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
10/23/1990
FDA Enforcement for the week of October 24, 1990
FDA ENFORCEMENT REPORT
FOR OCTOBER 24, 1990
October 24, 1990
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: Del Monte brand French Style Sliced Green Beans, in
16 ounce cans. Recall #F-681-0.
Code: 0201J6F82 as one-line ink jet code on can bottom.
Manufacturer: Del Monte Corporation, Markesan, Wisconsin.
Recalled by: Del Monte Corporation, Walnut Creek, California, by
telephone August 29, 1990. Firm-initiated recall complete.
Distribution: Connecticut, Delaware, New Jersey, New York, Pennsylvania.
Quantity: 843 cases (24 cans/case) were distributed.
Reason: Potential Clostridium Botulinum toxin hazard.
----
NOTE: Mt. Olive brand Fresh Kosher Dill Pickles, in 1
gallon glass jars, Recall #F-609-0 which appeared in
the October 10, 1990 Enforcement Report is a completed
recall.
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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.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: (a) Sugar-Free Almond Butter Crisp Candy, packaged in
4 pound boxes; (b) Sugar-Free Almond Bark Candy, packaged
in 5 pound boxes. Recall #F-686/687-0.
Code: (a) Product #451700, lot #OC01 and #2B06;
(b) Product #452400, lot #2D95.
Manufacturer: American Confectionery Company, Chino, California.
Recalled by: The Sweetery, Minneapolis, Minnesota, by letter dated
August 10, 1990 or by telephone during week of
August 27, 1990. Firm-initiated recall complete.
Distribution: Iowa, Minnesota, North Dakota, South Dakota.
Quantity: Approximately (a) 25 boxes; (b) 22 boxes were distributed.
Reason: Product is insect infested.
----
Product: Kiko Maple Syrup, packaged in 24 fl ounce polyethylene
containers. Recall #F-699-0.
Code: Not coded.
Manufacturer: Kiko, Inc., New Orleans, Louisiana.
Recalled by: Manufacturer, by telephone on or about August 21, 1990.
Firm-initiated recall ongoing.
Distribution: Louisiana.
Quantity: 120 cases were distributed.
Reason: Imitation-flavored maple syrup not labeled as such.
----
Product: Tetley Iced Tea Sweetened and with Natural Lemon Flavor,
packed in 12 ounce aluminum cans. Recall #F-706-0.
Code: K022N.
Manufacturer: Royal Crown Bottling of Virginia, Norfolk, Virginia.
Recalled by: Manufacturer, by contacting sales personnel August 29
and 30, 1990. Firm-initiated recall ongoing.
Distribution: Virginia, North Carolina.
Quantity: 72,360 cans were distributed.
Reason: Product contains undeclared added saccharin.
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Product: Nature's Formula Aloe Vera Drinks:
(a) Nature's Formula Spirits Natural Juice with Aloe
Herbal & Beta carotene, in 10-2/3 fluid ounce plastic
bottles, packaged 24 bottles per case and in eight 4-packs
per case (32 bottles);
(b) Nature's Formula Aloe Herbal Liquid Formula, in
32 fluid ounce plastic bottles packed 12 per case and
in 64 fluid ounce bottles packed 8 bottles per case.
Recall #F-715/716-0.
Code: Lot numbers: (a) 9187, 9193, 9197, 9211, 9212, 9216,
9227, 9234, 9236, 9254;
(b) 9182 (32 oz.), 9206 (32 & 64 oz.)
9183 (64 oz.), 9218 (32 & 64 oz.)
9188 (32 & 64 oz) 9250 (32 & 64 oz)
9198 (32 & 64 oz) 9256 (32 & 64 oz).
Manufacturer: Aloe Vera Trading Company, Dallas, Texas.
Recalled by: Manufacturer, by memorandum June 18, 1990. Firm-initiated
recall ongoing.
Distribution: Arizona, California, Colorado, Florida, Indiana,
Maryland, Mississippi, New York, Ohio, Texas, Washington
state, Wisconsin.
