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
05/06/1992
RECALLS AND FIELD CORRECTIONS: May 6, 1992
92-19
FOODS -- CLASS I
PRODUCT Chocolate Peanut Butter Swirl flavored Ice Cream Bars.
Recall #F-258-2.
CODE PN CHOCOLATE SAND 5592 printed on top of shipping carton.
MANUFACTURER Dairy Mark, Inc., Cuyahoga Falls, Ohio.
RECALLED BY Manufacturer, by telephone. Firm-initiated recall complete.
DISTRIBUTION Ohio, Massachusetts.
QUANTITY 78 cases were distributed.
REASON Product contains undeclared peanuts.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
PRODUCT Heinz Tomato Juice, in 5-1/2 fluid cans. Recall #F-273-2.
CODE Lot #2511/C2J2.
MANUFACTURER H.J. Heinz Company of Canada, Leamington Ontario, Canada.
RECALLED BY Wegmans Food Pharmacy, Rochester, New York, by memorandum
March 27, 1992. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 587 cases (8 6-packs per case) were distributed.
REASON Product is contaminated with mold and the net contents
declaration is not expressed in the required terms and/or
format.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Dicopac B12 Absorption Assay Kits, a radiopharmaceutical
in-vivo diagnostic used to assess vitamin B12 absorption.
Recall #D-330-2.
CODE CT.312PA (2-test kit) and CT.315PA (5-test kit, lot #160 EXP
6/15/92.
MANUFACTURER Amersham Labs, Amersham, Buckinghampshire, England.
RECALLED BY Medi-Physics, Inc., an Amersham Company, Arlington Heights,
Illinois, by telephone April 21, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 129 2-test kits and 146 5-test kits were distributed.
REASON The radiochemical purity is below specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT (a) Nystatin Tablets, 100,000 units/tablet, vaginal
prescription, in 15 and 30 tablet boxes; (b) Nystatin Topical
Cream, 100,000 units/gram, dermatologic prescription, in 240
gram bottles. Recall #D-327/328-2.
CODE Lot numbers: (a) 256-377, 268-309, 274-351, 274-330, 274-329,
300-166, 268-310; (b) 278-479, 280-346, 280-347, 286-197.
MANUFACTURER Lederle Laboratories, Division of American Cyanamid Company,
North Pearl River, New York.
RECALLED BY Manufacturer, by letter during the first week of March 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 5,215 units; (b) 34,395 units; (c) 1,329 units were
distributed.
REASON Potency not assured through expiration date.
PRODUCT Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg, in
100 and 500 tablet bottles, a Rx drug for relief of pain.
Recall #D-329-2.
CODE Lot numbers and EXP dates: 9C229AO 4/92, 9J229BL 11/92,
0B229DY 3/92, 1F229AZ 7/94, 1G229DK 7/94, 1I229DN 10/94,
1I229DO 10/94, 1I229DP 11/94.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Barr Laboratories, Inc., Pomona, New York, by letter April 1,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 5,215 units; (b) 34,395 units; (c) 1,329 units were
distributed.
-2-
REASON Product fails content uniformity specifications.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Red Blood Cells. Recall #B-254-2.
CODE Unit #2317315.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by letter September 3, 1991. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Blood product which tested negative for the antibody to human
T lymphotropic virus type I (anti-HTLV-1), but was collected
from a donor who previously tested repeatedly reactive for
anti-HTLV-1, was distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Cryoprecipitated AHF; (e) Recovered Plasma. Recall
#B-259/263-2.
