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
03/02/1994
Recalls and Field Corrections: Foods -- Class I -- 03/02/1994
March 2, 1994 94-9 -- Recalls and Field Corrections: Foods --
Class I
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Gift boxes labeled (a) 8 Nights of Hanukkah (4 ounce boxes
of nuts); (b) 12 Days of Christmas (6 ounce toxes of mixed
nuts). Recall #F-299/300-4.
CODE All product shipped prior to and including 12/14/93.
MANUFACTURER Harry & David Corporation, Medford, Oregon.
RECALLED BY Manufacturer, by mailgram December 15, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 3,018 boxes; (b) 8,433 boxes were distributed.
REASON Products contained peanuts which are not declared on the
label.
_______________
PRODUCT Satay's Original All Natural Spicy Peanut Sauce in various
size bottles. Recall #F-309-4.
CODE All lots.
MANUFACTURER Texas Food Research, Inc., Austin, Texas.
RECALLED BY Manufacturer, by telephone on or about January 6, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 761 cases (4 units 8-ounce jars) 8 cases (6 units 1.5-ounce
jars); 15 cases 7 units 16-ounce jars (12 jars per case)
were distributed.
REASON Product has the potential to support the outgrowth of
Clostridium botulinum toxin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Mocha Mix Lite Non-Dairy Creamer, liquid, 1 quart size.
Recall #F-298-4.
CODE Lot #A2523 47-126 10/21/93.
MANUFACTURER Presto Food Products, Inc., Arlington, Tennessee.
RECALLED BY Presto Food Products, Inc., City of Industry, California, by
verbally notifying sales representatives on October 15,
1993. Firm-initiated recall complete.
DISTRIBUTION Tennessee, Illinois, Minnesota, Missouri, Texas.
QUANTITY 766 cases (12 units per case) were distributed.
REASON Product was contaminated with sanitizer.
_______________
PRODUCT Various Cheeses: (a) Monterey Jack Cheese; (b) Brick
Cheese; (c) Pizza Shredded Cheese; (d) Taco Nacho Shredded
Cheese Blend. Recall #F-305/308-4.
CODE (a) Crystal Farms Monterey Jack Cheese, Net Wt. 8 ounces,
sell by 5-23-94;
Crystal Farms Monterey Jack Cheese in random weight
packages of about 15 ounces each, sell by 5-20-94 and
5-29-94;
Crystal Farms Monterey Jack Cheese in random weight
packages of about 24 ounces each, sell by 5-20-94 and
6-04-94;
Crystal Farms Monterey Jack Cheese in random weight
packages of about 35 ounces each, sell by 5-20-94;
Crystal Farms Monterey Jack Cheese, Net Wt. 5 pounds,
sell by 5-23-94;
(b) Crystal Farms Brick Cheese in random weight packages of
about 15 ounces each, sell by 5-20-94 and 5-29-94;
(c) Crystal Farms Pizza Shredded Cheese Blend, Net Wt. 16
Ounces, sell by 4-29-94 and 5-06-94
(d) Crystal Farms Taco Nacho Shredded Cheese Blend, Net Wt.
8 ounces, sell by 5-30-94 and 6-04-94.
MANUFACTURER Associated Milk Producers, Inc., Rochester, Minnesota.
RECALLED BY Crystal Farms, Inc., Minneapolis, Minnesota, by telephone
January 7, 1994. Firm-initiated recall complete.
DISTRIBUTION Colorado, Minnesota, Missouri, Nebraska, Ohio, Pennsylvania,
Wisconsin.
QUANTITY 4,239 cases were distributed; firm estimates none remains on
the market.
REASON Products were contaminated with pieces of metal.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Geneva brand Ferrous Gluconate 5 grains, 100 tablet bottles,
nonprescription dietary supplement. Recall #F-301-4.
-2- CODE Lot numbers: 111051A EXP 11/93, 203032B EXP 5/94, 208116A
EXP 9/94.
MANUFACTURER Able Laboratories, Inc., S. Plainfield, New Jersey.
RECALLED BY Manufacturer, by letter dated September 13, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 86,770 bottles were distributed.
REASON Product fails dissolution test.
_______________
PRODUCT "ONDO" "OPC" brand High Potency Multi-Vitamin & Mineral
Tablets with Beta-Carotene, in bottles of 30.
Recall #F-302-4.
CODE Lot #29654 EXP 7/96.
MANUFACTURER International Vitamin Corporation, Irvington, New Jersey.
