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
05/04/1994
Recalls and Field Corrections: Foods -- Class II -- 05/04/1994
May 4, 1994 94-18
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Plantillas (Puertorican tortillas) in plastic bags.
Recall #F-389-4.
CODE None.
MANUFACTURER Marvel Specialties, Inc., Rio Piedras, Puerto Rico.
RECALLED BY Manufacturer, by visit beginning March 17, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY Undetermined.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Western Family brand Macaroni & Cheese, in 7.25 ounce
cardboard boxes. Recall #F-390-4.
CODE 12172KA and 12292KA.
MANUFACTURER Borden, Inc., doing business as Merlinos Macaroni, Kent,
Washington.
RECALLED BY Western Family Foods, Inc., Tigard, Oregon, by letter
February 11, 1993. Firm-initiated recall complete.
DISTRIBUTION To wholesale acounts in Washington state.
QUANTITY 1,620 cases (24 per case) of lot 12172KA ad 1,336 cases (24
per case) of lot 12292KA were distributed.
REASON Product may be contaminated with metal shavings.
_______________
PRODUCT Dial Hand and Body Lotion, also known as Dial Lotion, for
hotel and institutional use, in .25 fluid ounce packets,
0.75 fluid ounce jars, and in 55 gallon drums.
Recall #F-391-4.
CODE Bulk code is HB126. Final product codes are: F023M3H126
under the Pony Soldier label; F293J2126, F303J2126.
H283J32126 (Cross Country label); H283J2126, J063J2126,
J073J2126 (dial (AKA White Marble) label.
MANUFACTURER The Dial Corporation, Memphis, Tennessee (bulk manufacture).
RECALLED BY The Dial Corporation, Scottsdale, Arizona, by letters of
December 15 and 22, 1993 January 20, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 45 cases containing 288 0.75-oz jars of code F023M3HB126
were produced & sold.
Packet production & distribution, all in cases of 500 each:
F293J2126 (Cross Country label): 70 cases made & sold.
F303J2126 (Cross Country): 78 cases made & sold.
H283J2126 (Cross Country): 49 made; 48 sold; 1 held.
H283J2126 (Dial label AKA White Marble): 202 made; 195 sold;
7 held.
H303J2126 (Cross Country): 63 made & held; none distributed.
J053J2126 (Dial): 47 made & held; none distributed.
J063J2126 (Dial): 233 made; 113 distributed; 120 held.
J073J2126 (Dial): 127 made; 108 sold; 19 held.
J073J2126 (Cross Country): 101 made & held; none
distributed.
K163J2126 (Dial): 27 made & held; firm estimates 20% of the
product remain in commerce at the on-set of the recall.
REASON Product is contaminated with Pseudomonas ("Burkholderia")
cepacia.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT All Juice brand Apple Juice, in 64 ounce glass bottles.
Recall #F-387-4.
CODE NCH 07303B, NCH 08093A, NCH 08113B, NCH 09093A/B.
MANUFACTURER Natures Choice of North Carolina, Henderson, North Carolina.
RECALLED BY All Juice Food and Beverage Corporation, Ormond Beach,
Florida, by telephone followed by visit on or about January
19, 1994. Firm-initiated recall complete.
DISTRIBUTION Grocery wholesale accounts in Alabama, Florida, Georgia,
North Carolina, South Carolina, Virginia.
QUANTITY Undetermined.
REASON Product lacks the labeled ingredient Malic Acid.
-2- RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Symmetrel (amantidine HCl) 100 mg Capsules, in bottles of
100 Capsules, indicated for the prophylaxis and treatment of
signs and symptoms of infection caused by various strains of
influenza virus. It is also indicated int he treatment of
parkinsonism and drug-induced extrapyramidal reactions.
Recall #D-263-4.
CODE Lot #EEB021A EXP 1/95, EEB021B 1/95.
MANUFACTURER Dupont Merck Pharma, Manati, Puerto Rico.
RECALLED BY Dupont Merck Pharmaceutical Company, Wilmington, Delaware,
by letter April 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Bahrain.
QUANTITY 39,072 units were distributed; firm estimates non remains on
the market.
REASON Marginal subpotency.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Leukocytes
Removed; (c) Platelets; (d) Fresh Frozen Plasma; (e)
Cryoprecipitated AHF. Recall #B-213/217-4.
