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.
October 23, 1996 96-43
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Horton's Naturally Smoked Atlantic Salmon,
packaged in 4 ounce vacuum sealed plastic
bags. Recall #F-017-7.
CODE 212136 USE BY 9/04.
MANUFACTURER Horton's Downeast Foods, Inc., Waterboro,
Maine.
RECALLED BY Manufacturer, by telephone on September 17,
1996. Firm-initiated recall complete.
DISTRIBUTION Connecticut, Illinois, Massachusetts, Maine,
North Carolina, New Hampshire, New York, Ohio,
Vermont.
QUANTITY 67 pounds were distributed; firm estimates
none remains on the market.
REASON Product was contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Nestle Strawberry Quick Powdered Drink Mix, in
16 ounce tin boxes. Recall #F-010-7.
CODE 5093CN.
MANUFACTURER Nestle Enterprises, Chesterville, Ontario,
Canada.
RECALLED BY Nestle Beverage Company, San Francisco,
California, by letter August 23, 1996. Firm-
initiated recall complete.
DISTRIBUTION Georgia, Pennsylvania, Indiana.
QUANTITY 8,550 cases were distributed; firm estimated
that little if any product remained on market
at time of recall initiation.
REASON Product contained wood fragments.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT "The Golden Pole" chocolate covered wafer bar,
12 and 14 ounces, product of Poland.
Recall #F-011-7.
CODE BN 86/8094/03.
MANUFACTURER Cukiernicza Spoldzielnia Pracy, Poland.
RECALLED BY Eastern Star Distributing Company, Inc.,
Brooklyn, New York, by letter August 23, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 1,285 cartons were distributed; firm estimates
none remains on the market.
REASON The specific source of fat and oil (rapeseed)
is not listed in the ingredient statement.
_______________
PRODUCT Best Choice Marshmallow Fudge Cookies, in 12
ounce cellophane packages. Recall #F-012-7.
CODE All product in distribution bearing the
incorrect nutrient facts panel.
MANUFACTURER Interbake Foods, Inc., Richmond, Virginia
(responsible firm).
RECALLED BY Associated Wholesale Grocers, Inc., Kansas
City Kansas, via "satellite" followed by
letter on September 11, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 3,000 12-package cases were
distributed.
REASON The nutrition facts panel of the product is
incorrect.
_______________
PRODUCT Viking Bakery Muffins:
(a) Corn Muffins, 14 ounces;
(b) Bran Muffins, 12 and 14 ounces;
(c) Blueberry Muffins, 12 ounces.
Recall #F-013/015-7.
-2-CODE Sell by dates of AUG 28 for product
manufactured 8/22/96 and AUG 29 for product
manufactured 8/23/96.
MANUFACTURER Operative Cake Company, doing business as
Viking Cake Company, West Hartford,
Connecticut.
RECALLED BY Operative Cake Company, Long Island City, New
York and Automated Bread, Brentwood, Long
Island, New York, on August 23, 1996.
Completed recall resulted from FDA/State of
Connecticut contract inspection.
DISTRIBUTION New York.
QUANTITY (a) 552 retail units; (b) 264 retail units;
(c) 96 retail units were distributed; firm
estimates none remains on the market.
REASON Products were contaminated with rodent filth
and were prepared, packaged, and held under
insanitary conditions.
_______________
PRODUCT Minute Maid Premium Calcium-Rich Orange Juice,
in 128 ounce plastic bottles, 96 ounce plastic
bottles and 64 ounce paper cartons.
Recall #F-016-7.
CODE 128 ounce plastic bottles:
Lot Number:
Container: BEST BEFORE OCT 10, A XX:XX
BEST BEFORE OCT 16, A XX:XX
BEST BEFORE OCT 17, A XX:XX
Shipping Case: XX:XX A OCT 10 A40575C
XX:XX A OCT 16 A40676C
XX:XX A OCT 17 A40649D
96 ounce plastic bottles:
Lot Number:
Container: BEST BEFORE OCT 15, A XX:XX
BEST BEFORE OCT 16, A XX:XX
Shipping Case: XX:XX A OCT 15 A40650B
XX:XX A OCT 16 A40650B
64 ounce paper cartons:
Lot Number:
Container: XX:XX OCT 10 A1
XX:XX OCT 10 A2
XX:XX OCT 15 A1
XX:XX OCT 15 A2
XX:XX OCT 16 A1
XX:XX OCT 16 A2
XX:XX OCT 17 A1
XX:XX OCT 17 A2
-3- Shipping Case: XX:XX A OCT 10 A 40445B
XX:XX A OCT 10 A 40445C
XX:XX A OCT 15 A 40644B
XX:XX A OCT 15 A 40644C
XX:XX A OCT 16 A 40644B
XX:XX A OCT 16 A 40644C
XX:XX A OCT 17 A 40766C
XX:XX represents a 24-hour time.
