, 1,933,500
tablets of lot 91C089, 99.6 kg in blend stage of lot
91E163 was distributed.
Reason: Lack of assurance of bioequivalence and Abbreviated
New Drug Approval discrepancies.
----
Product: (a) Cephadrine 250 mg Capsules (amber colored);
(b) Cephadrine 500 mg Capsules (pink colored),
a cepholosporin antibiotic, single ingredient, Rx drug,
for human use, packaged in aluminum foil blister unit
dose and in 100 capsule bottles, under the Zenith,
Genetco, Mason Distributors, Parmed and Aligen Independent
Laboratories labels. Recall #D-650/651-1.
Code: Lot numbers: (a) 4063-516, 4063-517, 4063-518,
4063-519, 4063-520, 4063-521, 4063-521B, 4063-522;
(b) 4064-120, 4064-121, 4064-122, 4063-123, 4063-124,
4063-125, 4063-126, 4064-127, 4064-128, 4064-129,
4064-130, 4064-131.
Manufacturer: Pralex Corporation, Christiansted, St. Croix, U.S.
Virgin Islands.
Recalled by: Zenith Laboratories, Inc., Northvale, New Jersey
(responsible firm), by telephone September 17, 1991,
followed by letter. Firm-initiated recall ongoing.
Distribution: Unknown.
Quantity: Firm estimates 9,000 bottles remain on the market.
Reason: Potency not assured through expiration date.
----
Class III -
Product: Aluminum Hydroxide gel, in 1 gallon bottles, an
OTC product used to temporarily relieve heartburn,
sour stomach and/or acid indigestion. Recall #D-648-1.
Code: Lot #72700 EXP 2/92.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
-6-
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: 853 gallons were distributed; firm estimates none
remains on the market.
Reason: Product fails stability specifications.
----
Product: Iophen Solution, in 30 ml bottles, a Rx product used
for adjunctive treatment as a mucolitic-expectorant in
respiratory tract conditions. Recall #D-649-1.
Code: All lots within expiration dates.
Manufacturer: Barre-National, Baltimore, Maryland.
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Jamaica, Haiti, Guam, The Bahamas, Mexico.
Quantity: 161,675 bottles were distributed.
Reason: Lack of assurance that product meets stability
specifications through expiration date.
----
CORRECTION: Recall #D-644/645-1, Cefizox Viaflex Plus, which appeared
in the September 25, 1991, Enforcement Report, should
read: Firm-initiated field correction ongoing.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
EXTENSION NOTE: Reflex Model 8220 Multiprogrammable SSIC Pulse Generator
with Telemetry, Recall #Z-646-1 has been extended to
include an additional 52 units which were not identified by
the firm during its original assessment of units affected
by this recall. This brings the number of units
distributed to 1,656.
----
Class II -
Product: Model 7100 Direct 30/30 Blood Glucose Sensor, a diagnostic
instrument described as an enzyme-electrode sensor
designed specifically for pocket-portable self-monitoring
of blood glucose. Recall #Z-1034-1.
Code: All serial numbers.
Manufacturer: Electronic Assembly Corporation, Neenah, Wisconsin.
Recalled by: ELCO Diagnostics Company, Division of Eli Lilly and
Company, Indianapolis, Indiana, by letters of June 14, 1991,
and July 15, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
-7-
Quantity: 5,302 units were distributed.
Reason: The product performance may lead to inaccurate readings
or inability to obtain any reading. This could lead to
a delay or error in diagnosis of a problem and treatment.
----
Product: Model AD-1 Beam-Limiting device (BLD), used for
mammography. Recall #Z-1051-1.
Code: Serial numbers: 001 - 021.
Manufacturer: AR Custom Medical Products, Ltd., Deer Park, New York.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan August 16, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 21 units were distributed.
Reason: Noncompliance with the performance standard for x-ray
products in that the company did not provide adequate
information to the assemblers, as required in 21 CFR
1020.30(g), to ensure that when installed, the systems
would meet the requirements of 21 CFR 1020.30(m)(1),
half-value layer.
----
Product: Futurus 2001 R/F X-Ray Generator and Control.
Recall #Z-1070-1.
Code: Serial numbers: 1001, 1025, 1037, 1040, 1041.
Manufacturer: Acoma Medical Imaging, Inc., Wheeling, Illinois.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan September 3, 1991. Firm-initiated field
correction ongoing.
Distribution: Florida, Missouri, Ohio, Wisconsin.
Quantity: 5 units were distributed.