CODE: Unit numbers: (a) 39E11471, 39F00588, 39F00954, 39F01548,
39F01767, 39F02984 39F03678, 39F04297, 39F05176, 39F08443,
39F08487, 39F10266, 39F10356, 39F10492, 39F14667, 39F16396,
39F17937, 39F22951, 39F24128, 39F24684, 39F25404, 39F26618,
39F31110, 39F32380, 39F34179, 39F34325, 39F36657, 39F50977,
39F92136, 39F93419, 39F94346, 39F94532, 39F94586, 39F95528,
39F95536, 39F96157, 39F97421, 39F97674, 39F98105, 39F98122,
39F98309, 39F99184, 39F99300, 39G00002, 39G01118, 39G06167,
39G08961, 39G08982, 39G11906, 39G15870, 39G28037, 39G28455,
39G41314, 39G42762, 39G44645, 39G45590, 39G46881, 39G51639,
39G54984, 39G59776, 39G65771, 39G74531, 39G75967, 39G78065,
39G79374, 39G85426, 39G87272, 39G90660, 39G93900, 39G95392,
39G96939, 39H02115, 39H06465, 39H07935, 39H08857, 39H12150,
39H12795, 39H13837, 39H14144, 39H15496, 39H15753, 39H22495,
39H27089, 39H28680, 39H54679, 39J05983, 39J37267, 39J42857,
39J43208, 39J48322, 39J52792, 39J54470, 39J56555, 39J57400,
39J62777, 39J96135, 39K38680, 39K39883, 39K39975, 39K41113,
39K42542, 39K44773, 39K45520, 39M18819, 39M19321, 39M19868,
39M20353, 39M20757, 39M21217, 39M21646, 39M21712, 39M22061,
39M22141, 39N13892, 39X29823, 39X29971, 39X30480, 39Y24574,
39Y27760
(b) 39E11471, 39F00588, 39F00954, 39F01548, 39F01767, 39F02984,
39F03678, 39F04297, 39F05176, 39F08443, 39F08487, 39F10266,
39F10356, 39F10492, 39F14667, 39F16396, 39F17937, 39F22951,
39F24128, 39F25404, 39F26618, 39F31110, 39F32380, 39F34179,
39F34325, 39F36657, 39F92136, 39F93419, 39F94346, 39F94532,
39F94586, 39F95528, 39F95536, 39F96157, 39F97421, 39F97674,
39F98105, 39F98122, 39F98309, 39F99184, 39F99300, 39G11906,
39G28037, 39G41314, 39G42762, 39G44645, 39G45590, 39G74531,
39G75967, 39G93900, 39H02115, 39H06465, 39H07935, 39H08857,
-3-
39H12150, 39H12795, 39H13837, 39H14144, 39H15496, 39H15753,
39H54679, 39J05983, 39J57400, 39K45520, 39N13892, 39Y24574,
39Y27760
(c) 39F01548, 39F01767, 39F02984, 39F03678, 39F04297, 39F05176,
39F24684, 39F94346, 39F94586, 39F95528, 39F95536, 39F96883,
39F97421, 39F98122, 39F99300, 39G11906, 39G93900, 39H02115,
39H07935, 39H12795, 39H13837, 39H14144, 39H15496, 39H15753,
39H54679, 39J62777, 39N13892
(d) 39F08443, 39F08487, 39F10266, 39F10356, 39F10492, 39F14667,
39F16396, 39F17937, 39F22951, 39F25404, 39F26618, 39F31110,
39F32380, 39F34179, 39F34325, 39F36657, 39G41314, 39Y24574
(e) 39F00588, 39F00954, 39F08443, 39F08487, 39F10266, 39F10356,
39F10492, 39F14667, 39F16396, 39F17937, 39F19745, 39F22951,
39F24128, 39F25404, 39F26618, 39F31110, 39F32380, 39F34179,
39F34325, 39F36657, 39F50977, 39F92136, 39F93419, 39F94532,
39F96157, 39F97674, 39F98105, 39F98309, 39F99184, 39G00002,
39G01118, 39G06167, 39G08961, 39G08982, 39G15870, 39G28037,
39G28455, 39G41314, 39G42762, 39G44645, 39G45590, 39G46881,
39G51639, 39G54984, 39G59776, 39G65771, 39G74531, 39G75967,
39G78065, 39G79374, 39G85426, 39G87272, 39G90660, 39G95392,
39G96939, 39H06465, 39H08857, 39H12150, 39H22495, 39H28680,
39J05983, 39J37267, 39J42857, 39J43208, 39J48322, 39J52792,
39J54470, 39J56555, 39J57400, 39J79275, 39J96135, 39K38680,
39K39883, 39K39975, 39K41113, 39K42542, 39K44773, 39K45520,
39M18819, 39M19321, 39M19868, 39M20353, 39M20757, 39M21217,
39M21646, 39M21712, 39M22061, 39M22141, 39X29823, 39X29971,
39X30480, 39Y24574, 39Y27760.
