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
04/01/1992
Recalls and Field Corrections: April 1, 1992
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: Vegetable Steaks, 4 ounces each, packaged 2 per package.
Recall #F-196-2.
Code: Not coded. All product distributed.
Manufacturer: Hannelore Enterprises Ltd., West Babylon, New York.
Recalled by: Manufacturer, by telephone December 8, 1991. Firm-
initiated recall complete.
Distribution: Nationwide.
Quantity: Approximately 19,930 packages were distributed; firm
estimates none remains on the market.
Reason: Product is contaminated with Listeria monocytogenes.
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-1-
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: Minute Maid brand Lemonade, in 16 fluid ounce cartons,
24 cartons per case. Recall #F-189-2.
Code: FEB22A, FEB26A, FEB24T, MAR09A, MAR18A, MAR18T.
Manufacturer: Coca-Cola Foods, Anaheim, California, and Paw Paw,
Michigan.
Recalled by: Coca-Cola Foods, Division of Coca-Cola Company,
Houston, Texas, by telephone February 10, 1991, followed
by visit. Firm-initiated recall complete.
Distribution: California, Illinois, Oregon, Utah, Washington state,
Wisconsin.
Quantity: 485 cases (24 cartons per case were distributed; firm
estimates none remains on the market.
Reason: Product contained sugar although the label claimed,
"no preservatives or sugar added."
----
Product: Orange Julius Compound in 2 pound bags, shipped in
cases holding about 46 pounds per case.
Recall #F-191-2.
Code: Lot numbers: 75090411168, 75100711173.
Manufacturer: Continental Colloids, Dixon, Illinois.
Recalled by: Orange Julius of America, Minneapolis, Minnesota, by
telephone February 5, 1992 and by letter February 26,
1992. Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 199 cases (23 bags per case) were distributed.
Reason: Product was contaminated with salmonella.
----
Product: Shrimp Scampi and Vegetables with Linguini in
Garlic-Herb Sauce. Recall #F-197-2.
Code: All lots.
Manufacturer: Kraft General Foods, Inc., Glenview, Illinois.
Recalled by: Manufacturer, by electronic mail March 6, 1992.
Firm-initiated recall ongoing.
Distribution: Colorado, Utah, Montana, Washington state, California,
Arizona, Oregon, Hawaii, Wyoming, South Dakota, Idaho,
Nevada.
Quantity: 50,227 cases (12 bags per case) were distributed.
Reason: Product contains small pieces of plastic.
----
-2-
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Bayou Cajun Country brand:
(a) Hot Sweet Cajun Pickles, 8 ounces;
(b) Spicy Sweet Cajun Pickles, 16 ounces;
(c) Spicy Sweet Cajun Relish, 8 ounces;
(d) Spicy Sweet Jalapeno Relish, 8 ounces.
Recall #F-175/178-2.
Code: None.
Manufacturer: Bayou Cajun Country, Inc., Monroe, Louisiana.
Recalled by: Manufacturer, by by letter January 29, 1992.
Firm-initiated recall ongoing.
Distribution: Louisiana, California, Texas, Michigan.
Quantity: (a) 38 12-unit cases; (b) 113 12-unit cases;
(c) 86 12-unit cases; (d) 21 12-unit cases were distributed.
Reason: Metal screw top lids are swelling.
----
Product: Marzetti brand Fat-Free Ranch Dressing in 8 ounce glass
bottles. Recall #F-190-2.
Code: Lot numbers 9/19/92, 9/25/92, 10/04/92, 10/08/92, 10/10/92.
Manufacturer: Pfeiffer Foods, Inc., Wilson, New York.
Recalled by: T. Marzetti Company, Columbus, Ohio, by letter
January 10, 1992. Firm-initiated recall ongoing.
Distribution: Michigan, Wisconsin, Ohio, New York, Missouri, Indiana, Iowa.
Quantity: 4,092 cases (12 bottles per case) were distributed; firm
estimates less than 205 cases remain on the market.
Reason: Product is contaminated with Lactobacillus bacteria.
----
Product: Hi-C Grape Drink, in 8.45 fluid ounce tetra brik packages.
Recall #F-192-2.
Code: Lot numbers: NOV2792SJ and NOV2792SI (package);
NOV2792SXX (case).