CODE Unit numbers: (a) 1784113, 2886566; (b) 4171411, 5645218;
(c) 1352402, 2886566; (d) 4171411; (e) 1784113.
MANUFACTURER Bloodcare, Dallas, Texas.
RECALLED BY Manufacturer, by letters of September 14 and 22, 1993, and
January 11-12, 1994. Firm-initiated recall complete.
DISTRIBUTION Texas, New Jersey, Florida.
QUANTITY (a) 2 units; (b) 2 units; (c) 2 units; (d) 1 unit; (e) 1
unit.
REASON Blood products collected from a donor who reported a history
of cancer, were distributed for transfusion.
_______________
PRODUCT Investigational products:
(a) Antilymphoblast Globulin (Equine);
(b) Cytomegalovirus Immune Globulin (Human);
(c) Thymocyte Immune Globulin (Equine)
(d) Antilymphoblst Globulin (Goat)
(e) Allergenic Skin Test (Equine)
(f) Allergenic Skin Test (Goat)
(g) Botulism Immune Globulin (Human). Recall #B-220/226-4.
CODE All lots.
MANUFACTURER University of Minnesota, Department of Surgery, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by telephone from September 29, 1993 - October
15, 1993, followed by letter dated October 11, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Canada, Denmark, New Zealand.
QUANTITY 2,581 vials retrieved from consignees at time of recall.
-3- REASON Investigational products, not manufactured in accordance
with approved Investigational New Drug applications, were
commercially distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-229-4.
CODE Unit numbers: A3875, A3880, A3894, A3896, A3901, A3913,
A3925, A3962, A3971, A3977, A3994, A3998, A4024, A4035,
A4077.
MANUFACTURER Verdugo Hills Hospital, Glendale, California.
RECALLED BY Manufacturer, by telephone November 11, 1993, followed by
letter November 23, 1993. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 15 units.
REASON Blood products, untested for hepatitis B surface antigen
(HBsAg), the antibodies to the human immunodeficiency virus
type 1/2 (anti-HVI-1/2), the antibody to hepatitis C virus
encoded antigen (ant9-HCV) hepatitis B core antigen (anti-
HBC), and syphilis were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall B-230/232-4.
CODE Unit #1512951.
MANUFACTURER Lifesource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter January 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the antibody to
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets, for
Further Manufacture. Recall #B-233/235-4.
CODE Unit numbers: (a) 01V10700: (b) 01E04823; (c) 01E04823.
MANUFACTURER The American National Red Cross, Rochester, New York.
RECALLED BY Manufacturer, by letters of: (a) April 26, 1993; (b)
February 27, 1992; (c) May 14, 1992. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 1 unit of each component.
REASON Blood products, that either: tested negative for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1), but were collected from a donor who previously
tested repeatedly reactive for anti-HIV-1; or tested
negative for the antibody to hepatitis B core antigen (anti-
HBc), but were collected from a donor who previously tested
repeatedly reactive for anti-HBc on more than one occasion,
were distributed.
-4- _______________
PRODUCT (a) Cryoprecipitated AHF; (b) Recovered Plasma.
Recall #B-236/237-4.
CODE Unit #24LJ96837.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
RECALLED BY Manufacturer, by telephone September 7, 1993, and by letters
of September 13 and 24, 1993. Firm-initiated recall
complete.
DISTRIBUTION Kentucky, Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the antibody to
hepatitis C virus encoded antigen (anti-HCV), but were
collected from a donor who previously tested repeatedly
reactive for anti-HCV, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-238/240-4.
CODE Unit #C25810.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
RECALLED BY Manufacturer, by telephone and Fax November 1, 1993,
followed by letter November 24, 1993. Firm-initiated recall
complete.
DISTRIBUTION Illinois, California.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for
hepatitis B surface antigen (HBsAg), were distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-242-4.
CODE Unit #E56802.
MANUFACTURER Regional Health Resource Center, Champaign, Illinois, by
telephone January 14, 1994, followed by letter February 8,
1994. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product labeled with an incorrect expiration date was
distributed.
_______________
PRODUCT Platelets. Recall #B-249-4.
CODE Unit #24GW40861.
MANUFACTURER The American National Red Cross, Louisville, Kentucky.
RECALLED BY telephone on or about March 18, 1993, followed by letter
April 15, 1993. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Blood product, that tested repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV),
was distributed.