RECALLED BY Manufacturer, by telephone September 15, 1993. Firm-
initiated recall complete.
DISTRIBUTION Illinois, California.
QUANTITY 14,760 bottles were distributed.
REASON Labeling error, label read Vitamin C (acetate and Beta-
Carotene) when it should have read Vitamin A (acetate and
Beta-Carotene).
_______________
PRODUCT Celebrity Fancy Whole Segments Mandarin Oranges in Light
Syrup, in 11 ounce cans. Recall #F-304-4.
CODE All codes.
MANUFACTURER Product of the Peoples Republic of China.
RECALLED BY Atalanta Corporation, Elizabeth, New Jersey, by letters
dated October 21, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 101,000 cases (24 cans per case) were distributed.
REASON Product is contained in detinning cans.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Synarel (nafarelin acetate) Nasal Solution 2 mg/ml (as
nafarelin base), Rx for the treatment of endometriosis and
central precocious puberty (CPP). Recall #D-133-4.
CODE Lot #05949D.
MANUFACTURER Syntex Laboratories, Inc., Palo Alto, California.
RECALLED BY Manufacturer, by letter January 18, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Belgium.
QUANTITY 7,224 bottles were distributed.
REASON Bottle label does not provide complete dosage information.
_______________
PRODUCT Various Rx drugs packaged by Allscrips Pharmaceuticals
Inc., Vernon Hills, Illinois:
Hydroxyzine Hydrochloride Tablets, for symptomatic relief of
anxiety and tension associated with psychoneurosis:
-3- (a) 10 mg, packaged in bottles of 30, 100, 50, 20, 10 and 15
tablets;
(b) 25 mg, packaged in bottles of 20, 30, 100, 21, 60, 10,
15, 12, 6, 40 and 30 tablets;
(c) 50 mg, packaged in bottles of 100 and 30 tablets;
(d) 25 mg; packaged in bottles of 50, 12, 20, 6, 100 and 30
capsules;
Hydroxyzine Pamoate Capsules, for symptomatic relief of
anxiety and tension associated with psychoneurosis:
(e) 50 mg, packaged in bottles of 12, 20, 100 and 50
capsules;
(f) Indomethazine Capsules, 50 mg, packaged in bottles of
21, 30, 100, 15, 60, 20 and 24 capsules, for the treatment
of the active stages of moderate to severe rheumatoid
arthritis and osteoarthritis;
(g) Methylprednisolone Tablets, 4 mg, packaged in bottles of
30 and 60 tablets, a glucocorticoid anti-inflammatory;
(h) Phenylbutazone Tablets, 100 mg, packaged in bottles of
15, 30 and 21 tablets, an anti-inflammatory for the
treatment of acute gouty arthritis, active rheumatoid
arthritis and active ankylosing spondylitis;
(i) Spironolactone Tablets, 25 mg, packaged in bottles of
100, 30, and 250 tablets; a diuretic and antihypertensive;
(j) Sulfamethoxazole & Trimethoprim Tablets, 800/160 mg,
packaged in bottles of 10, 14, 20 and 28 tablets, a
synthetic antibacterial combination product used for the
treatment of urinary tract infections and other infections
due to susceptible strains of organisms.
Recall #D-136/145-4.
CODE All unexpired lots.
MANUFACTURER Chelsea Laboratories Caribe, Inc., Bayamon, Puerto Rico
(products a-e); Chelsea Laboratories, Inc., Monroe, North
Carolina (products f-j).
RECALLED BY Allscrips Pharmaceuticals Inc., Vernon Hills, Illinois
(repacker), by letters dated January 5, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,120 bottles of 30, 145 bottles of 100, 64 bottles of
50, 475 bottles of 20, 47 bottles of 10, 247 bottles of 15
were distributed.
(b) 8,893 bottles of 20, 20,263 bottles of 30, 84 bottles of
100, 152 bottles of 21, 30 bottles of 60, 450 bottles of 10,
1,147 bottles of 15, 390 bottles of 12, 452 bottles of 6 and
6 bottles of 40 were distributed.
(c) 41 bottles of 100 and 201 bottles of 30 were
distributed.
(d) 42 bottles of 50, 30 bottles of 12, 145 bottles of 20,
1 bottle of 6, 18 bottles of 100 and 61 bottles of 30 were
distributed.
(e) 15 bottles of 12, 100 bottles of 20, 35 bottles of 100
and 32 bottles of 50 were distributed.