Manufacturer: Whitlock Packaging Company, Ft. Gibson, Oklahoma.
Recalled by: Coca-Cola Foods, Division of The Coca-Cola Company,
Houston, Texas, by visit January 10, 1992. Firm-
initiated recall complete.
Distribution: Oklahoma, Texas.
Quantity: 1,552 cases (27 packages per case) were distributed;
firm estimates none remains on the market.
Reason: Product was contaminated with yeast.
----
-3-
Product: Various baking foods items:
(a) H & K Wholewheat Bran Base, in 50 pound bags;
(b) Deluxe Dinner Roll Base, in 50 pound boxes;
(c) Wenner Soft Bun Base, in 50 pound boxes.
Recall #F-193/195-2.
Code: Lot numbers: (a) 2 101190, 2 120490;
(b) 1 82490, 2 82490, 3 82490, 1 41591, 2 41591;
(c) 1 51391, 162591, 2 62591, 1 62691, 3 71691,
2 72391, 3 72391, 1 72491, 2 72491, 3 72491, 4 72491,
5 72491, 6 72491, 1 72591, 2 72591.
Manufacturer: Puratos Corporation, Cherry Hill, New Jersey.
Recalled by: Manufacturer, by letter December 20, 1991. Firm-
initiated recall ongoing.
Distribution: (a) Massachusetts; (b) Florida, Illinois, Michigan,
Ohio, Oklahoma, Pennsylvania, Wisconsin, Puerto Rico.
(c) New York.
Quantity: (a) 80 bags; (b) 209 boxes; (c) 479 boxes were distributed.
Reason: Product contains undeclared saccharin.
----
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
NONE
Class III -
Product: Oxygen USP in E and D size tanks. Recall #D-277-2.
Code: All lots distributed in refillable tanks.
Manufacturer: Piedmont Medical Aids, Inc., Gaffney, South Carolina.
Recalled by: Manufacturer, by visit on or about March 5, 1992.
Firm-initiated recall complete.
Distribution: South Carolina.
Quantity: Approximately 21 tanks were distributed.
Reason: Current good manufacturing practice deficiencies.
----
Product: Calamine Lotion, in 4 and 8 ounce bottles, an OTC
topical drug. Recall #D-278-2.
Code: All lots in date.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter January 30, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide, Bahamas, Guam.
-4-
Quantity: 494,798 units were distributed; firm estimates 9,364
units remain on the market.
Reason: Product does not meet stability specifications.
----
Product: Prometh with Codeine, in 4 and 16 ounce bottles, a
Rx drug indicated for the temporary relief of cough
and upper respiratory symptoms associated with allergies
or the common cold. Recall #D-279-2.
Code: Lot #03659 EXP 06/92.
Manufacturer: Barre-National, Inc., Baltimore, Maryland.
Recalled by: Manufacturer, by letter January 30, 1992. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 128,861 units were distributed; firm estimates 24 units
remain on the market.
Reason: Subpotency of promethazine ingredient.
----
Product: Benztropine Mesylate Tablets, 0.5 mg, repacked into
unit dose containers. Recall #D-280-2.
Code: Lot numbers: 2547-018 9/92, 2547-019 10/92, 2547-020 10/92.
Manufacturer: Sidmak Laboratories, Inc., East Hanover, New Jersey.
Recalled by: Vangard Labs, Inc., Glasgow, Kentucky (repacker).
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Firm estimates 6,800 tablets remain on the market.
Reason: Product does not meet USP content uniformity
specifications.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Mandatory Recall -
Product: Century SAF-Lift, Model SL-10, Pin-Slot and Bar-Hook
Styles, used with the Century SAF-KARY Wheelchair as a
part of the Century Whirlpool Bathing System.
Recall #Z-316-2.
Code: All product manufactured prior to March 1990.
Manufacturer: Malmros Holding, Inc., Morton Grove, Illinois.
(Century Manufacturing Company, Aurora, Nebraska).
Recalled by: Manufacturer, by telephone beginning February 12, 1991
followed by letter beginning February 13, 1991.
FDA-ordered recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 28,500 units were distributed.