MANUFACTURER American Red Cross, Tri-State Region, Huntington, West
Virginia.
RECALLED BY Manufacturer, by telephone on or about November 7, 1991,
followed by letters dated November 7 and 12, 1991, December
12, 1991. Firm-initiated recall ongoing.
DISTRIBUTION West Virginia, Kentucky, Ohio, Pennsylvania, Florida,
Oklahoma, South Carolina, New Jersey, Illinois, California,
Switzerland.
QUANTITY (a) 119; (b) 67; (c) 27; (d) 18; (e) 93 units were distributed.
REASON Blood components, which tested negative for antibody to the
human immunodeficiency virus, type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
PRODUCT 4N Sulfuric Acid (H2S04) for Ortho Elisa Test System 150 ml.
Recall #B-269-2.
CODE Lot #1094 EXP 4/93.
MANUFACTURER Biochemical Science, Bridgeport, New Jersey.
RECALLED BY Ortho Diagnostic Systems, Inc., Raritan, New Jersey, by letter
February 17, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 104 packages were distributed.
REASON 4N sulfuric acid stop solution, which caused invalidation of
test runs in the Ortho ELISA Test System due to contamination
with iron, an oxidizing agent, was distributed.
-4-
PRODUCT Source Plasma. Recall #B-270-2.
CODE Unit #E07602-173.
MANUFACTURER First Coast Plasma, Inc., Jacksonville Beach, Florida.
RECALLED BY Manufacturer, by letter May 29, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Source Plasma, which tested negative for hepatitis B surface
antigen (HBsAg) but was collected from a donor who previously
tested reactive for HBsAg, was distributed.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-271/272-2.
CODE Unit numbers: (a) J64387; (b) J53304, J64387.
MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora,
Illinois.
RECALLED BY Manufacturer, by letter March 23, 1992. Firm-initiated recall
complete.
DISTRIBUTION Illinois, California.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products, which tested negative for the antibody to
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
PRODUCT Recovered Plasma. Recall #B-274-2.
CODE Unit numbers: 16F06609, 16F14872, 16F20379, 16F23787,
16F27238, 16F37765, 16F82679, 16F86753, 16F92797.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, on February 22, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION California.
QUANTITY 9 units.
REASON Units of recovered plasma, which tested negative for hepatitis
B surface antigen(HBsag), but were collected from a donor who
previously tested repeatedly reactive for HBsAg, were
distributed.
PRODUCT Red Blood Cells. Recall #B-275-2.
CODE Unit numbers 1286307, 1286308, 1292270.
MANUFACTURER Central Texas Regional Blood Center, Austin, Texas.
RECALLED BY Manufacturer, by letters of September 17, 1991, and November
15, 1991. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 3 units.
REASON Blood products, testing either repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV), or
negative for anti-HCV but collected from a donor who
previously tested repeatedly reactive for anti-HCV, were
distributed.
-5-
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-276/279-2.
CODE Unit numbers: (a) 05N21236, 05N25253; (b) 05N25253; (c)
05N25253; (d) 05N21236.
MANUFACTURER American Red Cross Blood Services, Washington, D.C.
RECALLED BY Manufacturer, by letters of June 18 and 26, 1991.
Firm-initiated recall complete.
DISTRIBUTION Maryland, Virginia, California.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 1 unit.
REASON Blood products, collected from a donor who previously tested
repeatedly reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1), were distributed.
PRODUCT Platelets. Recall #B-280-2.
CODE Unit #1825890.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone December 30, 1991. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who previously tested
repeatedly reactive for anti-HIV-1, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets; (d) Fresh
Frozen Plasma; (e) Recovered Plasma. Recall #B-264/268-2.
CODE Unit numbers: (a) 39J55658, 39K41672
(b) 39F93168, 39F94197, 39F95260, 39F96883, 39F98484, 39H15797,
39H15884, 39J28125, 39J43223, 39J50064, 39J51406, 39J53801,
39J54723, 39J52788, 39J57543, 39J59809, 39J94493, 39K39872,
39J54723, 39J52788, 39J57543, 39J59809, 39J94493, 39K39872,
39K40851, 39K42388, 39K44224, 39K46672, 39M20852, 39M21259,
39M21771
(c) 39F93168, 39F94197, 39F95260, 39F96883, 39F98484, 39H15797,
39H27089, 39J51406
(d) 39F93168, 39F94197, 39F95260, 39F98484, 39H15797, 39H15884,
39H27089
(e) 39J28125, 39J43223, 39J50064, 39J51406, 39J52788, 39J53801,
39J54723, 39J57543, 39J59809, 39J94493, 39K39872, 39K40851,
39K42388, 39K44224, 39K46672, 39M20852, 39M21259, 39M21771.