Quantity: 34,776 bottles (10-2/3 oz), 2,880 bottles (32 oz),
and 1,880 (64 oz) bottles were distributed.
Reason: Mislabeled - High fructose corn syrup substituted for honey.
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COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: Chewable Aspirin for Children, Orange Flavored Tablets,
an OTC product in bottles of 1,000. Recall #D-080-1.
Code: Lot numbers: 90E008 EXP 5/92, 90F007 EXP 6/92, 90G002
EXP 9/92.
Manufacturer: Advance Pharmaceutical, Inc., Ronkonkoma, New York.
Recalled by: Manufacturer, by letter August 28, 1990. Firm-initiated
recall ongoing.
Distribution: New York, Florida, New Jersey, California, Illinois.
Quantity: 416 bottles were distributed.
Reason: Product packaged in containers greater than 36 tablets
each.
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-3-
Product: Platelets. Recall #B-001-1.
Code: Unit #04K02810.
Manufacturer: American Red Cross-NE Region, Dedham, Massachusetts.
Recalled by: Manufacturer, by telephone February 12 and 16, 1990.
Firm-initiated recall complete.
Distribution: Maine, Massachusetts.
Quantity: 1 unit was distributed.
Reason: Platelets from donor who developed signs and symptoms
of viral infection, within 24 hours of donation, were
distributed.
----
Product: (a) Red Blood Cells; (b) Cryoprecipitated AHF;
(c) Recovered Plasma. Recall #B-008/010-1.
Code: Unit #13C54414.
Manufacturer: American Red Cross Blood Services, Detroit, Michigan.
Recalled by: Manufacturer, by telephone on or about June 22, 1988.
Firm-initiated recall complete.
Distribution: Michigan.
Quantity: 1 unit of each component was distributed.
Reason: Blood components, from a donor who previously tested
repeatably reactive for the human immunodeficiency
virus, type 1 (anti-HIV-1), were distributed.
----
Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-014/016-1.
Code: Unit numbers: (a) 38F92740, 38F95049, 38H07576, 38M12547;
(b) 38F92740, 38F95049, 38J11428;
(c) 38F92740, 38F95049, 38H07576, 38M12547.
Manufacturer: American Red Cross, Fort Wayne, Indiana.
Recalled by: Manufacturer, by letters of June 22, 1990, August 14 and
22, 1990. Firm-initiated recall ongoing.
Distribution: Indiana, California, Illinois, Ohio.
Quantity: (a) 4 units; (b) 3 units; (c) 4 units were distributed.
Reason: Blood products which tested non-reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1) but were collected from donors who
previously tested repeatably reactive for anti-HIV-1,
were distributed.
----
Class III -
Product: Oxygen USP, Medicinal Gas, packed in green steel C, D and
E size cylinders, an Rx product. Recall #D-082-1.
Code: Lot #121-9003 and Serial numbers: 702, 736, 795, 811,
946, 10105, 10111, 10132.
Manufacturer: Tri-County Oxygen and Medical Supplies, Inc., Brooksville,
Florida.
Recalled by: Manufacturer, by visit on or about September 2, 1990.
Firm-initiated recall complete.
-4-
Distribution: Florida.
Quantity: 13 units were distributed; firm estimates none remains
on the market.
Reason: Failure to test purity.
----
Product: Baxter Fenwal Plasmacell-C Disposable Plasma Collection
Bag with In-line Anticoagulant drip chamber.
Recall #B-002-1.
Code: Lot numbers: 9001 through 9365, 0001 through 0151.
Manufacturer: Baxter Healthcare Corporation, Fenwal Division,
Deerfield, Illinois.
Recalled by: Manufacturer, by letter June 25, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Unknown. All products manufactured between January 1,
1988 and June 25, 1990.
Reason: Possibly adulterated with plastic shavings (particulate
matter).