-4- (f) 194 bottles of 21, 693 bottles of 30, 35 bottles of 100,
137 bottles of 15, 15 bottles of 60, 32 bottles of 20 and 83
bottles of 24 were distributed.
(g) 23 bottles of 30 and 5 bottles of 60 were distributed.
(h) 118 bottles of 15, 252 bottles of 30 and 979 bottles of
21 were distributed.
(i) 96 bottles of 100, 271 bottles of 30 and 8 bottles of
250 were distributed.
(j) 850 bottles of 10, 710 bottles of 14, 2,469 bottles of
20 and 150 bottles of 28 were distributed. Firm estimates
that about 25% of the products remain on the market.
REASON Abbreviated New Drug Approval discrepancies.
_______________
PRODUCT Sulfasalazine Tablets, USP 500 mg, indicated for the
treatment of mild to moderate ulcerative colitis, in bottles
of 500 under Lederle, Schein, and Goldline labels.
Recall #D-146-4.
CODE All lots.
MANUFACTURER Lederle Laboratories Pearl River, New York.
RECALLED BY Manufacturer, by letter January 21, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Jorda, Quatar, United Arab Emirates.
QUANTITY Approximately 250,000 bottles were distributed.
REASON Product does not meet dissolution specifications.
_______________
PRODUCT Medical Oxygen USP, in size E and K cylinders.
Recall #D-147-4.
CODE Lot numbers 14-18 manufactured February 2-14, 1994.
MANUFACTURER Acetylene Oxygen Company (AOC), Rosenberg, Texas.
RECALLED BY Manufacturer, by visit February 18, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Texas.
QUANTITY 33 cylinders were distributed.
REASON Current good manufacturing practice discrepancies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Mylanta Double Strength, liquid antacid, in 1 ounce units,
for hospital use. Recall #D-135-4.
CODE Lot numbers: JFP335 EXP 5/94, JSP706 EXP 11/94.
MANUFACTURER Johnson & Johnson Merck Consumer Products Company, Pasadena,
California.
RECALLED BY Johnson & Johnson Merck Consumer Pharmaceutical Company,
Fort Washington, Pennsylvania, by letter dated February 2,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates that little of the product remains at the
hospital level.
REASON Subpotency of simethicone ingredient.
-5- _______________
PRODUCT Genaton, in 12 fluid ounce bottles, an OTC liquid antacid.
Recall #D-148-4.
CODE Lot numbers: 13-2P004, 13-2P005, 13-2P006 EXP 12/94.
MANUFACTURER KC Pharmaceuticals, Inc., Pomona, California.
RECALLED BY Manufacturer, by letter July 8, 1993. Firm-initiated recall
complete.
DISTRIBUTION California, Ohio.
QUANTITY Approximately 26,000 bottles were distributed.
REASON Label incorrectly declares "Each teaspoonful (15 ml)
contains ..." instead of "Each tablespoonful (15 ml)
contains ..."
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Infusion Sets: (a) Angio-Set; (b) Intima brand Infusion
Sets, sterile I.V. catheter/needle units.
Recall #Z-733/734-3.
CODE Catalog numbers: (a) 3861181, 3861201, 3861221, 3862201,
3862221, 3864161, 3864181, 3864201, 3864221; (b) 3863181,
3863201, 3863221, 3863241, 3867201, 3867221, 3867241,
3869181, 3869201, 3869221, 3869241.
MANUFACTURER Micropette, Inc., Division of Becton Dickinson Company,
Juncos, Puerto Rico.
RECALLED BY Becton Dickinson Vascular Access, Sandy, Utah, April 1,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Australia, Belgium, Singapore, Brazil,
Japan.
QUANTITY 1.4 million units were distributed.
REASON The stylet hub glued to the intermittent infusion diaphragm
could cause a needle stick injury to the patient or
healthcare professional.
_______________
PRODUCT Volume Ventilator Breathing Circuits:
(a) Custom Configuration Pediatric, Product Code 156355;
(b) Adult Heated Wire, Product Code 157627;
(c) Adult Heated Wire, Product Code 1576380;
(d) Bear 1 and 2 Adult Heated Wire, Product Code 1576689;
(e) Heated Wire for LP-6, PLV100, & 102, PB2800 & 2800, Bear
33, Product Code 1576712. Recall #Z-771/775-3.
CODE Lot numbers: (a) 67297;, 67298, 67298A; (b) 65683, 66701;
(c) 65758, 66909 66909A, 68220, 68430, 68589, 68634, 68893;
(d) 65490, 68635, 68894; (e) 66734, 66735, 66736, 66737.