MANUFACTURER American Red Cross, Tri-State Region, Huntington, West
Virginia.
RECALLED BY Manufacturer, by telephone on or about November 7, 1991,
followed by letters dated November 7 and 12, 1991, December
12, 1991. Firm-initiated recall ongoing.
DISTRIBUTION West Virginia, Kentucky, Ohio, Pennsylvania, Florida,
Oklahoma, South Carolina, New Jersey, Illinois, California,
Switzerland.
-6-
QUANTITY (a) 2; (b) 25; (c) 8; (d) 7; (e) 18 units were distributed.
REASON Blood components, which tested negative for antibody to the
human immunodeficiency virus, type 1 (anti-HIV-1), but were
collected from donors who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
PRODUCT Platelets. Recall #B-273-2.
CODE Unit #29-096-1750.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone December 9, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON A unit of platelets, prepared more than eight hours after
collection of the whole blood unit, was distributed.
PRODUCT Red Blood Cells. Recall #B-281-2.
CODE Unit numbers: 7014726, 7014727.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone August 20, 1991. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Blood product labeled with an incorrect expiration date was
distributed.
PRODUCT Plasma. Recall #B-282-2.
CODE Unit #KK98806.
MANUFACTURER Richmond Metropolitan Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter February 18, 1992. Firm-initiated
recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit.
REASON Plasma, labeled as Fresh Frozen Plasma, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Lasermatic Super Combo (also known as Lasermatic Combolaser),
used for surgery. Recall #Z-268-2.
CODE Serial numbers: None.
MANUFACTURER Lasermatic, Inc., Dallas, Texas.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
January 2, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Undetermined.
QUANTITY 2 units were distributed.
REASON Noncompliance with the performance standard for laser products
in that its user manual failed to provide procedure and
schedule for calibration of the incorporated measurement
system.
-7-
PRODUCT Model Optica 60 Surgical Laser. Recall #Z-321-2.
CODE Serial numbers: None.
MANUFACTURER Xintec Corporation, Oakland, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
February 4, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Virginia.
QUANTITY 2 units were distributed.
REASON Noncompliance with performance standard for laser products in
that the manufacturer failed to provide a procedure and
schedule for recalibration of the incorporated measurement
system.
PRODUCT Dymer 200+ Excimer Laser Angioplasty System, used for
angioplasty. Recall #Z-322-2.
CODE Serial numbers: None.
MANUFACTURER Advanced Interventional Systems, Inc., Irvine, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
January 28, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 57 units were distributed.
REASON Noncompliance with performance standard for laser products in
that the operator's manual failed to contain a procedure and
schedule for recalibration of the incorporated measurement
system.
PRODUCT Intramedullary Alignment Guide. Recall #Z-363-2.
CODE Serial numbers: 6787300, 70044800, 67923700, 71062200,
67905100, 70905700, 69879800, 69189990, 67901100, 70380100.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by letter November 15, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 529 pieces were distributed.
REASON Rod separates from the body.
PRODUCT Respitrace Plus Monitoring System, Versions 1.7 or less.
Recall #Z-364-2.
CODE Serial numbers: None.
MANUFACTURER Non-Invasive Monitoring Systems, Miami Beach, Florida.
RECALLED BY Manufacturer, by letter September 6, 1991. Firm-initiated
field correction complete.
DISTRIBUTION Texas, Washington state, Colorado, Florida, Ohio, Virginia,
Minnesota, California, Louisiana, Massachusetts, Georgia,
Kansas, Pennsylvania.
QUANTITY 42 units were distributed.
REASON There is a software problem affecting the alarms for high and
low heart rates, low breath volume, high breath rate, and high
labored breathing index. When the problem occurs, the analog
and visual data are correct; however, there is no audible
alarm.