----
MEDICAL DEVICES AND RADIOLOGY
Class I -
NONE
Product: Enema Administration Kits with Latex Retention Cuffs:
(a) Enema Tips with Inflatable Cuffs sold for
attachment to Enema Kits, such as the Miller Air
Retention Tip;
(b) Enema Tips with Inflatable Cuffs attached to Empty
Enema Bags, such as the Super XL Enema Kit;
(c) Enema Tips with Inflatable Cuffs attached to
prefilled Barium Enema Bags. Recall #Z-932/934-0.
Code: All lots of the following E-Z-EM products:
Filled/unfilled Enema Kits-Catalog Numbers:
110/ 416/ 1316/ P650PP
112/ 420/ 2212 P650PPK
114/ 510/ 2216/
116/ 512/ 910/
310/ 514/ 920/
312/ 516/ 930/
314/ 520/ 935/
316/ 524/ 925S
318/ 812/ 925K
320/ 816/ 925/
1312/ M25
M25K
M20
-5-
Retention Cuff Enema Tip-Catalog Numbers:
913 915 931 932
933 934 938 939
940 955 966 9308
9317 9309 9325 9301
9310 9328 9302 9311
9335 9305 9314 9336
9306 9315 9338 9307
9316 9345
All lots of the following Lafayette Model numbers
(Filled/unfilled enema bags and unit dose kits):
1112 6616 1260 4404 1837
1116 6642 1802 1840
1117 1815 1805 1841
1120 1197 1806 1835 1842
1125 1242 1811 1836 1844.
All lots of Enterocylsis Catheters-Catalog Numbers
ET412, 5510, 5563.
Manufacturer: E-Z-EM Inc., Westbury, New York.
Recalled by: E-Z-EM Inc., Westbury, New York or Lafayette Division
of E-Z-EM, Inc., Lafayette, Indiana, by letter October 8,
1990. Firm-initiated recall ongoing. See also FDA Talk
Paper T90-49, October 15, 1990.
Distribution: Nationwide and international.
Quantity: Firm estimates between 110 and 150 thousand units remain
on the market.
Reason: In some cases the devices may trigger an allergic reaction
causing injury or possible death if not treated in time.
----
Class II -
Product: BRT 2001 and BRT 2010 Laser Bar Code Scanners, used
for inventorying warehouse stock. Recall #Z-888-0.
Code: Serial numbers: Model 2001 - 11028701; Model 2010 - 07158701
07158702, 02258901, 03258701, 03038701, 03038702,
01298701, 01298702, 01168601, 01168602, 09308701,
09308702, 09308703, 09308704, 10018701, 10018702,
11248601, 11248602, 08028601, 08028602, 04218602,
08158601, 02199003, 02108601, 06048701, 08248701.
Manufacturer: BRT Corporation, Doylestown, Pennsylvania.
Recalled by: Manufacturer, by letter October 19, 1990. Firm-initiated
field correction ongoing.
Distribution: Connecticut, Delaware, Florida, New Jersey, Pennsylvania,
Utah, Wisconsin.
Quantity: 1 unit of model 2001 and 23 units of model 2010 were
distributed.
Reason: Noncompliance with performance standards for laser
products in that labeling and user manuals were inadequate.
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Product: Orient brand latex gloves:
(a) "Sterile" Surgical Gloves; (b) "Non-sterlie"
Examination Gloves, all sizes, 12 pairs per unit,
pre-powdered, use once. Recall #Z-007/008-1.
Code: No codes listed on inner carton. Individual packages:
Size 6, batch (lot) No 880071, EXP 8/91; Size 6 1/2,
batch (lot) No. 880073 EXP 8/91.
Manufacturer: Orient Medical Supply Company, Ltd., Seoul, Korea.
Recalled by: Surgix, Inc., Ronkonkoma, New York, by letter August
28, 1990. Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 205 master cartons with 42 inner cartons of 12 pairs each.
Reason: (a) "Sterile" glove packets had partially incomplete pack
seals which would compromise the sterility of the product;
(b) The gloves failed FDA leak test.