-5- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells, for further manufacture; (b) Recovered
Plasma. Recall #B-218/219-4.
CODE Unit numbers: (a) 4596369; (b) 1352402, 1784113, 2886566,
5645218.
MANUFACTURER Bloodcare, Dallas, Texas.
RECALLED BY Manufacturer, by letters of September 14 and 22, 1993, and
January 11-12, 1994. Firm-initiated recall complete.
DISTRIBUTION Texas, New Jersey, Florida.
QUANTITY (a) 1 units; (b) 4 units.
REASON Blood products, collected from a donor who reported a
history of cancer, were distributed for further manufacture
of injectable and non-injectable products.
_______________
PRODUCT Red Blood Cells. Recall #B-241-4.
CODE Unit 3149372.
MANUFACTURER Central Texas Regional Blood Center, Austin, Texas.
RECALLED BY Manufacturer, by telephone February 19, 1993. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Autologous blood product, which was positive for syphilis
but was not labeled with a biohazard label, was distributed.
_______________
PRODUCT Source Plasma. Recall #B-248-4.
CODE Unit numbers: MXG889, MXG890, MXG894, MXG895, MXG896,
MXG897, MXG899, MXH902, MXH903, MXH908, MXH912, MXH914.
MANUFACTURER Austin Plasma Company, Inc., Austin, Texas.
RECALLED BY Manufacturer, by telephone October 25, 1993. Firm-initiated
recall complete.
DISTRIBUTION North Carolina.
QUANTITY 12 units.
REASON Blood products, untested for hepatitis B surface antigen
(HBsAg), the antibodies to human immunodeficiency virus
types 1 and 2 (anti-HIV-1/2), and the antibody to hepatitis
C virus encoded antigen (anti-HCV), were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
PRODUCT 3M Defib-Pad, conductive gel pads for defibrillation or
cardioversion:
(a) Catalog 2345N (9" x 4-1/2"); (b) Catalog #2346N
(9" x 6"). Recall #Z-299/300-4.
CODE All lots.
MANUFACTURER 3M Company, Brookings, South Dakota.
RECALLED BY 3M Health Care, St. Paul. Minnesota, by letters of January
29, 1994 and March 14, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
-6- QUANTITY 15,778 cartons (100 pads per carton) were distributed; firm
estimates 9,000 cartons remain on the market.
REASON Use of Defib-Pads which contain a polyethylene liner
inadvertently placed in between two layers of gel could
impede the current flow resulting in a risk of arcing,
fires, burns to patients, electrical shock, and possible
patient deaths due to the failure to defibrillate the
patient in a timely manner.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT MedFlo Ambulatory Infusion Device, sterile, nonpyrogenic
fluid path, a non-electronic positive pressure medication
delivery system. Recall #Z-247-4.
CODE Lot #93-323.
MANUFACTURER Secure Medical Products, Inc., Whitewater, Wisconsin.
RECALLED BY Secure Medical Products, Inc., Mundelein, Illinois, by
telephone January 17-20, 1994, followed by letter January
26, 1994. Firm-initiated recall complete.
DISTRIBUTION Arizona, California, Colorado, Florida, Illinois,
Massachusetts, Missouri, Pennsylvania, Texas, Washington
state.
QUANTITY 3,500 units were distributed.
REASON Cracking of the distal luer connection on some of the units.
_______________
PRODUCT Cynomolgus Monkey Kidney Cell Culture Tubes with SV-5 and
SV-40 antisera, for in-vitro diagnostic use.
Recall #Z-562-4.
CODE Lot numbers: 3C3987, 3C3909, 3C3910.
MANUFACTURER BioWhittaker, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by telephone January 18, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona, Connecticut, Georgia, Massachusetts, Ohio,
Pennsylvania, South Dakota, Tennessee, Maryland, Texas, New
Jersey.
QUANTITY 255 units of lot 3C3909; 150 units of lot 3C3987, and 1,110
units of lot 3C3910 were distributed.
REASON Product was contaminated with Simian B Virus.
_______________
PRODUCT Rubestat Test Kit, used for the purpose of evaluating a
Patient's serologic status to rubella virus infection or to
evaluate paired sera for the presence of a significant
increase in a specific IgG as indicative of a recent or
current rubella virus infection: (a) Catalog #30-334U;
(b) Catalog #30-336U. Recall #Z-563/564-4.