MANUFACTURER Marquest Medical Products, Inc., Englewood, Colorado.
RECALLED BY Manufacturer, by letter July 14, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Puerto Rico.
QUANTITY Approximately 467 cases (10 units per case) were
distributed; firm estimates that 389 cases remain on the
market.
REASON The breathing circuits may contain exhalation valve caps
that have cracked and/or are loose.
-6-
_______________
PRODUCT National Medical Care Catheter Co-Pack:
(a) Catheter Adapter Co[Pack, Catalog #48-0122-7;
(b) DextroLyte II CAPD Training Kit, Catalog #48-0110-6;
(c) DextroLyte II CCPD Training Kit, Catalog #48-0120-5;
(d) DextroLyte II Bagless Training Kit, Catalog #48-0140-3.
Recall #Z-212/215-4.
CODE Lot numbers: (a) M3C511, M3CD505, M2S510, M3L503;
(b) M3D524; (c) M3C502, M3D525; (d) M3C501, M3D526.
MANUFACTURER National Medial Care, Medical Products Division, McAllen,
Texas.
RECALLED BY National Medical Care, Medical Products Division, Rockleigh,
New Jersey, by letter dated October 19, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,454 units were distributed.
REASON Incorrect assembly of the threaded portion of the patient
catheter adapter could confuse home patients who need to
adapt their treatment.
_______________
PRODUCT Fortress "Scooter" Line of Motorized Wheelchairs for adult
and pediatric use:
(a) Model 1700 FS; (b) Model 1704 FS; (c) Model 2000 FS,
Model 2000 PD, Model 2000 S (variations of the 2000FS); (d)
Model 2001 LX; (e) Model 2001 LXS; (f) Model 2500 FS.
Recall #Z-217/222-4.
CODE Serial numbers represent all units built between January 1,
1991 and August 18, 1993.
(b) 1001 - 1888; (b) 1043 - 1490; (c) 39793 - 46512;
(d) 2574 - 4585; (e) 101 - 227; (f) 586 - 649.
MANUFACTURER Fortress Scientific Ltd., Downsview, Ontario, Canada.
RECALLED BY Fortress Scientific Ltd., Buffalo, New York, by letters
dated October 22, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,380 units were distributed.
REASON The scooters contain potentiometers which may malfunction
and cause unintentional movement.
_______________
PRODUCT Sensormedics Model 3100A high frequency oscillatory
ventilator, intended for normal and emergency treatment of
respiratory failure and barotrauma in neonates.
Recall #Z-224-4.
CODE All units within the serial number range 31449 through
31508.
MANUFACTURER Sensormedics Corporation, Yorba Linda, California.
RECALLED BY Manufacturer, by letter September 7, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Alaska, Arizona, Colorado, Florida, Georgia, Hawaii,
Illinois, Louisiana, Massachusetts, Michigan, Minnesota,
Missouri, New Mexico, Nevada, Texas, Virginia, Wisconsin,
Canada, Mexico, The Netherlands, Austria, Germany, Italy,
-7- Switzerland, The United Kingdom.
QUANTITY 60 units were distributed.
REASON The product has incorrectly soldered electronic components
causing the piston centering voltage to float resulting in
the delivery piston periodically exceeding its normal range
of operation, I.e., drifts from center. This could cause a
failure to deliver positive pressure ventilation.
_______________
PRODUCT Three Wheel Scooters, motorized, self-operated wheel chairs
for disabled persons:
(a) Lark Front Wheel Drive Scooters, Models 4302, 4303,
4304
(b) Lark Rear Wheel Drive Scooters, Models 4350 & 4351
(c) Lark XT Scooters, Models 4370 & 4371
(d) TraveLark Front Wheel Drive Scooters, Model 4371
(e) Park Lark, Models 4355 & 4356
(f) Pony, Junior, Model 4310
(g) Pony, Senior, Model 4311
(h) Pony II, Junior, Model 4312
(i) Pony II, Senior, Model 4313
(j) Dart, Model 4320 & 4330
(k) Spirit, Model 433
(l) Bravo, Model 434
(m) Sierra Front Wheel Drive, Model 440 & 441
(n) Sierra Rear Wheel Drive, Model 445 & 446
(o) Colt, Front Wheel Drive, Model 4360
(p) Colt, Rear Wheel Drive, Model 4365
(q) Encore, Model 4380
(r) Triumph, Model 4390
(s) E-Z Shopper/Lark E-Z Shopper, Model 4700
(t) Mini-Shopper/Mall Lark, 4710. Recall #Z-227/246-4.