----
Product: Tourniquet Cuff Pressure Monitors, used to restrict
blood flow in patient's arm or leg during surgery:
(a) Model TCPM; (b) Model Medi-Quet 2740.
Recall #Z-010/011-1.
Code: All lots and serial numbers:
Manufacturer: Electromedics, Inc., Englewood, Colorado.
Recalled by: Manufacturer, by letter September 6, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Turkey, Italy.
Quantity: (a) 188; (b) 630 units were distributed.
Reason: A limited number of units may have been manufactured with
an incorrect microprocessor timing chip that will cause
the device to show incorrect time by allowing the unit
to show 99 minutes on the visual display before changing
to 1:00 hour.
----
Product: Single Patient 480 Dialysis Delivery Systems, except
High Flow and TUEV Models:
(a) Standard 480 (non UF Control): Acetate, Bicarbonate,
and Variable Sodium;
(b) Ultrafiltration Control 480s: Acetate, Bicarbonate, and
Variable Sodium;
(c) 480 Dialysate control Spare Modules: Non UF Control,
UF Control. Recall #Z-012/014-1.
Code: Lot numbers:
(a) Acetate Bicarbonate Variable Sodium
N480A-0A0 N480B-0A0 N480V-1A0
N480A-1AR N480B-1A0 N480V-1AR
N480A-1A0 N480B-1AR N480V-1B0
N480A-1BR N480B-1B0 N480V-1BR
N480A-1B0 N480B-1BR N480V-1C0
N480A-1CR N480B-1C0 N480V-1CR
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N480A-1C0 N480B-1CR N480V-1D0
N480A-1DO N480B-1D0 N480V-2A0
N480A-2A0 N480B-1DR N480V-2AR
N480A-3A0 N480B-2A0 N480V-3A0
N480A-5A0 N480B-2AR N480V-5A0
N480B-3A0
N480B-5A0
(b) Acetate Bicarbonate Variable Sodium
N485A-1A0 N485B-0A0 N485V-0A0
N485A-1AR N485B-1A0 N485V-1A0
N485A-1B0 N485B-1AR N485V-1AR
N485A-1BR N485B-1B0 N485V-1B0
N485A-1C0 N485B-1BR N485V-1BR
N485A-1CR N485B-1CO N485V-1C0
N485A-2A0 N485B-1CR N485V-1CR
N485A-3A0 N485B-1D0 N485V-1D0
N485A-5A0 N485B-2A0 N485V-2A0
N485B-2AR N485V-2AR
N485B-3A0 N485V-3A0
N485B-5A0 N485V-5A0
(c) For lot numbers beginning with M1... through M9
and MA... through MB13560.
Non UF Control UF Control
N-1004-0E-00 N1104-4FS
N-1004-0F-00 N-1004-0E-UF
N-1004-0F-02 N-1004-0F-UF
N112A-4E0 N113A-4E0
N-1104-RE-00 N-1104-RE-UF.
Manufacturer: CD Medical, Inc., Subsidiary of the Dow Chemical Company,
Portland, Oregon.
Recalled by: Manufacturer, by letter August 20, 1990. Firm-initiated
field correction ongoing.
Distribution: Nationwide and international.
Quantity: 6,233 machines/modules were distributed.
Reason: A short allowed by an alarm lamp design may disable
conductivity or temperature monitoring, alarm, and/or
bypass circuit.
----
Product: Candela LaserTripter System (a) Model MDL-1;
(b) Model MDL-2000, used for urinary/biliary laser
lithotripsy. Recall #Z-015/016-1.
Code: MDL-1 (modified) serial numbers 0001 through 0151,
non-inclusive; MDL-1 (modified) serial numbers 1152
through 1179, inclusive; MDL-2000 serial numbers 1180
through 1238, inclusive.
Manufacturer: Candela Laser Corporation, Wayland, Massachusetts.
Recalled by: Manufacturer, by letter May 14, 1990. Firm-initiated
recall ongoing.