MANUFACTURER Coca-Cola Foods, Anaheim, California.
RECALLED BY Coca-Cola Foods, Houston, Texas, on September
23, 1996, followed by visit on or before
September 23, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION California and Arizona.
QUANTITY 24,350 cases were distributed.
REASON Product has an off-flavor.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============
_______________
UPDATE Recall #D-254-6, Adrenal Cortex Injection,
which appeared in the October 16, 1996
Enforcement Report, should read as follows:
_______________
PRODUCT All sizes and strengths of ADRENAL CORTEX
INJECTION, a Rx injectable drug, labeled as
distributed by Hallmark Labs, Chicago, IL.
Recall #D-254-6.
CODE All codes (most units are uncoded).
MANUFACTURER (primary) Ontor Beauty Products, Inc., Opa
Locka, Florida.
RECALLED BY Phyne Pharmaceuticals, Inc., Scottsdale,
Arizona (own-label distributor); by letter
mailed October 1, 1996. Firm-initiated;
ongoing. See also FDA press release P96-13,
August 30, 1996.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Mycobacterium abscessus contamination of
unopened vial of Hallmark Labs' labeled
product distributed by Phyne Pharmaceuticals
and epidemiological data collected by CDC
correlating the use of this product with
Mycobacterium abscesses at the site of
injection.
RECALLS AND FIELD CORRECTIONS -- DRUGS -- CLASS III =========
_______________
PRODUCT Merck's Aquamephyton (Vitamin K) for
Injection, 10 mg/ml, in 2.5 ml and 5 ml vials,
indicated for use in the treatment of
-4- prophylaxis and treatment of hemorrhagic
disease of the newborn; anticoagulant-induced
prothrombin deficiency in adults;
hypoprothrombinemia due to other causes in
adults. Recall #D-006-7.
CODE Lot numbers: 1255A EXP 12/31/96, 0208B EXP
2/28/97, 0226B EXP 5/31/97.
MANUFACTURER Merck Manufacturing Division, Division of
Merck and Company, Inc., West Point,
Pennsylvania.
RECALLED BY Manufacturer, by letter on October 10, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates that 10,000 market packages
remained on market at time of recall
initiation.
REASON Product may be subpotent due to the stopper
absorbing the active ingredient.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Gemini PC-1 Volumetric Infusion
Pump/Controller, European 220 Volt Model
V8.12. Recall #Z-001-7.
CODE 645 units with individual serial numbers.
MANUFACTURER IMED Corporation, San Diego, California.
RECALLED BY Manufacturer, by letter dated June 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION International.
QUANTITY 645 units were distributed.
REASON The pumps contain a faulty toroid (inductor)
which may heat up adjacent wires causing an
electrical short.
_______________
PRODUCT Max-I-Probe Endodontic Irrigation Syringe:
(a) Catalog # MAXE125, 3cc syringe, 25G probe,
1-2% NaOC1 solution
(b) Catalog # MAXE625, 3cc syringe, 25G probe,
4-6% NaOC1 solution
(c) Catalog # MAXE628, 3cc syringe, 28G probe,
4-6% NaOC1 solution
(d) Catalog # MAXE630, 3cc syringe, 30G probe,
4-6% NaOC1 solution
(e) Catalog # MAXE650, trial kit of 2 trays--
1 tray of 3cc syringes and 1 tray of 10cc
syringes, with each tray containing 1- 25G,
-28G and 2-30G probes, with 4-6% NaOC1
solution
(f) Catalog # MAXE825, 3cc syringe, 25G probe,
2-3% NaOC1 solution
-5- (g) Catalog # MAXE828, 3cc syringe, 28G probe,
2-3% NaOC1 solution
(h) Catalog # MAXE830, 3cc syringe, 30G probe,
2-3% NaOC1 solution. Recall #Z-007/014-7.
CODE Lot numbers: (a) 96G13; (b) 96G01; (c)
96G03; (d) 96G05; (e) 96G001; (f) 96G07; (g)
96G09; (h) 96G11.
MANUFACTURER MPL Technologies, Inc., Franklin Park,
Illinois.
RECALLED BY Manufacturer, by letter September 9, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Belgium.
QUANTITY 12,455 syringes were distributed.
REASON The external finger grip flanges may separate
from the barrel of the syringe, rendering the
syringe inoperable.
_______________
PRODUCT Lifesaver Portable Oxygen Units, Catalog No.
5000, indicated for delivery of approximate
low, medium and high concentrations of oxygen.
Recall #Z-017-7.
CODE Serial numbers:
MHG9411 MHG9412 MHG9502 MHG9505
-0006 -0017 -0014 -0002
-0009 -0018 -0016 -0006
-0011 -0020 -0017 -0065
-0053 -0042 -0027 -0068
-0054 -0028 -0075
-0055 -0029 -0076
-0057 -0030 -0077
-0059 -0078
-0096.