CODE Scooters manufactured from April 1983 through October 1991.
Serial numbers are below 85430.
MANUFACTURER Ortho-Kinetics, Inc., Waukesha, Wisconsin.
RECALLED BY Manufacturer, by letters sent September 24, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 64,000 units were distributed.
REASON The scooter seats may break away from the scooter.
________________
PRODUCT Podiatry X-Ray Systems, mobile and wall mounted, used in
podiatric studies: (a) Model PW200; (b) Model PW300; (c)
Model PM200; (d) Model PM300. Recall #Z-248/251-4.
CODE Model numbers: PW200, PW300, PM200, PM300 podiatric systems
containing the R-120 series collimators.
MANUFACTURER Mikasa X-ray Company, Ltd., Tokyo, Japan.
RECALLED BY MinXray, Inc., Northbrook, Illinois. FDA approved the
firm's corrective action plan February 16, 1994. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide.
-8- QUANTITY More than 200 units.
REASON Units failed to met light illuminance requirement at a
source to image distance (SID) of 40 inches and failed to
meet edge contrast ratio requirement at an SID of 40 inches.
_______________
PRODUCT Accu-Sorb Sterile Laparotomy Sponges, single use, x-ray
detectable:
(a) 4" X 18" Lap Sponges, Part Numbers: MDS 22-1104, MDS
22-1104NL, MDS 23-1104, MDS 23-1104R, MDS 23-1304, MDS
23-1504, MDS 23-2104, MDS 24-1504;
(b) 8" X 36" Lap Sponges, Part Numbers: MDS 22-1136R, MDS
23-1136, MDS 23-1136R, MDS 23-1336, MDS 23-1536, MDS
24-1536;
(c) 8" X 108" Lap Sponges, Part Number: MDS 22-11108;
(d) 12" X 12" Lap Sponges, Part Numbers: MDS 22-1112, MDS
23-1112, MDS 23-1112R, MDS 23-1312, MDS 23-1512, MDS
23-2112, MDS 24-1512, MDS 24-1512R, MDS 23-4612;
(e) 18" X 18" Lap Sponges, Part Numbers: MDS 22-1118, MDS
23-1118, MDS 23-1118R, MDS 23-1118NL, MDS 23-1318, MDS
23-1318NL, MDS 23-1518, MDS 23-1518R, MDS 23-1518NL, MDS
23-2118, MDS 24-1518, MDS 24-1518R. Recall #Z-308/312-4.
CODE All lots.
MANUFACTURER Medline Industries, Inc., Mundelein, Illinois.
RECALLED BY Manufacturer, by letters dated January 18, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 133,900 cases were distributed; firm estimates
30 percent of the product remains on the market.
REASON The lap sponges may be nonsterile due to possible
contamination with mold and/or bacteria.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Baxter "Smart Label", Catalog #6461610, designed for
attachment to the Bard Infuso.R Pump. Microprocessors in
the pump decodes magnetic sensors in the card, which called
a "smart label", to determine the delivery rate of the drug.
Recall #Z-730-3.
CODE Catalog #6461610, lot #77322 (on white envelope); also known
as Assembly Order number on Smart Label - Reorder #6461610,
lot 30305001, Rev. 0.
MANUFACTURER Labels, Inc., Amesbury, Massachusetts.
RECALLED BY Baxter Healthcare Corporation, N. Reading, Massachusetts, by
telephone followed by letter April 15, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 86 labels were distributed.
REASON The Smart Label illustrations contain an error which may
result in incorrect volume infusion of a drug.
-9- _______________
PRODUCT Volumetric Infusion Pump, IVAC Model 599, used for the
delivery of drugs. Recall #Z-804-3.
CODE All lot numbers.
MANUFACTURER IVAC Corporation, Creedmor, North Carolina.
RECALLED BY IVAC Corporation, San Diego, California, by letter June 8,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,359,631 sets were distributed; firm estimates none remains
on the market.
REASON Design defect. The lower segment does not always seat fully
into the air-in-line assembly causing a delay in the loading
of the set and administering the medication.
_______________
PRODUCT HCL Bi-Layer Blood Agar, 4% Horse Blood, Prepared Culture
Media Plates, for in-vitro diagnostic use to differentiate
hemolytic bacteria from non-hemolytic bacteria, Product
#S1170. Recall #Z-255-4.
CODE Lot #2343 EXP 11/9/93.