CODE Lot numbers: (a) 2E1627, 2E1780, 2E1985, 3E0060, 3E0177,
3E0560, 3E0592, 3E0627, 3E0757, 3E0910, 3E1101, 3E1103,
3E1206, 3E1603; (b) 2E2018, 2E2053, 3E0227, 3E0588, 3E0858,
3E0945.
-7- MANUFACTURER BioWhittaker, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by letter February 4, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,228 units of lot 30-334U, and 1,291 units of lot 30-336U
were distributed.
REASON False positive reactions which may result in non-immune
samples being classified incorrectly as immune.
_______________
PRODUCT Renasol Acid Concentrate, Catalog #SB-1059, hemodialysis
concentrate. Recall #Z-610-4.
CODE All product produced prior to January 15, 1994.
MANUFACTURER Renal Systems, Division Minnetech Corporation, Plymouth,
Minnesota.
RECALLED BY Manufacturer, by letter February 1, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Kentucky, Mississippi, New Jersey, New York,
Texas, Wisconsin.
QUANTITY 2,200 55-gallon drums and 11,364 cases (4 gallons per case)
were distributed from November 1990 to January 15, 1994.
REASON A higher than expected amount of potassium will be in the
concentrate and dialysate.
_______________
PRODUCT William Harvey Two-Stage Venous Cannulae, size 36/51F,
designed for single tube venous drainage from the right
atrium and vena cava during cardiopulmonary bypass surgery.
Recall #Z-613-4.
CODE Catalog #TS3651, lot #28FDX601.
MANUFACTURER Bard Cardiopulmonary Division, C.R. Bard, Inc., Tweksbury,
Massachusetts.
RECALLED BY Manufacturer, by letter dated October 20, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION California, New York, Connecticut, New Jersey, Oregon,
Kansas, Alabama, Virginia, Washington, D.C., Minnesota,
Japan, Italy, France.
QUANTITY 193 units were distributed.
REASON The distal tip of the cannulae may partially or totally
detach and migrate during cardiopulmonary bypass surgery.
_______________
PRODUCT Becton Dickinson 3 cc Safety-Lok Syringes, intended for use
to administer injections:
(a) Catalog #9606; (b) Catalog #9592; (c) Catalog #9593;
(d) Catalog #9594; (e) Catalog #9595; (f) Catalog #9596.
Recall #Z-614/619-4.
CODE All lot numbers beginning with 2M, 3A, 3B, 3C, and 3D.
MANUFACTURER Becton Dickinson Division, Columbus, Nebraska.
RECALLED BY Becton Dickinson and Company, Franklin Lakes, New Jersey, by
letter April 21, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
-8- QUANTITY 4,430,100 units were distributed; firm estimates 48 percent
of product remained on market at time of recall initiation.
REASON An insufficient weld or a missing component on the locking
collar may cause the safety shield to separate from the
syringe.
_______________
PRODUCT Infant Radiant Warmers, used for resuscitation of premature
babies:
(a) Borning Stabilet Model #200;
(b) Borning Stabilet Model #300;
(c) Hill-Rom Stabilet Model #2000/3000;
(d) Hill-Rom Stabilet Model #2200/3200;
(e) Hill-Rom Stabilet Model #1500;
(f) Hill-Rom Stabilet Model #1250. Recall #Z-677/682-4.
CODE All units.
MANUFACTURER Med*Ex Diagnostics of Canada, Inc., Coquitlam, British
Columbia, Canada.
RECALLED BY Hill-Rom Company, Inc., Batesville, Indiana, by letter
beginning November 30, 1993 and ending February 28, 1994.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 3,116 units were distributed.
REASON The heater contacts have the potential for arcing due to
fretting corrosion that may result in small pieces of molten
metal falling on to the bed, and/or patient.
_______________
PRODUCT Burdick Defibrillators: (a) Model DC-170; (b) Model DC-180;
(c) Model DC-185; (d) Model DC-190. Recall #Z-705/708-4.
CODE Serial numbers: Units manufactured after July 24, 1984 and
units which had their logic boards replaced between July 24,
1994, and November 26, 1991. Serial numbers: (a) All
units; (b) 18049, 18164, 18172 to 18211; (c) 21007, 21047,
21049 to 21051; (d) 10786 to 13632.
