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.
October 27, 1999 99-
43
RECALLS AND FIELD CORRECTIONS: DRUGS --
CLASS I
________
PRODUCTS
a) Penicillin G Potassium for Injection, 20 Million Units, 100 mL
vial, Rx bactericidal for IM or IV use.
b) Cefuroxime Sodium, USP, Sterile, 1.5 grams, 20 mL vial, Rx
semi-synthetic broad spectrum cephalosporin antibiotic for IM or
IV use
c) Cefuroxime Sodium, USP, Sterile, 750 mg, 10 mL vial, Rx semi-
synthetic broad spectrum cephalosporin antibiotic for IM or IV
use.
d) Cefazolin Sodium, USP, Sterile, 1 gram, 10 mL vial, Rx semi-
synthetic cephalosporin for IM or IV use
e) Ampicillin Sodium, USP, Sterile, 250 mg, 6 mL vial, Rx
synthetic penicillin for IM or IV use
f) Ampicillin Sodium, USP, Sterile, 500 mg, 6 mL vial, Rx
synthetic penicillin for IM or IV use
g) Oxacillin Sodium for Injection, USP, 10 grams, 100 mL vial, Rx
penicillinase-resistant, acid resistant, semi-synthetic
penicillin. Recall #D-050/056-0.
CODE
a) Lot #9801015 (Control #8M12221) EXP 12/01 NDC 0209-8580-22
b) Lot #9806019 (Control #8E02475) EXP. 00 MA
c) Lot #9810030 (Control #8J02600) EXP 09/2000 NDC 0209-1132-22
d) Lot#9902058 (Control #9A12836) EXP 01/01 NDC 0209-0900-20
Lot #9902059 (Control #9A12837) EXP 01/01 NDC 0209-0900-20
Lot #9805020 (Control #8D02403) EXP 04/2000 NDC 0209-1000-42
e) Lot #9902054A (Control #9A12833) EXP 01 JA
Lot #9902054B (Control #9A22834) EXP 01/2002 NDC 0209-0100-22
f) Lot #9902053A (Control #9A12831) EXP 01 JA
Lot #9902053B (Control #9A22832) EXP 01/2002 NDC 0209-0150-22
g) Lot #9704019 (Control #7D01760) EXP 04/00 NDC 0209-8300-52
Note: All products are identified on the label by the Control
Number. The firm's lot number does not appear on the label.
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
Manufacturer, by letter dated July 7, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
The following amounts per lot were distributed:
Penicillin: Lot# 9801015 (Control No. 8M12221)
2,523 trays, 10 vials per tray
Cefuroxime Sodium: Lot# 9806019 (Control #8E02475)
3,512 trays, 10 vials per tray
Lot# 9810030 (Control #8J02600)
1,286 trays, 10 vials per tray
Cefazolin Sodium: Lot#9902058 (Control #9A12836)
4,661 trays, 25 vials per tray
Lot#9902059 (Control #9A12837)
5,124 trays, 25 vials per tray (note: 3 trays are on hand
at the firm's distribution center in Brewster, NY)
Lot# 9805020 (Control No. 8D02403) - 6,040 trays, 10
vials per tray
Ampicillin Sodium: Lot# 9902054A (Control No. 9A12833)
1,280 trays, 10 vials per tray
Lot# 9902054B (Control No. 9A22834) - 9,576 trays,
10 vials per tray (Note: this lot was shipped from
Marsam to their distribution center in Brewster, NY
and is on hand at that facility).
Lot# 9902053A (Control No. 9A12831) - 2,201trays,
10 vials per tray
Lot# 9902053B (Control No. 9A22832) - 8,910 trays,
10 vials per tray (note: 7,315 trays are on hand at
the firm's distribution center in Brewster, NY).
Oxacillin: Lot# 9704019 (Control No. 7D01760) - 445 trays,
10 vials per tray.
REASON
Microbial contamination revealed during initial sterility testing
(at release).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________
PRODUCTS
Nafcillin Sodium for Injection, USP, in 100 mL vial, Rx intended
for preparing IV admixtures only.
NDC #0209-7250-52. Recall #D-013-0.
CODE
Lot # 9711018 (Control # 7K02124), EXP 10/2000.
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
Manufacturer, by letter dated April 8, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
613 trays (10 vials per tray) were distributed.
REASON
Failure to meet particle size specification.