MANUFACTURER Micro Diagnostics, Inc., Lombard, Illinois.
RECALLED BY Manufacturer, by telephone December 15, 1993. Firm-
initiated recall complete.
DISTRIBUTION Iowa, Maryland.
QUANTITY 40 plates were distributed.
REASON The media started to hemolyze the plates prior to their
expiration date.
_______________
PRODUCT SafeCrit-Heparinized Micro-hct Tubes, used to measure packed
red cell volume via capillary (fingerstick) blood sampling
by the microhematocrit method:
(a) Safe-Crit-heparinized micro-hematocrit tube, 75 mm
length, Catalog #HP4H;
(b) Safe-Crit-heparinized microhematocrit tube, 40 mm
length, Catalog #HP8H. Recall #Z-256/257-4.
CODE Lot numbers: (a) 3278, 3216, 3111, 3034, 2350, 2300, 2126,
1298; (b) 3281, 3280, 3167, 3109, 2351, 2338, 2295, 2224,
2059.
MANUFACTURER KABE Labortechnik GmbH, Nuembrecht, Elsentotz, Germany.
RECALLED BY StatSpin Technologies, Norwood, Massachusetts, by letters
November 11 and 29, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, England, Portugal, Thailand, Japan, Canada.
QUANTITY 2,428,600 units were distributed.
REASON Product results in falsely high hematocrit readings
associated with variation in the heparin anticoagulant
coating.
_______________
PRODUCT Coulter Dacos Glucose Reagent, in 24 ml vials, for the
quantitative determination of glucose. Recall #Z-313-4.
CODE Coulter Part #2907085 (box), lot #15800 EXP 5/95.
-10- MANUFACTURER Trace America, Inc., Australia.
RECALLED BY Coulter Corporation, Miami, Florida, by letter dated October
5, 1993. Firm-initiated field correction ongoing.
DISTRIBUTION Florida, Georgia, Illinois, Indiana, Kansas, Michigan, New
York, Ohio, Pennsylvania, Texas, Turkey, United Kingdom,
Canada.
QUANTITY Undetermined.
REASON The reagent bottle states that the reagent should be
reconstituted with 24 ml of diluent and the package insert
states 20 ml. The 24 ml is correct.
_______________
PRODUCT Coulter 5C Abnormal II Cell Control, a vial of liquid
control material, designed to represent defined abnormal
human blood, and intended for use in specific Coulter
instruments/systems which are named in the labeling.
Recall #Z-314-4.
CODE Lot numbers: 860400, 860500, 860600.
MANUFACTURER Coulter Corporation, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter beginning May
20, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada.
QUANTITY Firm estimates none remains on the market.
REASON The white blood cell parameters sometimes exceed the labeled
range.
_______________
PRODUCT Dacos Cuvettes, for use with the Dacos Chemistry Analyzer
for in-vitro diagnostic use, Part #1016508.
Recall #Z-315-4.
CODE All lot numbers below 190102, Catalog #6603624.
MANUFACTURER Tech Plastics, Tempe, Arizona.
RECALLED BY Coulter Corporation, Miami, Florida, by letters beginning
February 25, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates none remains on the market.
REASON Undersized cuvettes are pulled out of the wheel by the wash
station causing the wheel to jam and the analyzer to stop.
_______________
PRODUCT Coulter Isovial White and Red Capillary Pipets:
(a) Part #7546971 Coulter Isovial White, intended for
counting leukocytes and measuring hemoglobin; (b) Part
#7546970 Red Capillary Pipets, intended for counting and
sizing erythrocytes. Recall #Z-316/317-4.
CODE Lot numbers: (a) 107978K, 107979K1, 107979K2, 107980K,
107981K1, 107981K2, 107982K, 107983K1, 107983K2, 107984K1,
107984K2, 107985K, 107986K, 107987K1, 107987K2, 107988K,
107989K, 107990K, 107991K1, 107991K2, 107992K, 107993K,
107994K, 107995K1, 107996K1, 107996K2, 107999K;
(b) 108055K, 108056K, 108057K, 108058K, 108059K, 108060K,
108061K, 108062K, 108063K, 108064K, 108065K, 108065K1,
108066K 108067K, 108068K.
-11- MANUFACTURER Coulter Corporation, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letters dated July
28, 1992, September 16 and 28, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 41 lots of Isovial Red and White (approximately 142,000
individual units of sale) covered on recall letter dated
7/28/92. Recall of Isovial White lot 107999K involved 4,920
individual units. An individual unit of sale consists of 1
package of 30 vials.