-5-
Reason: Mandatory 518(e) recall. There has been a high failure
rate where the SAF-KARY or SAF-LIFT chair may separate
unexpectedly from the SAF-LIFT during transfer of the
patient either in or out of the whirlpool bathing system.
----
Class I -
NONE
Class II -
Product: Concha Column, a disposable cartridge used in a heated
humidifier:
(a) Standard Concha-Column, Model numbers 382-70, 382-60,
385-70, 385-60;
(b) Low Compliance Concha-Column, Model numbers 382-20,
382-30, 385-20, 385-30. Recall #Z-394/395-2.
Code: Model No. Lot Nos.
382-60 B25160, B26160, B27160, B28160, C01160,
C04160, C05160, C06160, C07160, C08160, C20120
382-70 B06170, B22170, L26070, M11070, A02170, A21170
B07170, C11170, L27070, M12070, A03170, A22170
B08170, C12170, L28070, M13070, A04170, A23170
B09170, C13170, L29070, M14070, A07170, A24170
B11170, C14170, L30070, M15070, A08170, A25170
B12170, C15170, M01070, M17070, A09170, A28170
B13170, C18170, M03070, M18070, A10170, A29170
B14170, C19170, M04070, M19070, A11170, A30170
B15170, C20170, M05070, M20070, A14170, A31170
B18170, C21170, M06070, M21070, A15170, B01170
B19170, C22170, M07070, M26070, A16170, B02170
B20170, C25170, M08070, M27070, A17170, B04170
B21170, C26170, M10070, M28070, A18170, B05170
382-30 A02130, A11130, B12130, B27130, C11130, M10030
A03130, A14130, B13130, C01130, C12130, M11030
A04130, A15130, B14130, C04130, C13130, M12030
A07130, A16130, B15130, C05130, C14130, M13030
A08130, A17130, B25130, C06130, C15130, M14030
A09130, A18130, B26130, C07130, C25130, M17030
A10130, B11130, B27130, C08130, C26130, M18030
M19030, M20030, M21030
382-20 A21120, A22120, A23120, A24120, A25120, A28120
A29120, A30120, A31120, B01120, B02120, B04120
B04120, B05120, B06120, B07120, B08120, B18120
B19120, B20120, B21120, B22120, C18120, C19120
C20120, C21120, C22120, L02020, L03020, L05020
L05020, L06020, L07020, L08020, L09020, L12020
L13020, L14020, L15020, L16020, L19020, L20020
L21020, L26020, L27020, L28020, L29020, L30020
M03020, M04020, M05020, M06020, M07020
-6-
385-70 010291A, 010691A, 010791A, 011091A, 011391A
011491A, 012191A, 012291A, 013191A, 022191A
022291A, 022891A, 030191A, 030591A, 030691A
030891A, 031291A, 031991A, 032091A, 032691A,
040291A, 040891A, 040991A, C0690A, C1490A,
C1690A, C1790A, C2190A
385-60 040391A
395-30 010391A, 010791A, 011091A, 011591A, 011691A,
012391A, 012491A, 013091A, 022291A, 030191A,
030691A, 031391A, 032091A, 032691A, 032791A,
040591A, 040991A, C1890A
385-20 011091A, 011691A, 012491A, 012591A, 013191A,
020191A, 020491A, 020891A, 022291A, 030691A,
031491A, 032091A, 032191A, 032791A, 040391A,
040491A, 041091A, 041691A, B0890A, B1090A,
B1390A, B1490A, B2590A, C1290A, C1390A.
Manufacturer: Hudson Respiratory Care, Inc., Arlington Heights, Illinois.
Recalled by: Hudson Respiratory Care, Inc., Temecula, California, by
letter April 26, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 236,658 units were distributed.
Reason: The column may separate at the junction between the top
cap and the aluminum canister causing a potential for
gas leakage.
----
Product: Laser products used in lumber mills:
(a) Edger Optimizer; (b) Trimmer Optimizer;
(c) Shop Trimmer Optimizer; (d) Shop Edger Optimizer;
(e) Laser Green Trimmer Optimizer;
(f) Laser Green Edger Optimizer. Recall #Z-377/382-2.
Code: Serial numbers: N/A.
Manufacturer: Newness Automation, Inc., British Columbia, Canada
(Newness Automation, Inc. (USA), Columbus, Ohio.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan February 19, 1992. Firm-initiated field
correction ongoing.