________
PRODUCTS
Various Rx drugs, some multiple potencies. Products were
packaged/labeled under various labels which included Marsam
Pharmaceuticals, Cherry Hill, NJ label, Schein Canada label,
Marsam Canada label (batches made in 1996), Schein
Pharmaceutical, Florham Park, NJ label, Apothecon label, VHA
label, and Agvar Chemical label as specified below:
Ampicillin Sodium, USP, Sterile, 10 gram vial
Ampicillin Sodium, USP, Sterile, 2 gram vial
Ampicillin Sodium, USP, Sterile, 1 gram vial
Ampicillin Sodium, USP, Sterile, 500mg vial
Ampicillin Sodium, USP, Sterile, 250 gram vial
Ampicillin Sodium, USP, Sterile, 125 gram vial
Cefaclor Capsules, USP, 250 mg
Cefaclor Capsules, USP, 500mg
Cefaclor for Oral Suspension, USP 125 mg
Cefaclor for Oral Suspension, USP 187 mg
Cefaclor for Oral Suspension, USP 250 mg
Cefaclor for Oral Suspension, USP 375 mg
Cefazolin Sodium, USP, Sterile, 20 gram
Cefazolin Sodium, USP, Sterile, 10 gram
Cefazolin Sodium, USP, Sterile, 1 gram
Cefazolin Sodium, USP, Sterile, 500 mg
Cerfuroxime Sodium, USP, Sterile, 7.5 grams
Cerfuroxime Sodium, USP, Sterile, 1.5 grams
Cerfuroxime Sodium, USP, Sterile, 750 mg
Isoflurane USP , 99.9 %, 100 and 250 mL bottles
Nafcillin Sodium for Injection, USP, 10 gram
Nafcillin Sodium for Injection, USP, 2 gram
Nafcillin Sodium for Injection, USP, 4 gram
Nafcillin Sodium for Injection, USP, 1 gram
Nafcillin Sodium for Injection, USP, 500 mg
Oxacillin Sodium for Injection, USP, 10 gram
Oxacillin Sodium for Injection, USP, 2 gram
Oxacillin Sodium for Injection, USP, 1 gram
Oxacillin Sodium for Injection, USP, 500 mg
Penicillin G Potassium for Injection, USP, 20 million units
Penicillin G Potassium for Injection, USP, 10 million units
Penicillin G Potassium for Injection, USP, 5 million units
Penicillin G Potassium for Injection, USP, 1 million units
Penicillin G Sodium for Injection, USP, 10 million units
Penicillin G sodium for Injection, USP, 5 million units
Penicillin G Sodium for Injection, USP, 1 million units.
Recall #D-014/049-0.
CODE
All lots with expiration date.
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
Manufacturer, by letters dated July 15, 19, 21 1999, and August
17, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
Undetermined.
REASON
Current good manufacturing practice deviations.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCTS
Nafcillin Sodium for Injection, Rx semi-synthetic penicillin
derived from the penicillin nucleus for IM or IV administration:
a) Nafcillin Sodium for Injection, USP, 500 mg, 6 mL vial,
Control/Lot No. 7L02199
b) Nafcillin Sodium for Injection, USP, 1g, 20 and 100 mL vials;
c) Nafcillin Sodium for Injection, USP, 2g, 20 and 100 mL vials;
d) Nafcillin Sodium for Injection, USP,10g, 100 mL vial, 4 lot
numbers
e) Ampicillin Sodium, USP Sterile, 1g, 10mL vial, Rx synthetic
penicillin indicated for treatment of moderately severe and
severe infections caused by susceptible strains of numerous
(mostly gram-positive, but also specific gram-negative) organisms
for IM or IV administration;
f) Cefazolin Sodium, USP, Sterile, 1 gram, 10 mL vial, Rx a semi-
synthetic cephalosporin for IM or IV administration and is
indicated in the treatment of serious infections.
Recall #D-005/010-0.
CODE
Nafcillin Sodium for Injection:
Lot # 9712026 (Control # 7L02199), EXP 11/2000- NDC 0209-6900-22
Lot # 9701040 (Control # 7A01645), EXP 01/2000-NDC 0209-6950-22
Lot # 9710018 (Control # 7J02067), EXP 09/2000- NDC 0209-6950-22
Lot # 9712024 (Control # 7L02191), EXP 11/2000- NDC 0209-6950-22
Lot # 9711030 (Control # 7K02143), EXP 10/2000- NDC 0209-6950-22
Lot # 9710049 (Control # 7J02100), EXP 09/2000- NDC 0209-7000-42
Lot # 9702001 (Control # 7B01647), EXP 02/2000- NDC 0209-7100-22
Lot # 9702002 (Control # 7B01648), EXP 02/2000- NDC 0209-7100-22
Lot # 9802031 (Control # 8A12261), EXP 01/01- NDC 0209-7100-22
Lot # 9711015 (Control # 7K02121), EXP 10/2000- NDC 0209-7150-42
Lot # 9701037 (Control # 7A01643), EXP 01/2000- NDC 0209-7250-52
Lot # 9701038 (Control # 7A01644), EXP 01/2000- NDC 0209-7250-52
Lot # 9703050 (Control # 7C01722), EXP 03/2000- NDC 0209-7250-52
Lot # 9711019 (Control # 7K02125), EXP 10/2000- NDC 0209-7250-52.