Reason: Noncompliance with the performance standard for x-ray
products in that indication of current during
fluoroscopic use was not correct (did not give a value).
----
Product: Helium-Neon Laser System. Recall #Z-1071-1.
Code: Serial numbers: Undetermined.
Manufacturer: IBM Corporation Research Triangle Park, North Carolina.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan September 3, 1991. Firm-initiated field correction
ongoing.
Distribution: Illinois.
Quantity: 25 units were distributed.
Reason: Noncompliance with performance standard for laser
products in that the laser systems were assembled using
components salvaged from obsolete scanners and were not
certified.
----
-8-
Product: Model LBS Industrial Laser Marker. Recall #Z-1072.
Code: Serial numbers: Undetermined.
Manufacturer: AB Lasers, Acton, Massachusetts.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan September 3, 1991. Firm-initiated field correction
ongoing.
Distribution: Massachusetts.
Quantity: 1 unit was distributed.
Reason: Noncompliance with the performance standard for laser
products in that a service switch was provided which
could permanently defeat required interlocks, and user
instructions failed to contain all required information.
----
Product: Shampaine RADI-OP Operating Room Tables:
(a) Model 1700RC; (b) Model 1800RC; (c) Model 1900RC;
(d) Model 4800E; (e) Model 4900. Recall #Z-1079/1083-1.
Code: All serial numbers.
Manufacturer: Smith & Nephew Shampaine/Wilson, St. Louis, Missouri.
Recalled by: Manufacturer, by mailing safety notices dated April 9,
1991 and May 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide, Canada, Mexico, West Indies.
Quantity: Approximately 850 tables were distributed.
Reason: The control pendant and foot switch may experience an
electrical problem from water leaking through the
seal between the pendant cord and the connector.
This could cause the table to move improperly.
----
Product: CDI flow thru cells, component of the CDI Model 300
Extracorporeal Blood Gas Monitor:
(a) Model 6635, 3/8";
(b) Model 6645, 1/2". Recall #Z-1084/1085-1.
Code: Lot numbers: (a) 11216, 11217, 11218, 11219, 11338, 11478,
11481, 11482, 11827, 11982, 11502, 11503, 11504, 11505,
11539, 11540, 11594, 11595, 11679, 11680, 11681, 11708,
11709, 11710, 11711, 11777, 11778, 11828, 11933, 11984,
11985, 12080, 12081, 12187, 12334, 12335, 12336, 12374,
12375, 12376, 12481, 12482, 12483, 12946, 12947, 13149,
13196, 13197;
(b) 8156R, 8277R, 8292R, 8293R, 8512, 8652, 8654, 8690,
8791, 8792, 8910, 8911, 8999, 9000, 9008, 9037, 13151.
Manufacturer: CDI / 3M Healthcare, Tustin, California.
Recalled by: Manufacturer, by letter May 14, 1991. Firm-initiated
recall ongoing.
Distribution: California, Puerto Rico.
Quantity: (a) 5,697 units; (b) 1,019 units were distributed.
Reason: Some of the devices may leak at the bond between the cell
housing and membrane support, compromising sterility of
the product.
----
-9-
Product: Catheter System, Balloon Type, for dilatation and
recanalization; shaft size 5.8F, usable length 90 cm.
Recall #Z-1087-1.
Code: Catalog #70064, lot #882004 EXP 5/18/94.
Manufacturer: Meadox Surgimed A/S, Stenlose, Denmark.
Recalled by: Meadox Surgimed, Inc., Oakland, New Jersey, by
telephone and by letter July 26, 1991. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: 19 kits were distributed.
Reason: Some of the kits (packages) may lack sealing at the
end flap which may compromise the sterility of the product.
----
Product: Amsco Spordi Strips, biological spore strips which
are being used in chemiclaves (chemical vapor sterilizers),
to determine the adequacy of the sterilization process.
Recall #Z-1091-1.
Code: All lots promoted for use in chemiclaves.
Manufacturer: Amsco Medical Products Division, Erie, Pennsylvania.
Recalled by: OSU-Sterilization Monitoring Service, Columbus, Ohio,
by letter July 1, 1991. Firm-initiated recall ongoing.
Distribution: Ohio, Alaska, Kentucky, New York.
Quantity: Unknown.
Reason: Product was illegally marketed without 510(k) approval.
----
Product: Broxodent Automatic Action Toothbrush, for cleaning
human teeth. Recall #Z-1092-1.