Distribution: California, Oregon, South Carolina, Washington state.
Quantity: 13 units.
Reason: Noncompliance with the performance standard for laser
products in that they lacked a remote interlock connector,
beam attenuator, correct warning logotype label and
aperture label, and complete user instructions.
----
Product: Ambidextrous Latex Examination Gloves, small, medium,
and large. Recall #Z-419-2.
Code: None.
Manufacturer: Ansell, Inc., Tucson, Arizona.
Recalled by: Great Western Dental & Medical Supply, Tucson, Arizona,
by letter August 1, 1991. Firm-initiated recall ongoing.
Distribution: Arizona, New Mexico, California, Nevada, Texas.
-7-
Quantity: Approximately 1.2 million gloves were distributed.
Reason: The device failed the FDA leak test.
----
Product: Intersept Custom Tubing Pack, sterile, nonpyrogenic.
Recall #Z-420-2.
Code: Catalog No. Lot No Catalog No. Lot No.
2730 - 3 b1280 5006 - 2 b1289
2886 c1118 5990 - 4 b1153
5990 - 4 c1145 2017 c1023
5030 -1 c1344 2445 - 2 m0179
1149 c1149 1775 - 16 a1250
1775 - 16 b1250 1925 - 12 b1138
2773 - 3 m0009 2062 - 4 b1260
2452 - 5 c1148 2874 - 2 b1315
1842 - 10 c1079 2062 - 4 c1092.
Manufacturer: Medtronic Cardiopulmonary Division, Anaheim, California.
Recalled by: Manufacturer, by letter April 19, 1991 to sales force.
Firm-initiated recall ongoing.
Distribution: California, Minnesota, Nebraska, New York, Pennsylvania,
Ohio, Missouri.
Quantity: 426 units.
Reason: The sterility of the device may be compromised due to
defective pouch seal.
----
Product: Micro-Swab Strep, 10 and 30 tests per kit, for group A
strep detection. Recall #Z-421-2.
Code: Catalog #MS10 (10 patient), Catalog #MS30 (30 patient),
Lot #091192.
Manufacturer: Kubny Engineering Inc., Berkeley, California.
Recalled by: Dutton Company, Sudbury, Massachusetts, by letter dated
January 10, 1992. Firm-initiated recall ongoing.
Distribution: California, Massachusetts.
Quantity: 284 kits were distributed.
Reason: The device has been marketed without an approved
Premarket Approval Application (PMA).
----
Product: Shiley cuffed size 6 disposable cannula tracheostomy
tubes: (a) 6 DCT, Disposable Cannula Low Pressure
Cuffed Tracheostomy Tube;
(b) 6 DFEN, Disposable Cannula Fenestrated Low Pressure
Cuffed Tracheostomy Tube;
(c) 6 DPRV, Disposable Cannula Low Pressure Cuffed with
Pressure Relief Valve Tracheostomy Tube.
Recall #Z-428/430-2.
Code: Lot numbers: (a) 9100468900, 9100482600, 9100504800,
9100535600, 9100574700, 9100574800, 9100598900,
9100627200, 9100627300, 9100640600, 9100648400,
-8-
9100648500, 9100671900, 9100681800, 9100761300,
9100131800, 9100106100, 9100158800, 9100158900,
9100188500, 9100195500, 9100266200, 9100306100,
9100373100, 9100373200, 9100359200
(b) 9100477300, 9100533800, 9100597200, 9100625700,
9100670800, 9100760000, 9100153000, 9100306500,
9100360300
(c) 9100513000, 9100604600, 9100675900, 9100744800,
9100138300, 9100348000, 9100396000, 9100470900.
Manufacturer: Shiley, Inc., Irvine, California.
Recalled by: Manufacturer, by letters of September 23 and 30, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide, Australia, Canada, Japan, The Netherlands.
Quantity: 26,089 units were distributed.
Reason: The tubes may have a significant distortion of the
cannulae. The distortion is typically a bend to the
patient's right, which could cause increased pressure
on the wall of the trachea, with the potential for
tracheal stenosis and erosion of the innominate artery.
----
Product: ECG Lead Wire, Part #9235 to be used in conjunction with
the firm's "Omni-Trak" 3100 MRI Vital Signs Monitoring
System. Recall #Z-434-2.