-8-
PRODUCT Uroview 2000 System, an integrated x-ray imaging and patient
positioning system for use in a variety of urological
diagnostic and surgical applications. Recall #Z-562-2.
CODE Serial numbers: T2-2001 through 2011, T9-2095 through 2109,
T2-2013 through 2024, T9-2111 through 2132, T2-2026 through
2028, T9-2134 through 2154, T2/T9 - 2028, T9-2156 through
2159, T9-2001 through 2016
T9-2161 through 2166, T9-2018, T9-2168, T9-2019, T9-2169,
T9-2021 through 2026, T9-2171, T9-2028 through 2034, T9-2173,
T9-2036 through 2053, T9-2175-2182, T9-2055 through 2060,
T9-2185, T9-2062 through 2081
T9-2186, T9-2090 through 2092. NOTE: Serial number T2/T9-2028
indicates that the unit originally went out with a nine-inch
Image Intensifier but the customer decided that a 12-inch
Image Intensifier was more appropriate for their purposes.
The unit was refitted with a 12-inch intensifier. Missing
serial numbers are units that were shipped internationally or
are still in the possession of OEC-Diasonics.
MANUFACTURER OEC Diasonics, Salt Lake City, Utah.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
March 20, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 191 units were distributed.
REASON Noncompliance with performance standard for x-ray products
in that the device does not meet the requirements for
light illuminance; the system did not provide a mode of
operation which limited the spot-film size to the fluoroscopic
field size when the fluoroscopic field size was smaller than
the selected spot-film field size; and some units were
defective in that image reversal could occur without
operator awareness.
PRODUCT Gelfoam Sterile Powder (absorbable gelatin powder), used as a
hemostatic device. Recall #Z-618-2.
CODE All lots.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter April 8, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 329,185 jars were distributed.
REASON The device was being promoted for bone hemostasis without an
approved premarket application.
PRODUCT Corpak Bower PEG Feeding with Internal Retention Balloon with
Elastic Foam, 20 Fr, a sterile Rx device for percutaneous
endoscopic gastrostomy procedures:
(a) Reorder No. 30-5020 20 Fr. Bower PEG Kit
(b) Reorder No. 30-4020 20 Fr. Bower PEG Kit - Push Technique;
-9-
(c) Reorder No. 30-6020 20 Fr. Bower-Ring Kit ;
(d) Reorder No. 30-5520 20 Fr. Bower Basic PEG Kit.
Recall #Z-622/625-1.
CODE (a) all lots except A49BA and A50BA; (b) all lots except A04BP;
(c) all lots except A02BH; (d) All lots.
MANUFACTURER Corpak, Inc., Wheeling, Illinois.
RECALLED BY Manufacturer, by letter January 17, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,500 kits were distributed.
REASON The devices contain a defective retention balloon seal which
could result in balloon failure (separation of the balloon
from the feeding tube.
PRODUCT Argyle Spinal Anesthesia Trays, 25 gage, containing various
drugs and medical devices for use in spinal anesthesia:
(a) Catalog #8888-826123, containing 1% Tetracaine HCl
Injection plus 10% Dextrose Injection;
(b) Argyle Spinal Anesthesia Tray, Catalog #8888-828129,
containing Marcaine Spinal. Recall #Z-626/627-2.
CODE 530368.
MANUFACTURER Sherwood Medical Company, St. Joseph, Missouri (assembler).
RECALLED BY Sherwood Medical Company, St. Louis, Missouri, by telephone
and letter April 9, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Pennsylvania, West Virginia, Michigan,
Illinois, Missouri, Louisiana, Arizona, Texas, California.
QUANTITY 875 trays were distributed.
REASON The trays marked as lot 530368 may have been labeled
mistakenly under two different catalog numbers. As a result,
trays labeled as catalog #8888-828129 state that the tray
contains a 2 ml ampule of Marcaine Spinal, when in fact these
trays contain a 2 ml ampule of 1.0% Tetracaine HCl Injection
plus a 3 ml ampule of 10% Dextrose Injection.
PRODUCT Hall Trama Drill. Recall #Z-634-2.
CODE Serial numbers: 2814, 2815, 2817, 2818, 2820, 2821.
MANUFACTURER Hall Surgical, Division of Zimmer, Carpinteria, California.