MANUFACTURER Hudson Respiratory Care, Inc., Temecula,
California.
RECALLED BY Manufacturer, by telephone on June 14, 1996,
followed by letter on June 18 and 19, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION California, Texas, Illinois, Pennsylvania,
Utah, Missouri, Massachusetts, Canada,
Honduras.
QUANTITY 42 units were distributed.
REASON Device was distributed with a regulator with a
flow range of 1-8 LPM, instead of the correct
regulator with a flow range of 2-15 LPM.
_______________
PRODUCT The ThAIRapy Vest Airway Clearance System,
used to provide airway clearance therapy.
Recall #Z-018-7.
CODE Serial numbers: 31-00001 through 31-00173.
-6-MANUFACTURER American Biosystems, Inc., St. Paul,
Minnesota.
RECALLED BY Manufacturer, by field correcting products
beginning on or about February 8, 1996. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 173 devices were distributed.
REASON A shorting in an output transistor could allow
the device blower to operate at pressures
higher than specification, resulting in vest
pressures constricting the thorax and
impairing inspiration.
_______________
PRODUCT Low Porosity Woven Vascular Prosthesis,
Catalog #OLP1206, indicated for replacement or
bypass procedures in aneurysmal and occlusive
disease of the abdominal aorta, visceral
arteries and proximal peripheral arteries
exclusive of the coronary arteries. Recall
#Z-019-7.
CODE SERIAL NUMBERS LOT NOS.
3053001 94K18
3053003 94K18
3053007 94K18
3053008 94K18
3053009 94K18
3095001 92K09
3095002 92K09
3095003 92K09
3095004 92K09
3095005 92K09
3095006 92K09
3095007 92K09
3095008 92K09
3095010 92K09
3100603 92J18
3100604 92J18
3100608 92J18
3210201 92K02
3210203 92K02
3210204 92K02
3210205 92K02
3210206 92K02
3210207 92K02
3210208 92K02
3210209 92K02
3285301 93E21
3285302 93E21
3285304 93E21
3285306 93E21
3285307 93E21
-7- 3285308 93E21
3286301 93C26
3286302 96E17
3286303 96E17
3286304 93C26
3286307 93C26
3286309 93C26
3414701 93E21
3414702 93E21
3414703 93E21
3414706 93E21
3414709 93E21
3436101 93F30
3436404 93F30
3436409 96E17
3436410 96A10
3458903 96E17
3458906 93D30
3458907 93D30
3529702-3529708 95K13
3550001-3550004 94M16
3551001-3551010 95M01.
MANUFACTURER Intervascular Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by telephone on August 21, 1996,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION Tennessee, New York, Louisiana, Illinois,
Alabama, Florida, California, Pennsylvania,
Arizona, Georgia, Texas, New Jersey, Ohio,
Japan.
QUANTITY 65 unimplanted devices were in commerce at
time of recall initiation.
REASON One thread is missing in the involved woven
vascular prothesis which may potentially
increase water permeability along the line of
the pulled thread.
_______________
PRODUCT Input PS Catheter Introducer Sheath with
Hydro/pel Coating, used to facilitate placing
a catheter through the skin into a vein or
artery:
(a) 5F
1000511 5F 11 CM Input 2 (Freeway)
050011 5F 11 cm Input Introducer Intl.
055011 5F 11 cm Input Introducer
063311 5F 11 cm Input II Introducer
553311 5F 11 cm Input Introducer Intl
853311 5F 11 cm Input Introducer
FC4631951 5F Grey Input II Assembly
-8- (b) 6F
1000611 6F 11 cm Input 2 (Freeway)
060011 6F 11 cm Input Introducer Intl.
063312 6F 11 cm Input II Introducer
065011 6F 11 cm Input Introducers
563311 6F 11 cm Input Introducer Intl.
863311 6F 11 cm Input Introducer
1000623 6F 23 cm Input 2 (Freeway)
060023 6F 23 cm Input Introducer kit.
063317 6F 23 cm Input II Introducer kit
FC4631952 6F Green Input II Assembly
(c) 7F
1000711 7F 11 cm Input 2 (Freeway)
063313 7F ll cm Input II Introducer
070011 7F 11 cm Input Introducer Intl.
075011 7F 11 cm Input Introducer
573311 7F 11 cm Input Introducer Intl.
873311 7F 11 cm Input Introducer
1000723 7F 23 cm Input 2 (Freeway)
063318 7F 23 cm Input 2 Introd. Kit
070023 7F 23 cm Input Introducer Kit
FC4631953 7F Orange Input II Assembly
(d) 8F
080011 8F 11 cm Input Introducer Intl.
085011 8F 11 cm Input Introducers
080023 8F 23 cm Input 2 (Freeway)
583311 8F 11 cm Input Introducers Intl.