Code: Part #9235.
Manufacturer: Invivo Research, Inc., Winter Park, Florida.
Recalled by: Manufacturer, by visit from sales representatives
beginning October 1990 followed by mailing of corrective
action package beginning January 31, 1991. Firm-initiated
field correction ongoing.
Distribution: Pennsylvania, Texas, Massachusetts, Ohio, Illinois,
Michigan, Mississippi, Maine, Minnesota, Vermont, Georgia,
Hawaii, Arizona, Missouri, Colorado, Washington, D.C.
Quantity: 25 units. were distributed.
Reason: The firm received reports that patients sustained first,
second and third degree burns when undergoing magnetic
resonance imaging.
----
Class III -
Product: Viral Transport Tissue Culture Based Medium, intended
to stabilize virus during transport to the laboratory
while controlling mycotic and bacterial overgrowth.
Recall #Z-435-2.
Code: Lot numbers: 1331 EXP 5/20/89, 1332 5/27/89.
Manufacturer: Baxter Diagnostics, Inc., Bartels Diagnostic Division,
Issaquah, Washington.
Recalled by: Manufacturer, by letter dated November 6, 1989 and sent
December 6, 1989. Firm-initiated recall complete.
Distribution: California, Wyoming, Texas, Massachusetts, Michigan,
Arizona, Ohio.
-9-
Quantity: 2,518 units were distributed; firm estimates none
remains on the market.
Reason: The device was shipped with the wrong expiration date
on the product.
----
Product: Bartels Transporter Viral Transport Medium, for
in-vitro diagnostic use. Recall #Z-436-2.
Code: Catalog #B1029-34, lot #1375.
Manufacturer: Baxter Diagnostics, Inc., Bartels Diagnostic Division,
Issaquah, Washington.
Recalled by: Manufacturer, by telephone during October 1990.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 1,022 units were distributed; firm estimates none
remains on the market.
Reason: Some transporters were contaminated with fungus.
Contamination was found in retention sample of media
used to re-feed the transporters.
----
Product: Clostridium Difficile Cytotoxicity Assay Kit,
#Catalog #B1029-70, used for qualitative detection of
Clostridium difficile toxins in patient samples by means of
cytotoxicity assay. The Toxi-Titer Diluent is the component
of this kit that is being recalled. Recall #Z-437-2.
Code: Catalog #B1029-70B (component).
Manufacturer: Baxter Diagnostics Inc./Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by telephone during the week of October 14,
1991, and by letter October 28, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 314 bottles were distributed.
Reason: Product is contaminated with bacteria.
----
Product: Anti-Influenza A Antibody used in the Viral
Respiratory Kit (VRK), used to detect virus strains.
Recall #Z-438-2.
Code: Catalog #B1029-87B, lot #1023. The antibody was used in
VRK lot number 1086, 1087, 1088, 1089, 1090, 1091, 1092.
Manufacturer: Baxter Diagnostics, Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by letter November 26, 1990. Firm-initiated
recall complete.
Distribution: Nationwide and international.
Quantity: 99 kits were distributed.
-10-
Reason: Some cross-staining occurred in the Influenza B well of the
Antigen control slide for the VRK which was stained with
Anti-Influenza A antibody lot #1023.
----
Product: McCoy Culture Cells MC-L, Catalog #B1029-9, Mouse
carcinoma, light density, used to enhance bacterial/
viral growth for detection purposes. Recall #Z-439-2.
Code: Lot #1547 split JL/D.
Manufacturer: Baxter Diagnostics Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by telephone October 15, 1991. Firm-
initiated recall complete.
Distribution: Nationwide.
Quantity: 592 units were distributed; firm estimates none remains
on the market.
Reason: Product is contaminated.
----
Product: McCoy Culture Cells MC-L, Catalog #B1029-9, Mouse
Carcinoma, Light Density, used to enhance bacterial/
viral growth for detection purposes. Recall #Z-440-2.
Code: Lot #1470 Split TAC.
Manufacturer: Baxter Diagnostics Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by telephone April 25, 1990. Firm-
initiated recall complete.
Distribution: Nationwide.
Quantity: 388 units were distributed; firm estimates none
remains on the market.