RECALLED BY Manufacturer, by telephone May 17, 1991, followed by letter
May 23, 1991. Firm-initiated recall complete.
DISTRIBUTION Alabama, Florida, Iowa, Oregon, Texas.
QUANTITY 6 units were distributed.
REASON The drill may run on after the trigger is released.
PRODUCT CDI QUIK-CELLS - component of System 400 Blood Gas Monitoring
System
(a) Model 6720, 1/4";
(b) Model 6725, 1/4" (bulk, non-sterile);
(c) Model 6730, 3/8";
(d) Model 6731, 3/8" with 6" tubing;
(e) Model 6735, 3/8" (bulk, non-sterile);
-10-
(f) Model 6740, 1/2";
(g) Model 6741, 1/2" with 6" tubing;
(h) Model 6745, 1/2" (bulk, non-sterile);
(i) Model 6750, Combo (containing Models 6730 & 6740);
(j) Model 6751, Combo with 6" tubing;
(k) Model 6770, Demo (containing Models 6730 & 6740).
Recall #Z-635/645-2.
CODE All lots.
MANUFACTURER CDI, 3M Health Care, Tustin, California.
RECALLED BY Manufacturer, by telephone beginning January 30, 1992,
followed by letter dated February 3, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY (a) 600 units; (b) 271 units; (c) 11,380 units; (d) 1,280
units; (e) 21,271 units; (e) 10,388 units; (f) 1,250 units;
(g) 15,712 units; (h) 24; (i) 1,715 units were distributed.
REASON The cell membranes are tearing, compromising the sterility of
the barrier and increasing the potential for air to enter the
extracorporeal circuit.
PRODUCT (a) Monoject Bone Marrow Biopsy/Aspiration Needle with luer
lock adapter, 8 gage x 4 inch, Catalog #8881-242088; (b)
Monoject Bone Marrow Biopsy/Aspiration Tray, Catalog
#8881-844024; (c) Monoject Bone Marrow Biopsy Tray with
Biopsy/Aspiration Needle, Catalog #8881-844081.
Recall #Z-656-2.
CODE Lot numbers: (a) 555924, 57765, 57908, 58607, 59051, 60170,
60171; (b) 59901, 55902; (c) 56528.
MANUFACTURER Creative Research & Manufacturing, Inc., Minnetonka, Minnesota.
RECALLED BY: Sherwood Medical Company, St. Louis, Missouri, by letter
February 10, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 8,980 needles; (b) 510 kits; (c) 450 kits were distributed.
REASON Nonmedical grade stainless steel was used in the manufacture
of the needles although product specifications require medical
grade stainless steel.
PRODUCT Concha Reservoir Bottle, a plastic bottle containing 1500 ml
of usable sterile water for inhalation, USP. Recall #Z-657-2.
CODE Catalog numbers: 381-50 (bottle sold separately) EXP 6/93 -
4/94; 385-20, 385-30, 385060, 385-70 (bottles sold with
conchapak) EXP 6/93 - 4/94.
MANUFACTURER Hudson Respiratory Care, Inc., Arlington Heights, Illinois.
RECALLED BY Hudson Respiratory Care, Inc. (Hudson RCI), Temecula,
California, by letters dated August 9, 1991. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Japan, Mexico, Canada.
QUANTITY 28,230 bottles were distributed.
REASON Improper equalization could occur if the product is not
properly punctured on the upper port.
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PRODUCT Rx catheter products for use in electrophysiology:
(a) Elecath - Braided Elethane TM Quad Pacing Probe Curve -
Cournand Type - Length - 110cm - Electrode Spacing - 5mm -
Size 6 F, Catalog No. 704-22256;
(b) Elecath - Braided Elethane TM Quad Pacing Probe Curve -
Cournand Type - Length - 110cm - Electrode Spacing - 1cm -
Size 6 F, Catalog No. 704-22216;
(c) Elecath - Braided Elethane TM Quad Pacing Probe Curve -
Damato Type - Length - 110cm - Electrode Spacing - 1cm - Size
6 F, Catalog No. 704-42216;
(d) Elecath - Braided Elethane TM Quad Pacing Probe Curve
- Josephson Type - Length - 110cm - Electrode Spacing - 5mm -
Size 6 F, Catalog No. 704-32256. Recall #Z-658/661-2.