MANUFACTURER Burdick, Inc., Milton, Wisconsin.
RECALLED BY Manufacturer, by letter dated January 17, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 3,000 units.
REASON The resistor in the units can fail resulting in failure of
the devices to discharge.
_______________
UPDATE Recall #Z-810/813-3, Infant Radiant Warmers, recalled by
Hill-Rom Company, Inc., Batesville, Indiana, which appeared
in the January 19, 1994 Enforcement Report has been
withdrawn. Hill-Rom initially reported that they planned to
recall due to a problem that the supplier could no longer
furnish replacement parts for the cross-over valve. After
publication of the recall, the firm contacted FDA and
-9- indicated that they never implemented the recall, because
they found out that their supplier could continue to supply
the cross-over valve.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Bausch & Lomb Medalist Toric Contact Lenses.
Recall #Z-586-4.
CODE Carton lot numbers: S0040878, S0040882, 20046171, S0040881,
S0045039, S0040882, S0040869, S0040870, S0046575, S0045499,
S0040871, S0045498, S0045502, S0044429, S0040868.
MANUFACTURER Bausch & Lomb, Inc., Sarasota, Florida.
RECALLED BY Bausch & Lomb, Inc., Rochester, New York, by letter February
25, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 58 blister packs were distributed.
REASON Products are labeled with the wrong sphere and axis
parameters.
_______________
PRODUCT Thomson/Shelton Instrumentation Company's End Cutter, a
manual surgical instrument, approximately 2-1/2' in length,
used during spinal procedures to cut implants/plates, wires
that remain in the body. Recall #Z-592-4.
CODE Serial #TS24-101-10.
MANUFACTURER Semco, Arlington, Texas (contract manufacturer).
RECALLED BY Thomsom/Shelton Instrumentation Company, Rockwall, Texas, by
telephone on or about December 6, 1991. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY Firm estimates none remains on the market.
REASON The magnaplate finished coating, on the inside of the
cutting jaws, was peeling and flaking.
_______________
PRODUCT Illumen 8 PTC Guiding Catheter with Flexguard FR Inferior
4.0 Curve, femoral guiding catheters designed for use in the
cardiovascular system to provide a pathway through which
USCI coronary balloon dilatation catheters are introduced.
Recall #Z-643-4.
CODE Item #016264, lot #08JC0381.
MANUFACTURER USCI Division C.R. Bard, Inc., Billerica, Massachusetts.
RECALLED BY Manufacturer, by telephone starting August 6, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 47 units were distributed; firm estimates none remains on
the market.
REASON The product labeling identifies the product as Illumen 8
with Flexguard FR Inferior 4.0 Curve, but the actual product
enclosed is an illumen 8 Amplatz Curve.
-10- _______________
PRODUCT Silipos Silosheaths, a prosthetic sheath used for leg
amputees to help eliminate abrasion on the residual limb:
(a) Product #1210 - Short/Regular
(b) 1211 - Short/Narrow
(c) 1215 - Medium/Regular
(d) 1216 - Medium/Narrow
(e) 1217 - Medium/Wide
(f) 1220 - Long/Regular
(g) 1221 - Long/Narrow
(h) 1225 - Short/Active
(i) 1226 - Short/Narrow Active
(j) 1230 - Medium/Regular Active
(k) 1231 - Medium/Narrow Active
(l) 1232 - Medium/Wide Active
(m) 1235 - Long/Regular Active
(n) 1236 - Long/Narrow Active. Recall #Z-658/671-4.
CODE Date code 103 or lower.
MANUFACTURER Silipos, Inc., Niagara Falls, New York.
RECALLED BY Silipos, Inc., New York, New York, by letters in October
1993, and by letter dated February 24, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Holland, Canada, Switzerland, Israel, Spain,
Belgium, Germany, France, Australia.
QUANTITY Approximately 1,200 units were distributed with possibly 1%
remaining on the market.
REASON A packaging problem can result in the gel on one side of the
sheath cracking, possibly causing discomfort to the user.
_______________
PRODUCT Quickread Analyzer, for in-vitro diagnostic use. The
product is an assay processor when used in conjunction with
the Whole Blood Cholesterol Adult and Pediatric invitro kit,
the HDL Cholesterol Invitro Kit, and the Triglyceride
Invitro kit. Recall #Z-672-4.
CODE Model #K0106. All serial numbers.