Code: Catalog #250/89/25003. All units including 6EX7906 to
OCX7223.
Manufacturer: Tanoro SA, Sion, Switzerland.
Recalled by: Somerset Labs, Division of Bristol Myers/Squibb,
Michigan City, Indiana, and Clairol Products, New
York, New York, by letter February 1991.
Newspaper announcements were published in January and
February 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: Approximately 13,032 units were distributed to
Canada and approximately 200,000 distributed in the
United States.
Reason: Users may receive electric shocks from the device if the
cord insulation is compromised.
----
Product: Wheelchair Cushions: (a) The Jay Cushion;
(b) The Jay Active Cushion; (c) The Jay Protector.
Recall #Z-1094/1096-1.
-10-
Code: All serial numbers beginning with 080, 090, 100, 110,
120, 011, 021, 031. This represents cushions produced
between August 10, 1990 and March 27, 1991.
Manufacturer: Jay Medical, Ltd., Boulder, Colorado.
Recalled by: Manufacturer, by letter August 20, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 33,068 cushions were distributed.
Reason: A preservative used in the flolite pads in the
cushions may cause a rash or irritation to the
patients skin.
----
Product: AEZ Pin and Ligature Cutter, used in dentistry:
(a) Model/Part #803-0502;
(b) Model/Part #803-0503;
(c) Model/Part #803-0504;
(d) Model/Part #803-0505. Recall #1097/1100-1.
Code: Model/Part nubers: 803-0502, 803-0503, 803-0504,
803-0505.
Manufacturer: Ormco Corporation, Glendora, California.
Recalled by: Manufacturer, by letter December 17, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 1,775 units were distributed.
Reason: The tip may fall off due to inadequate strength caused
by poor design.
----
Product: Hydrajust X-Ray Tables:
(a) Model IAFSX-GE; (b) Model IAFXR-GE;
(c) IATKS-GE; (d) IATXR-GE. Recall #Z-1101/1104-1.
Code: All serial numbers.
Manufacturer: General Electric Company, Milwaukee, Wisconsin.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan September 10, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide and international.
Quantity: 162 units were distributed.
Reason: Noncompliance with the performance standard for
x-ray products due to limitation of useful beam.
----
Product: Aequitron Medical, Inc., Model 8200CE Infant
Respiration/Heart Rate Monitor, Rx devices used
to detect and alarm in the event of low or high
rates, and apnea. Recall #Z-1105-1.
Code: Serial numbers 101,000 through 113,113.
Manufacturer: Aequitron Medical, Inc., Minneapolis, Minnesota.
-11-
Recalled by: Manufacturer, by letter September 23, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide, Canada, Belgium.
Quantity: 12,100 monitors were distributed.
Reason: The product exhibits a sensitivity to electromagnetic
interference (EMI) which could cause a failure to
alarm in the event of apnea.
----
Product: Peacock Tanning System 1600-CS series Model 160-C
16 lamp suntanning booth. Recall #Z-1106-1.
Code: Various.
Manufacturer: Avex Industries, Ltd., Hudson Falls, New York.
Recalled by: Manufacturer, by letter on or about September 2, 1991,
and by telephone September 3, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 86 units were distributed.
Reason: Noncompliance with performance standard for suntan
products in that the electronic timers may fail
to shut off.
----
Product: ConstaVac Blood Conservation System (CBC) Product
#215-28, used as an autologous blood reinfusion
system and closed wound drainage system.
Recall #Z-1107-1
Code: Lot numbers: 10912196 and 10912196A.
Manufacturer: Stryker Corporation, Kalamazoo, Michigan.
Recalled by: Manufacturer, by telephone and letter January 8, 1990.
Firm-initiated recall complete.
Distribution: Iowa, California, Idaho, Indiana, Michigan, Missouri,
Nebraska, New Jersey, Ohio, Pennsylvania, Texas.
Quantity: 17 cases were distributed.
Reason: The pouch that the device is sealed in is incorrectly
labeled as a 215-87, 800 cc Reservoir Kit.
----
Class III -
Product: Sterile Catheter Injection Sealing Caps, used to
provide a self-sealing injection site for administering
medications through luer-lock catheter connections.
Recall #Z-1067-1.
Code: Lot #407130.
Manufacturer: Quinton Instrument Company, Seattle, Washington.
Recalled by: Manufacturer, by telephone July 12, 1991 followed by
letter July 15, 1991. Firm-initiated recall ongoing.
Distribution: Michigan, North Carolina, New York, Indiana, Florida,
Oklahoma, Connecticut, California, Japan.