CODE All control numbers of catalog numbers 704-22256, 704-22216,
704-42216, 704-32256.
MANUFACTURER Electro-Catheter Corporation, Rahway, New Jersey.
RECALLED BY Manufacturer, by letter August 1, 1991. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Germany, England.
QUANTITY 505 units were distributed.
REASON The tubing was cracking just proximal to the 7cm tip.
PRODUCT Isotac Screwdriver (hex tubes) used in orthopedic surgery to
secure hexhead screws into bone. The screwdrivers are
components of the following orthopedic surgical sets: Catalog
#013650 Endo Drill Guides; 013131 Endo System; 013581 Isotac
Sets. Recall #Z-663-2.
CODE Catalog #013582, lot numbers: ACUFEX L1091, ACUFEX L1191,
ACUFEX L1291.
MANUFACTURER Acufex Microsurgical, Inc., Mansfield, Massachusetts.
RECALLED BY Manufacturer, by visit November 7, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, France, Austria, Belgium, Germany, England, Sweden.
QUANTITY 100 units were distributed.
REASON Firm redrew the specifications and changed the tolerance of
the screwdriver head which makes it smaller than the Isotac
screw.
PRODUCT Three inch wheeled foot pieces for walkers:
(a) Model No. 7731; (b) Model No. 7733;
(c) Model No. 7708; (d) Model No. 7731PG;
(e) Model No. 7733PG; (f) Model No. 7708PG;
(g) Model No. 7731TB; (h) Model No. 7733TB;
(i) Model No. 7708TB. Recall #Z-664/672-2.
CODE Lot numbers: 891208 through 891229, 900102 through 900131,
900201 through 900228, 900301 through 900330, 900402 through
900420.
MANUFACTURER Guardian Products, Arleta, California.
RECALLED BY Manufacturer, by letter May 2, 1990. Firm-initiated recall
ongoing.
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DISTRIBUTION Nationwide and international.
QUANTITY 7,200 units were distributed.
REASON The plastic wheels were breaking causing the patient to fall.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Synchron *CX Multi Calibrator, Part #442600, used for
calibration of albumin, blood urea nitrogen (urea), calcium,
cholesterol, creatinine, glucose, inorganic phosphorus, total
protein, triglycerides, and uric acid. Recall #Z-564-2.
CODE Lot numbers M101222 and M101222A, both EXP 9/30/92.
MANUFACTURER Beckman Instruments, Inc., Carlsbad, California.
RECALLED BY Beckman Instruments, Inc., Brea, California, by letters of
September 25, 1991, October 10, 1991 and March 11, 1992, and
by memorandum September 24, 1991 to international
subsidiaries. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Unknown.
REASON The phosphorus concentration is variable which could is result
in inaccurate patient values.
PRODUCT Respiracult-Strep Deep-Bed Culture-Paddles, an in-vitro
diagnostic test kit for the detection and presumptive
identification of beta-hemolytic group A streptococci from
throat and nasopharyngeal sources. Recall #Z-615-2.
CODE Lot numbers: RK061 EXP 2/1/92, RM069 EXP 3/15/92.
MANUFACTURER Orion Diagnostica, Espoo, Finland.
RECALLED BY Medical Technology Corporation, Somerset, New Jersey, by
letter January 13, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,950 vials of lot RK061 and 5,950 vials of lot RM069 were
distributed.
REASON Hemolysis or premature deterioration causes the device not to
perform properly.
PRODUCT Beckman "Genesis" Software for Biomek 1000, all version 2.10
(or earlier versions) Software Diskettes, indicated for use
with the Beckman "Biomed 1000" Automated Laboratory
Workstation, indicated for liquid handling operations in
research and industrial laboratories, including pipetting,
plate washing, cell feeding, and plate reading.
Recall #Z-616-2.
CODE All version 2.10 (or earlier versions) software diskettes.
MANUFACTURER Beckman Instruments, Inc., Fullerton, California.
RECALLED BY Manufacturer, by letter dated September 23, 1991.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, Australia, Canada, France, Germany, Japan, Sweden,
and The United Kingdom.
QUANTITY 38 diskette sets were distributed.
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REASON The device contains an error which causes an unrecoverable
loss of data, lacks approval signature for version 2.10 change
record and the logging of optical density data for version
2.10 had not been reviewed prior to release.