MANUFACTURER Medical Technology Corporation, Waldwick, New Jersey (no
longer in business).
RECALLED BY Orion Diagnostica, Inc., Somerset, New Jersey (responsible),
by telephone August 1, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 140 units were distributed.
REASON Machines were out of calibration.
_______________
PRODUCT Abbott IMx CEA Reagent, an in-vitro diagnostic microparticle
enzyme immunoassay (MEIA) for the quantitative determination
of carcinoembryonic antigen (CEA) in serum or plasma on the
IMx Analyzer. Recall #Z-673-4.
CODE Lot numbers: 69778M200 EXP 1/8/93, 66078M100 EXP 1/21/93,
71178M200 EXP 1/30/93.
-11- MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone November 19, 1992, and January 4,
1993, followed by letter December 31, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 1,330 kits were distributed; firm estimates none remains on
the market.
REASON The device has a potential for increasing rate readings over
time which may result in calibration curve failures.
_______________
PRODUCT Labeling for "Time Endured Favorites" style Tropic Cal brand
men's sunglasses. Recall #Z-674-4.
CODE Catalog with SKU numbers "M 66330346 and M 66330482.
MANUFACTURER Outlook Eyeware Company, San Antonio, Texas
(relabeler/repacker).
RECALLED BY Outlook Eyewear Company, subsidiary of Bausch & Lomb, Inc.,
Broomfield, Colorado, by telephone February 9, 1994, and by
letter dated March 21, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Texas, Utah.
QUANTITY 4,902 pairs were distributed between December 21, 1993 and
February 8, 1994.
REASON The labeled hangtags state that the sunglasses are "FDA
Approved".
______________
PRODUCT Teflon Coated Movable Core Peripheral Guidewire, diameter -
0.035", length - 145 cm, used to negotiate a patient's
vascular system in order to facilitate procedures such as
balloon angioplasty. Recall #Z-686-4.
CODE Product #TM35145IT7, lot #01-001181.
MANUFACTURER Lake Region Medical, Inc., Pittsburgh, Pennsylvania.
RECALLED BY Schneider (USA), Inc., Pfizer Hospital Products Group,
Minneapolis, Minnesota, by letter February 24, 1994. Firm-
initiated recall complete.
DISTRIBUTION Delaware, Florida, Minnesota, Nevada, Tennessee, Texas.
QUANTITY 210 units were distributed.
REASON The size of the core handle for an unknown number of the
guidewires were incorrect (0.038" instead of 0.035"). This
manufacturing miscue can and has resulted in the guidewire
getting stuck in the catheter it is placed through.
_______________
PRODUCT Abbott TDx/TDXFLx 5-HIAA (Urine) Reagent Kit, an in-vitro
test for use in the TDx or TDxFLx System to quantitate 5-
HIAA (5-Hydroxy-3-Indole Acetic Acid) in human urine.
Recall #Z-687-4.
CODE List #9837-47. Master lot #67091SV (Reagent lot #68027SV)
EXP 1/93; Master lot #69437M200 (Reagent lot #69436M200) EXP
3/93.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
-12- RECALLED BY Manufacturer, by telephone January 28-29, 1993, and by
letters dated February 1993, and March 24, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 643 kits were distributed.
REASON There was a potential for under-recovery on urine patient
samples, proficiency survey material and non-Abbott controls
of up to 80%.
_______________
PRODUCT Abbott Estradiol Calibrators, Controls and Reagents:
(a) Abbott IMx Estradiol Calibrators; for calibration of the
Imx Analyzer when used for the quantitative determination of
Estradiol in serum or plasma, list #2215-01; 6 4-ml bottles
per box;
(b) Abbott IMx Estradiol Controls; for verification of the
calibration of the Imx Analyzer when used for the
quantitative determination of Estradiol in serum or plasma;
list #2215-10, 3 8-ml bottles per box;
(c) Abbott IMx Estradiol Reagent; an in-vitro diagnostic
microparticle enzyme immunoassay (MEIA) for the quantitative
determination of Estradiol in serum or plasma on the IMx
Analyzer; list #2215-20; 100 test kits.
Recall #Z-697/699-4.