Quantity: 125 cartons (50 caps per carton) were distributed;
firm estimates 420 caps remain on the market.
-12-
Reason: The cards labeling incorrectly identifies the product as
BETA-CAP clamps.
----
Product: ConstaVac Blood Conservation System (CBC), Product #215-28,
used as an autologous blood reinfusion system and closed
wound drainage system. Recall #Z-1108-1.
Code: Lot numbers 10901002 through 10908170, except for lots
10906127, 10906130 and 10906132.
Manufacturer: Stryker Corporation, Surgical Instruments Division,
Kalamazoo, Michigan.
Recalled by: Manufacturer, by letter August 28, 1989. Firm-initiated
recall complete.
Distribution: Nationwide, Hong Kong.
Quantity: 502 cases (6 units per case) were distributed.
Reason: The device might develop an air leak and allow air to
bubble through the blood when the blood is being collected
under suction.
----
Product: Bact/Alert Anaerobic Culture Bottles, used with the
Bact/Alert Microbial Detection System to determine
if microorganisms are present in blood samples taken
from patients suspected of having bacteremia/fungemia.
Recall #Z-1090-1.
Code: Product #59269. Lot #101534 EXP 3/92.
Manufacturer: Organon Teknika Corporation, Durham, North Carolina.
Recalled by: Manufacturer, by telephone July 16, 1991 followed by
letter July 17, 1991. Firm-initiated recall ongoing.
Distribution: Alabama, Florida, Georgia, Illinois, Kentucky, New York,
Ohio, Tennessee, Belgium, Canada, France, Italy,
The Netherlands, Spain, Sweden, Switzerland.
Quantity: 260 cases (100 bottles per case) were distributed;
firm estimates 130 cases remain on the market.
Reason: Random bottles contain a C02 sensor membrane which
exceeds the established color specifications. When
these bottles are placed in Bact/Alert instrument, the
bottle may not be recognized by the instrument.
----
VETERINARY PRODUCTS
NONE
Medical Device Safety Alerts:
Product: Star Exhalation Isolation Systems:
(a) Model 505001; (b) Model 505003;
(c) Model 505004; (d) Model 505005;
(e) Model 505006; (f) Model 505007;
(g) Model 505008; (h) Model 505015.
Safety Alert #M-040/047-1.
-13-
Code: All serial numbers for all units distributed between
1/10/85 through 9/4/90 which begin with serial number
18AB018 and with serial number 57669-070.
Manufacturer: Infrasonics, Inc., San Diego, California.
Alerted by: Manufacturer, by letters of September 18 and 24, 1990.
Distribution: Arkansas, Arizona, California, Colorado, Florida,
Georgia, Illinois, Kansas, Louisiana, Massachusetts,
Maryland, Michigan, Minnesota, New Jersey, New Mexico,
New York, Ohio, Pennsylvania, Tennessee, Texas, Utah,
Puerto Rico, Australia, Canada, Greece, Japan, Mexico,
Singapore, Taiwan.
Quantity: 3,300 units were distributed.
Reason: Products may contain blocked filters and failed heating
resistors.
----
Product: Ivion/Valleylab IV5000/IV6000/IV6006 Volumetric
Infusion Pump Receptacle, a component of the Volumetric
Infusion Pump which provides controlled gravity flow of
medications to the patient. Safety Alert #M-048-1.
Code: All serial numbers.
Manufacturer: Ivion Corporation, Broomfield, Colorado.
Alerted by: Manufacturer, by letter August 21, 1991.
Distribution: Nationwide and international.
Quantity: Approximately 2,500 units were distributed. Firm
estimates 1 percent of the units in the market may
still have the "old" receptacle.
Reason: If a newly designed cassette is used in an IV5000,
IV6000 or IV6006 Volumetric Infusion Pump with fixed
actuators ("old" receptacle), the possibility exists that
the IV set would free flow when in the pump.
----
Product: Zoll PD-1200 Pacemaker/Defibrillator.
Safety Alert #M-049-1.
Code: Serial numbers 1000 through 2171.
Manufacturer: ZMI Corporation, Woburn, Massachusetts.
Alerted by: Manufacturer, by letter May 21, 1991.
Distribution: Nationwide and international.
Quantity: 1,171 units were distributed.
Reason: The defibrillation paddles for adult use may be
installed incorrectly, in the reversed direction,
resulting in the lack of electrical connection and no
defibrillation energy transferred to the patient.
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