PRODUCT Calibration Gas Cylinder labeled as 5% CO2, 21% 02, Balance
N2, manufactured for Marquette Electronics. Recall #Z-619-2.
CODE Lot numbers: 042209, 041939, 020150, 011269, 101929, 031469,
011289, 012589, 151589, 171249.
MANUFACTURER Scott Medical Products, Inc., Plumsteadville, Pennsylvania.
RECALLED BY Manufacturer, by FAX January 24, 1992, followed by letter
February 13, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Unknown.
QUANTITY 1,386 cans were distributed.
REASON Cylinders actually contains 4.7% CO2, 21% 02, and balance N2.
PRODUCT Virocult Specimen Swab. Recall #Z-620-2.
CODE Lot #91C05 EXP 3/92.
MANUFACTURER Medical Wire and Equipment Co., Ltd., Glasglow, Scotland.
RECALLED BY Medical Wire & Equipment Company, USA, Sparta, New Jersey, by
telephone in November 1991, followed by letter.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 12,000 units were distributed.
REASON The product failed to meet sterility claims.
PRODUCT Precise PGX-35W Skin Staplers. Recall #Z-621-2.
CODE SEPT 91 437, 438, 439, 440, 441; OCT 91 442, 443, 444, 445,
446, 447, 448.
MANUFACTURER 3M Edmuex, Juarez, Mexico.
RECALLED BY 3M Surgical Division, 3M Healthcare, 3m Company, St. Paul,
Minnesota, by letters dated February 21, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 20,000 skin staplers were distributed.
REASON The trigger of some staplers returns very slowly or not at all
after firing a staple.
PRODUCT Vision Improving Eyeglasses (aerobic pinhole glasses).
Recall #Z-655-2.
CODE Catalog 43717, all units.
MANUFACTURER Natural Vision International, Ltd., Manitowoc, Wisconsin.
RECALLED BY Hammacher Schlemmer & Company, Inc., Chicago, Illinois, by
letter November 26, 1991. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,550 pairs were distributed; firm estimates 7,700 pairs
remain on the market.
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REASON Some of the claims provided by the manufacturer of the "Vision
Improving Eyeglasses," which are contained in the materials
included with the product and some of which were reprinted in
the recalling firm's catalog, may not have adequate
substantiation.
MASS SEIZURES:
PRODUCT Apnea and Heart Rate Monitors (90-582-702).
FIRM Estrella Medical, Inc., Euless, Texas.
CHARGE Adulterated - The methods used in, and the facilities and
controls used for their manufacture, packing, and storage are
not in conformity with current good manufacturing practice
regulations. Misbranded - A pre-market notice or other
information, and medical device reporting information
respecting the devices was not provided as required by statute
and regulation.
FILED July 29, 1991 - U.S. District Court for the Northern District
of Texas, Fort Worth Division; Civil #CA4 91-0516-A,
FDC #66165.
SEIZED August 6, 1991 - devices valued at approximately $75,000
January 22, 1992 - Consent Decree for Destruction.
PROUCT Oxygen USP (92-609-471).
FIRM E.F. Silvey, Inc., Harriman, Tennessee.
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the manufacture, processing, packing, and
holding do not conform to and are not operated and
administered in conformity with current good manufacturing
practice regulations.
FILED April 6, 1992 - U.S. District Court for the Eastern District
of Tennessee, Northern Division; Civil #3-92-215, FDC #66382.
SEIZED April 8, 1992 - bulk oxygen in 2 tanks and 64 high pressure
cylinders, valued at approximately $17,000.
PRODUCT Oxygen USP (92-577-082).
FIRM Lessors Welding Supply, Burton, Michigan.
CHARGES Adulteration - The methods used in, and the facilities and
controls used for, the packaging and holding do not conform to
and are not operated and administered in conformity with
current good manufacturing practice regulations.
FILED March 24, 1992 - U.S. District Court for the Eastern District
of Michigan, Southern Division; Civil# 92CV40138, FDC #66369.
SEIZED April 15, 1992 - bulk oxygen and H, D, and E cylinders, valued
at approximately $2,000.
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END OF ENFORCEMENT REPORT FOR MAY 6, 1992. BLANK PAGES MAY FOLLOW.
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