-8-
Distribution: Nationwide and international.
Quantity: l85 finished devices are subject to recall.
Reason: The 320 micron fiber may break, causing fragments
to remain in the body.
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Product: Cobe Spectra Apheresis System Centrifuge Collar Holder,
a component of the Spectra Apheresis Machine designed to
hold blood tubing sets in a configuration during
centrifugation. Recall #Z-017-1.
Code: Catalog Nos. 950000-000 through 950000-003, and
950000-005. Serial numbers 1S00028 through 1S00192.
Manufacturer: Cobe Laboratories, Inc., Lakewood, Colorado.
Recalled by: Manufacturer, by letter on or about September 24, 1990.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 415 units remain on the market.
Reason: The centrifuge collar holder may not stay closed
during a procedure, due to wear of components. The
centrifuge collar can come out of the holder, cause the
tubing to break, and create a saline or blood leak during
a procedure.
----
Product: CeraMed brand Osteograf/P Periodontal Hydroxylapatite,
0.5g Prefilled Syringes, a sterile high purity, high
density, nonresorbable, radiopaque, permanent particulate
implant (bone grafting) material used for repair of
periodontal lesions, packaged 8 syringes per carton.
Recall #Z-018-1.
Code: Lot #9219262.
Manufacturer: CeraMed Corporation, Lakewood, Colorado.
Recalled by: Manufacturer, by letter January 31, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Egypt, Canada.
Quantity: 144 syringes were distributed; firm estimates none
remains on market.
Reason: The sterility of the product may be compromised
because of faulty pouch seals.
----
Product: Cordis II Super Torque Angled Pigtail Ventricular
Catheter. Recall #Z-021-1.
Code: Catalog #532-533A, lot #R-689501.
Manufacturer: Cordis Europa N.V., The Netherlands.
Recalled by: Cordis Corporation, Miami Lakes, Florida, by telephone
May 3, 1990. Firm-initiated recall complete.
Distribution: Nationwide, Hong Kong.
-9-
Quantity: 775 units were distributed.
Reason: The sterility of the product may be compromised
due to open package end seals.
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Class III -
Product: Companion 2801 Portable Volume Ventilator a device
which provides support for ventilator-dependent patients in
both the hospital and home care settings. Recall #Z-741-0.
Code: Serial numbers 000040PI through 000057PI,
000101DE through 000297DE.
Manufacturer: Puritan-Bennett, Portable Ventilator Division,
Boulder, Colorado.
Recalled by: Manufacturer, by letter August 2, 1990. Firm-initiated
recall ongoing.
Distribution: Nationwide, Canada, Italy, England.
Quantity: 210 units were distributed.
Reason: The transient electrical fluctuation of short duration
may cause the fuse in the Companion 2801 Portable Volume
Ventilator to blow unnecessarily. Should this occur, the
ventilator will switch to battery operation with the
normal alarm to signal the fact.
----
Product: Lifescan Hospital One Touch Test Strips for Blood
Glucose Meter, an in-vitro diagnostic device.
Recall #Z-760-0.
Code: Lot #910464A EXP 6/91.
Manufacturer: Lifescan, Inc., Mountain View, California.
Recalled by: Lifescan, Inc., Milpitas, California, by telephone
April 3-4, 1990. Firm-initiated recall ongoing.
Distribution: Nationwide, Canada.
Quantity: 176 boxes were distributed.
Reason: The High Control Range for product testing was printed
as 272-280 mg/dL instead of the correct range 272-380
mg/dL.
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VETERINARY PRODUCTS
NONE
-10-
Seizure Actions Filed:
Product: GSL Cellular Products (90-581-561).
Charge: Unapproved new drugs and the articles' labeling fails to
bear adequate directions for use.
Firm: TransAmerica Mailings, Inc., Berea, Ohio.
Filed: September 28, 1990 - U.S. District Court for the
Northern district of Ohio, Eastern Division;
Civil #1:90CV1737, FDC #65889.