REASON Pipets may leak.
_______________
PRODUCT Coulter 5C Cell Controls, 3.3ml, for in-vitro diagnostic
use: (a) Normal; (b) Abnormal I; (c) Abnormal II.
Recall #Z-318/320-4.
CODE Lot numbers: (a) 882300, 882400, 882500, 882600, 882700;
(b) 872300, 872400, 872500, 872600;
(c) 862300, 862400, 862500, 862600.
MANUFACTURER Coulter Corporation, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter beginning
February 15, 1993. Firm-initiated recall complete.
DISTRIBUTION nationwide and international.
QUANTITY Firm estimates none remains on the market.
REASON Reported low eosinophil percent and numbers.
_______________
PRODUCT Dacos and Dacos 2 Chemistry Software, with revisions 1.74,
1.75, and 1.76. Recall #Z-321/328-4.
CODE Catalog numbers: 6602008, 6602278, 6602842, 6602843,
6603321, 6603322, 6603323, 6603324.
MANUFACTURER Coulter Corporation, Hialeah, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter beginning
June 4, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION South Carolina, California, Australia, Canada, France,
Germany, United Kingdom, Japan, Hong Kong.
QUANTITY Undetermined.
REASON While programming samples, if the cursor is moved into the
year section of the field, the year 1992 and all subsequent
years cannot be entered in the appropriate field.
_______________
PRODUCT Coulter Epic DNA Software, Version 2.1, designed for use on
the customer's own computers, i.e., not internally in
Coulter's line of flow cytometers, some of which are
computer-equipped. Recall #Z-329/340-4.
CODE (a) Part No. 6603581, Pkg, Cytologic Swre Multi User Combo;
(b) Part No. 6603582, Pkg, Cytologic Swre Single User Combo;
(c) Part No. 6603915, Pkg, Swre, Library, DNA;
(d) Part No. 6603916, Pkg, Swre, Library, Immuno;
(e) Part No. 6603917, Pkg, Swre, Library, Immuno, Plural;
(f) Part No. 6603918, Pkg, Swre, DNA, Plural;
-12- (g) Part No. 6912692, Mod Kit, Swre Library, Immuno;
(h) Part No. 6912694, Mod Kit, Swre Library, (Plural);
(i) Part No. 6912695, Mod Kit, Swre Library, DNA Plural;
(j) Part No. 6912696, Mod Kit, Swre Library, DNA;
(k) Part No. 6912699, Mod Kit, Swre Library, DNA, Immuno;
(l) Part No. 6912700, Mod Kit, Swre Library, DNA/Immuno
(Plural).
MANUFACTURER Coulter Corporation, Miami Lakes, Florida.
RECALLED BY Coulter Corporation, Miami, Florida, by letter beginning
October 15, 1991. Firm-initiated field correction complete.
DISTRIBUTION Maryland, Louisiana, Texas, Kentucky, Arkansas, Illinois,
Massachusetts, Wisconsin, Washington, D.C., New Jersey,
Connecticut, Minnesota, North Carolina, Missouri, Virginia,
Michigan, Georgia, Florida, Belgium, Canada, The United
Kingdom, France, Germany, India, Italy, The Netherlands,
Norway, South Africa, Spain.
QUANTITY Firm estimates none remains on the market.
REASON Some of the computer disks which were labeled as version 2.1
were in fact, version 2.01.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Radix Labs Milk Fever 23% Sterile non-pyrogenic
(Injectable), in 500 ml bottles nutritional supplement for
bovine. Recall #V-032-4.
CODE Lot #R4A001.
MANUFACTURER Laboratories, Inc., Eau Claire, Wisconsin.
RECALLED BY Manufacturer, by telephone January 25, 1994. Firm-initiated
recall complete.
DISTRIBUTION Iowa, New York, Wisconsin.
QUANTITY 912 bottles were distributed.
REASON Precipitate matter formed in the product caused by use of an
unstable ingredient in the production.
MEDICAL DEVICE SAFETY ALERTS
==============================================
_______________
PRODUCT Ace Aerosol Cloud Enhancer, Rx device designed to assist
with the delivery of aerosolized medications from metered
dose inhalers (MDI):
(a) Reorder #DHD 11-1010, Ace MDI Spacer;
(b) Reorder #DHD 11-1020, Ace MDI Spacer Kit (contains 1 Ace
and 1 Adapter Kit);
(c) Reorder #DHD 11-2020 (same as DHD 11-1020 except for
immediate product packaging). Safety Alert #N-036/038-4.