CODE (a) Lot #64579M100 EXP 6 DEC 92, 66831M200 EXP 30 JAN 93,
68123M100 EXP 17 FEB 93, 70770M300 EXP 3 DEC 92;
(b) Lot #64580M100 EXP 6 DEC 92, 66948M200 EXP 30 DEC 92,
67476M300 EXP 17 FEB 93 70773M300 EXP 3 DEC 92;
(c) Lot #66960M200 EXP 6 DEC 92, 66961M200 EXP 6 DEC 92,
68884M200 EXP 6 JAN 93, 68885M200 EXP 6 JAN 93, 69524M300
EXP 17 FEB 93, 69893M100 EXP 26 JAN 93, 69893M101 EXP 26 JAN
93, 70779M200 EXP 17 FEB 93.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone November 20-23, 1992, and by FAX
November 10 and 19, 1992, followed by letter November 18,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,498 calibrator packs, 2,622 control packs and 5,010
reagent kits were distributed.
REASON Products lose potency overtime due to presence of residual
charcoal in the human serum matrix. This may result in
controls failing assay specifications.
_______________
PRODUCT Abbott Estradiol Calibrator, Control and Reagent Pack:
(a) Abbott IMx Estradiol Calibrators; for calibration of the
Imx Analyzer when used for the quantitative determination of
Estradiol in serum or plasma, list #2215-01, 6 4-ml bottles
per box;
-13- (b) Abbott IMx Estradiol Controls; for verification of
the calibration of the Imx Analyzer when used for the
quantitative determination of Estradiol in serum or plasma
list #2215-10, 3 8-ml bottles per box;
(c) Abbott IMx Estradiol Reagent Pack, an in-vitro
diagnostic microparticle enzyme immunoassay (MEIA) for the
quantitative determination of Estradiol in serum or plasma
on the IMx Analyzer, list #2215-20, 100 test kits.
Recall #Z-700/702-4.
CODE (a) Lot #71575M200 EXP 20 JUN 93, 72320M200 EXP 04 JUL 93;
(b) Lot #71576M200 EXP 21 JUN 93, 72977M200 EXP 21 JUL 93;
(c) Lot #74609M300 EXP 20 JUN 93.
MANUFACTURER Abbott Laboratories, Diagnostics Division, Abbott Park,
Illinois.
RECALLED BY Manufacturer, by telephone May 19, 1993, followed by letter
May 17, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,678 calibrator packs, 1,787 control packs, and 533 reagent
kits were distributed.
REASON The calibration and control material contained in these
devices lose potency overtime due to possible oxidation of
the estradiol molecule. This may result in controls failing
assay specification.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Master Mix brand Master Sow 15 Plus 835, a non-medicated
animal feed packed in 50 pound paper bags. Recall #V-041-4.
CODE 835-00-2 manufactured 9/10/93.
MANUFACTURER Central Soya Company, Inc., Marion, Ohio.
RECALLED BY Manufacturer, by telephone October 8, 1993. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 81 bags were distributed; firm estimates none remains on the
market.
REASON Feed contaminated with sulfamethazine due to inadequate
clean out procedures.
MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Pulse Generators:
(a) Medtronic Synergyst Model 7026 Pulse Generator;
(b) Medtronic Synergyst II Model 7070 Pulse Generator;
(c) CPI Triumph DR Model 1224. Safety Alert #N-047/049-4.
CODE All serial numbers.
MANUFACTURER Medtronic, Inc., Minneapolis, Minnesota.
ALERTED BY Manufacturer, by letter February 18, 1994.
DISTRIBUTION Nationwide and international.
QUANTITY 25,275 units were distributed.
REASON Ventricular output from the pacemakers can be suppressed and
lost when atrial lead impedance is low.
-14- _______________
UPDATE Safety Alert #N-036/038-4, DHD Ace Aerosol Cloud Enhancers,
manufactured by Diemolding Healthcare Division, Canastota,
New York, which appeared in the March 2, 1994 Enforcement
Report, is being amended to include the following lot
numbers:
Reorder #DHD 11-1010, lot numbers: 135480, 135613, 139053,
157590, 166294, 172206, 181345, 191269, 197824, 203193,
210653.
Reorder #DHD 11-1020, lot numbers: 135475, 135476, 135614,
137552, 157595, 166301, 177069, 185494, 189434, 189435,
196228, 197409, 199319, 205973, 205974, 215401, 221470.
-15-
END OF ENFORCEMENT REPORT FOR MAY 4, 1994. BLANK PAGES MAY FOLLOW.
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