Reason: Bacterial/yeast contamination was detected in product.
----
Product: Bartels McCoy Culture Cells MC Mouse Carcinoma, used
to enhance virus/bacteria growth for detection
purposes. Recall #Z-441-2.
Code: Catalog numbers B1029-8 or B1029-9, lot #1435.
Manufacturer: Baxter Diagnostics Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by letter August 23, 1989. Firm-
initiated recall complete.
Distribution: Nationwide.
Quantity: 4,614 vials were distributed; firm estimates none
remains on the market.
Reason: Cell contamination.
----
-11-
Product: McCoy Vials, used to enhance bacteria/virus growth
for detection purposes. Recall #Z-442-2.
Code: Catalog #B1029-8, lot #1433.
Manufacturer: Baxter Diagnostics Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by telephone during August 1989.
Firm-initiated recall complete
Distribution: Nationwide.
Quantity: 647 units were distributed; firm estimates none
remains on the market.
Reason: Yeast/bacterial contamination.
----
Product: Human Foreskin (HF) Vials, used to enhance virus/bacteria
growth for detection purpose. Recall #Z-443-2.
Code: Catalog #B1029-2, lot #1546.
Manufacturer: Baxter Diagnostics Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by telephone during August 1990.
Firm-initiated recall complete.
Distribution: Nationwide.
Quantity: 256 vials were distributed; firm estimates none
remains on the market.
Reason: Firm discovered a double population cell type in QA
retentions of HF vials split AAA.
----
Product: MRC-5 Vials containing tissue culture cells.
Recall #Z-444-2.
Code: Catalog #1029-16B, lot #1354.
Manufacturer: Baxter Diagnostics Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by telephone during February 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 423 vials were distributed.
Reason: Bacterial contamination.
----
Product: A549 Lung Carcinoma Cells, used to enhance the growth
of viruses for detection purposes. Recall #Z-445-2.
Code: Catalog #B1029-73, lot #1216.
Manufacturer: Baxter Diagnostics Inc., Bartels Diagnostics Division,
Issaquah, Washington.
Recalled by: Manufacturer, by letter March 8, 1991. Firm-initiated
recall complete.
Distribution: Nationwide.
Quantity: 2,260 tubes were distributed; firm estimates none remains
on the market.
-12-
Reason: Bacterial contamination.
----
Product: Quinton Quick-Prep Electrode, Part #11408-005,
Size 2, used for obtaining ECG recordings during stress
testing. Recall #Z-504-2.
Code: Lot #060591N1.
Manufacturer: Quinton Instrument Company, Seattle, Washington.
Recalled by: Manufacturer, by telephone August 28, 1991, followed by
letter August 30, 1991. Firm-initiated recall ongoing.
Distribution: New Jersey, Florida, California, North Carolina, Arizona,
Alabama.
Quantity: 6,150 electrodes were distributed.
Reason: Five percent of the product could exhibit a greater
impedance than manufacturing requirements allow.
High impedance causes unstable traces on the ECG
monitor.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: Monarch Division Protek Teat Dip Germicidal Pre and Post
Milking Teat Dip in 1 gallon and 15 gallon containers;
Bou-Matic Super Dip Germicidial Full Strength Teat Dip, in
1 gallon and 15 gallon containers. Recall #V-025-2.
Code: Batch code 01025.
Manufacturer: H.B. Fuller Company, Monarch Division, Minneapolis,
Minnesota.
Recalled by: Manufacturer, by telephone February 28, 1992 and
March 2, 1992, followed by letter March 6, 1992.
Firm-initiated recall ongoing.
Distribution: Illinois, Iowa, Kansas, Maryland, Michigan, Minnesota,
Wisconsin, North Dakota, South Dakota.
Quantity: 1,320 1-gallon and 20 15-gallon containers were distributed.
Reason: Product is contaminated with bacteria.
----
Class III -
Product: Oxytetracycline Type A medicated articles, for use in
poultry for the prevention of early mortality due to
organisms susceptible to Oxytetracycline, for use in
swine as an aid in the maintenance of weight gains and
feed consumption in the presence of atrophic rhinitis; and
for use in cattle for prevention and treatment of early
stages of shipping fever complex:
-13-
(a) OXTC 100, Oxytetracycline 22%;
(b) OXTC 50, Oxytetracycline 11%;
(c) DURVET OXTC 50, Oxytetracycline 11%. Recall #V-024-2.