CODE Reorder numbers Lot numbers
DHD 11-1010 135480, 191269
DHD 11-1020 135475, 189434
DHD 11-2020 209721.
MANUFACTURER DHD - Diemolding Healthcare Division, Wampsville, New York.
ALERTED BY DHD - Diemolding Healthcare Division, Canastota, New York,
by letter December 29, 1993.
-13- DISTRIBUTION Nationwide and Canada.
QUANTITY (a) 29,615; (b) 175,400; (c) 2,245 units were distributed.
REASON After prolonged use the ACE MDI spray dispenser could crack.
This can cause the whole dispenser to drop into the body of
the ACE when the MDI canister is actuated.
_______________
PRODUCT All Purpose Chair (APC), a chair which converts to a
reclining position, used in hospitals for patient treatment
and for patient transport operations.
Safety Alert #N-039-4.
CODE Model Numbers Serial Numbers
APC000 1 through 1203
APC200 1 through 1789
APC300 1 through 23
APC400 1 through 110
APCFLR 6 through 31
APCEYE 1 through 21
VIC 1 through 70.
MANUFACTURER Hausted, Inc., Medina, Ohio.
ALERTED BY Manufacturer, by Custom Bulletin distributed on or around
May 1, 1990.
DISTRIBUTION Nationwide.
QUANTITY 3,241 chairs were distributed.
REASON Chairs may tip or flip over. The firm emphasized their
warning already on the All Purpose Chair by use of statement
"Do Not Sit on End - Tipping May Occur" in a customer
Bulletin distributed to all consignees.
CRIMINAL INFORMATION:
=====================================================
DEFENDANT Jesus A. Rodriguez, doing business as Farmacia de Watto,
Canovanas, Puerto Rico.
CHARGE In a one-count Information, the Defendant plead guilty to
knowingly selling and offering to sell Triphasil-28, a
prescription drug that was clearly labeled "Sample-Not for
Sale," on or about January 17, 1991. Sentencing has been
scheduled for May 17, 1994.
FILED February 4, 1994; U.S. District Court for the District of
Puerto Rico; Cr. #94-40(RLA); FDC #66548.
SEIZURES:
=================================================================
_______________
PRODUCT Canned mushrooms (93-594-119 and 93-593-934).
CHARGES Adulterated - A sample from one of the same can codes as
present in this lot contains an added poisonous and
deleterious substance, staphylococcal enterotoxin, which may
render it injurious to health and the articles were prepared
and packed under conditions whereby they may have been
rendered injurious to health. Misbranded - All of the
-14- articles' labeling is false and misleading because it
represents and suggests that the articles were grown and
packed in Taiwan, which is contrary to fact.
LOCATIONS Smith's Terminal Distribution Systems, and Hammersmith,
Inc., Miami, Florida.
FILED January 11 and 27, 1994; U.S. District Court for the
Southern District of Florida; Civ. ##94-166-CIV-HIGHSMITH
and 94-165-CIV-HOEVLER; FDC ##66792, 66794.
SEIZED February 1, 1994 - goods valued at approximately $29,760 and
$16,900.
_______________
PRODUCT Cyan-5 Five Way Wormer (93-505-983/4).
CHARGES New animal drug - The article is unsafe because no approved
application is in effect with respect to its intended use.
Misbranded - The article's labeling bears no accurate
statement of the quantity of its contents and no caution
statement for veterinary prescription drugs; and, the
article is offered for sale to lay persons without the
benefit of a veterinarian/client relationship and the
labeling bears no adequate directions for its intended use.
LOCATION National Hog Medicine Company, d/b/a National Livestock
Supply Company, Raleigh, North Carolina.
FILED January 28, 1994; U.S. District Court for the Eastern
District of North Carolina, Raleigh Division; Civ.
#5:94-CV-46-F3; FDC #66800.
SEIZED February 16, 1994 - goods valued at approximately $5,827.
_______________
PRODUCT Frozen Pollock Fillets (94-710-328).
CHARGE Adulterated - The article consists in whole or in part of
decomposed seafood.
LOCATION Fulton Market Cold Storage Company, Chicago, Illinois.
FILED February 14, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civ. #94C 922;
FDC #66928.
SEIZED February 16, 1994 - goods valued at approximately $37,400.
-15-
END OF ENFORCEMENT REPORT FOR MARCH 2, 1994. BLANK PAGES MAY
FOLLOW.