883311 8F 11 cm Input Introducer
063314 8F 11 cm Input II Introducer
063319 8F 11 cm Input II Introducer kit
1000823 8F 23 cm Input 2 (Freeway)
1000811 8F 11 cm Input 2 (Freeway)
FC4631954 8F Blue Input II Assembly
(e) 9F
063320 9F 23 cm Input 2 Introducer Kit
090023 9F 23 cm Input Introducer Kit
063315 9F 11 cm Input II Introducer
090011 9F 11 cm Input Introducer Intl.
095011 9F 11 cm Input Introducers
593311 9F 11 cm Input Introducer Intl.
893311 9F 11 cm Input Introducer
FC4631955 9F Grey Input II Assembly.
Recall #Z-020-024-7.
CODE All lot numbers of product produced since May
1995.
MANUFACTURER C.R. Bard Irl., Ballybrit, Galway.
RECALLED BY USCI Manufacturing Facility, Billerica,
Massachusetts, by letter on August 13, 1996,
and by telephone and interoffice mail. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
-9-QUANTITY Approximately 980,539 units were distributed.
REASON Introducer hub is separating at or near the
weld site of the upper and lower hub body
parts. Failure could result in significant
blood loss or air embolism.
_______________
PRODUCT Microvision-C Radiographic Film, used for
mammography. Recall #Z-027/028-7.
CODE Product is identified by Type, Emulsion #, Run
#, and Cut#:
GROUP A
TYPE EMULSION RUN CUT SIZE STOCK#
597 6042 0038 ALL 18X24 529567
0050 ALL 18X24 529567
0054 ALL 18X24 529567
597 6052 0034 ALL 18X24 529567
0035 ALL 18X24 529567
0075 ALL 18X24 529567
597 6062 0034 ALL 24X30 52963A
0035 ALL 18X24 529567
0035 01-07 24X30 52963A
21-26
0036 03-07 18X24 529567
0036 01,02 24X30 52963A
0037 ALL 18X24 529567
0048 ALL 24X30 52963A
0069 03-07 18X24 529567
0069 01,02 24X30 52963A
597 6072 0078 ALL 18X24 529567
(b) GROUP B
TYPE EMULSION RUN CUT SIZE STOCK#
597 6052 0036 ALL 18X24 529567
597 6062 0027 03-07 18X24 529567
0027 01,02 24X30 52963A
0032 ALL 18X24 529567
0051 ALL 24X30 52963A
0059 ALL 18X24 529567
0068 03-07 18X24 529567
0068 01,02 24X30 52963A
0070 ALL 24X30 52963A
0071 03-07 18X24 529567
0071 01,02 24X30 52063A
0072 03-07 18X24 529567
21-26
0072 01,02 24X30 52963A
0073 03,07 18X24 529567
0073 01,02 24X30 52963A
0076 ALL 24X30 52963A
0077 03-07 18X24 529567
0077 01,02 24X30 52963A
597 6072 0046 ALL 24X30 52963A
0049 ALL 24X30 52963A.
-10-MANUFACTURER Sterling Diagnostic Imaging, Inc., Brevard,
North Carolina.
RECALLED BY Sterling Diagnostic Imaging, Inc., Newark,
Delaware, by letter dated August 30, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Mexico, Brazil, Latin America.
QUANTITY Firm estimated that 19,388 boxes of film
remained on market at time of recall
initiation.
REASON The devices have demonstrated uncharacteristic
aging, that is below working limits for speed
for this product, which may result in the
mis-diagnosis in mammography readings.
_______________
UPDATE Invacare Oxygen Concentrators Mobilaire III/V,
and Invacare III/V Oyxgentrators, Recall #Z-
1216/1219-6, which appeared in the September
25, 1996 Enforcement Report, should read as
follows:
_______________
PRODUCT (a) Mobilaire III Oxygen Concentrator, Model
No. IRC301;
(b) Mobilaire V Oxygen Concentrator, Model No.
IRC501; (c) Invacare V Oxygen Concentrator,
Model No. IRC 50102, with optional Oxygen,
Purity Indicator. Recall #Z-1216/1218-6.
CODE Serial Numbers 96B46257-94B46706, 96B99247-
96B99265 and 96B50320-96B50916 which
corresponds to all of the involved devices
manufactured from 1/30/96 to 2/27/96.
MANUFACTURER Invacare Corporation, Sanford, Florida.
RECALLED BY Manufacturer, by telephone on March 8, 1996,
and October 4, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 193 units were distributed.
REASON Kinked oxygen transfer hoses in the units
caused by defective exterior foam insulation
may affect the flow of oxygen, and therefore,
affect the concentration of oxygen the patient
receives.
-11-
END OF ENFORCEMENT REPORT FOR OCTOBER 23, 1996. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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