Code: (a) 0C014H09-0C022H09, 0C037H09-0C078H09, 0C101H09-0C108H09
0C133H09-0C141H09, 0C092H09-0C197H09, 0C241H09-0C245H09
0C001H19-0C008H19, 0C032H19-0C088H19
(b) 0L023H09-0L032H09, C-0L021H09-C-0L032H09
(c) C-0L001H19-C-0L016G19, C-0L021H09-C-0L032H09.
Manufacturer: Smithkline Beecham Animal Health, Omaha, Nebraska.
Recalled by: Manufacturer, by telephone and by letter February 24, 1992.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: (a) 14,608 bags; (b) 1,311 bags; (c) 3,268 bags were
distributed.
Reason: Bulk oxytetracycline used in manufacture of Type A
medicated article was from an unapproved manufacturing
source.
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Medical Device Safety Alerts:
Product: Specific IVAC Check Valve IV Solution Administration
Sets. Safety Alert #M-035-2.
Code: Lot numbers: C20087, C20806, C20809, C20812, C20829,
C20830, C50025, C50043, C50046, C50051, C50052, C50058,
C50064, C50066, C50068, C50084, C50089, C50094, C50115,
C50860, C59040, C59090, C70016, C80008, C80009, C80042,
C80043, C80047, C80048, 52043, 52343, 82043.
Manufacturer: IVAC Corporation, San Diego, California.
Alerted by: Manufacturer, by letter April 11, 1991.
Distribution: Nationwide.
Quantity: 721,237 sets were distributed.
Reason: During the application of a secondary medication or
fluid, when using an IVAC set containing a check valve
in the y-site, the primary line may also flow, which
could result in overinfusion.
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Product: Bird Volume Ventilators, electrically powered microprocessor
controlled, volume cycled, pressure limited critical care
ventilator designed for both adult and pediatric
application: (a) Model #8400ST; (b) Model 84ST.
Safety Alert #M-036/037-2.
Code: All serially numbered units.
Manufacturer: Bird Products Corporation, Palm Springs, California.
Alerted by: Manufacturer, by letter January 14, 1991.
Distribution: Nationwide and international.
Quantity: (a) 3,155 units; (b) 676 units were distributed.
Reason: The flow control valve may stick in the closed position
which prevents flow of breathing gases to the patient.
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Product: O.R. SARAcap with the Plus Option, a respiratory monitor
and capnograph, designed for use during surgery and general
anesthesia to monitor airway
levels of carbon dioxide, oxygen, and nitrous oxide.
Safety Alert #M-038-2.
Code: All serial numbers.
Manufacturer: PPG Industries, Inc., Biomedical Systems Division,
Lenexa, Kansas.
Alerted by: Manufacturer, by letter November 26, 1991.
Distribution: Nationwide and international.
Quantity: 4,000 units were distributed.
Reason: The performance of the device may be disrupted by
electromagnetic interference (EMI) from electrosurgery
units (ESUs).
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Seizure Actions Filed:
Product: Sterile Gauze Sponges and Catheter Trays (91-610-936).
Charge: Adulterated - Products were held under insanitary conditions
whereby they may have been rendered injurious to health
because of the presence of orthodichlorobenzene, a potent
chemical irritant.
Firm: Super Cartage, Chicago, Illinois.
Filed: March 6, 1992 - U.S. District Court for the Northern
District of Illinois; Civil #92 C 1651, FDC #66367.
Seized: March 10, 1992 - goods valued at $90,000.
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Mass Seizure:
Product: Various Foods (91-614-402).
Charge: Adulterated - Products consist in part of a filthy substance
in that they have been held under insanitary conditions
whereby they may have become contaminated with filth.
Firm: Westlake Noodle Company of Houston, Houston, Texas.
Filed: May 29, 1991 - U.S. District Court for the Southern
District of Texas; Houston Division; Civil #H-91-1505,
FDC #66168.
Seized: June 10, 1991; 10,000 pounds, valued at $29,000.
Disposition: February 24, 1992 - Reconditioned seized goods, and
goods valued at $1,900 were destroyed.
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