Ampicillin Sodium:
Lot #9809031 (Control #8H12564) EXP 08/01- NDC 0209-0250-22; Lot
#9807019 (Control #8F02494) EXP 00 JN- no NDC number
Lot #9806017 (Control #8E02493) EXP 00 MA- no NDC number
Cefazolin Sodium:
Lot #9806023 (Control #8E02431) EXP 05/2000 -
NDC 0209-0900-24
Lot #9705027 (Control #7E91814) EXP 05/99- NDC 0209-1000-42
(Note: the Control Number identifies All products on the label.
The firm's lot number does not appear on the label).
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
Manufacturer, by letter sent on June 6, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
(a-d) Nationwide; e) Canada; f) Nationwide.
QUANTITY
The following amounts of Nafcillin Sodium for Injection, USP (per
lot) were distributed:
Lot # 9712026- 1,981 trays, 10 vials per tray
Lot # 9701040- 3,268 trays, 10 vials per tray
Lot # 9710018- 2,100 trays, 10 vials per tray
Lot # 9712024- 2,184 trays, 10 vials per tray
Lot # 9711030- 2,193 trays, 10 vials per tray
Lot # 9710049- 951 trays, 10 vials per tray
Lot # 9702001- 1,051 trays, 10 vials per tray
Lot # 9702002- 2,585 trays, 10 vials per tray
Lot # 9802031- 2,814 trays, 10 vials per tray
Lot # 9711015- 1,055 trays, 10 vials per tray
Lot # 9701037- 585 trays, 10 vials per tray
Lot # 9701038- 573 trays, 10 vials per tray
Lot # 9703050- 475 trays, 10 vials per tray
Lot # 9711019- 602 trays, 10 vials per tray
The following amounts of Sterile Ampicillin Sodium, USP (per lot)
were distributed:
Lot # 9809031- 5,093 trays, 10 vials per tray
Lot # 9807019- 6,264 trays, 10 vials per tray
Lot # 9806017- 6,000 trays, 10 vials per tray
The following amounts of Sterile Cefazolin Sodium, USP (per lot)
were distributed to consignees:
Lot # 9806023- 4,846 trays, 25 vials per tray **Note: this lot
was distributed to Schein Pharm., Brewster, NY only. Not yet
distributed to customers.
Lot # 9705027- 2,299 trays, 10 vials per tray.
REASON
Unapproved (ANDA) raw material assay calculations (averaging).
________
PRODUCTS
Sterile Cefazolin Sodium, USP, sterile, Rx semi-synthetic
cephalosporin for IM or IV administration and is indicated in the
treatment of serious infections:
a) 1 gram in 10 mL vial; b) 10 gram, in 100 ml vial.
Recall #D-011/012-0.
CODE
a) Lot # 9706054 (Control #7F91884) EXP 06/99,
NDC 0209-0900-24; b) Lot #9705035 (Control # 7E91833)
EXP 05/99, NDC 0209-1100-52. (Note: the Control Number
identifies All products on the label. The firm's lot Number does
not appear on the label).
MANUFACTURER
Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY
Manufacturer, by letter dated May 3, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
a) Nationwide; b) Massachusetts.
QUANTITY
a) 4,878 trays (25 vials per tray); b) 1,248 (10 vials per tray)
were distributed.
REASON
Failure to meet pH specification.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
Platelets. Recall #B-001-0.
CODE
FDA, Center for Biologics Evaluation and Research, Contact Office
of Compliance (301) 827-6220 for individual unit numbers recalled
MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY
Manufacturer, by fax dated January 5, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Texas.
QUANTITY
66 units were distributed.
REASON
Blood products were manufactured from whole blood that had been
stored at unacceptable temperatures.
________
PRODUCTS
a) Red Blood Cells; b) Platelets. Recall #B-002/003-0.
CODE
Unit #5110466.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
BloodCare, Dallas, Texas, by letters dated January 25, 1999, and
March 10, 1999, and by telephone on September 14, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported travel
outside of the United States.
________
PRODUCTS
Red Blood Cells. Recall #B-004-0.
CODE
Unit #49W24415.
MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY
Manufacturer, by letters dated June 16, 1999 and September 9,
1999. Firm-initiated recall complete.
DISTRIBUTION
Oklahoma.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported having
lived in an area designated as endemic for malaria.
________
PRODUCTS
a) Red Blood Cells; b) Platelets. Recall #B-005/006-0.
CODE
Unit #30GG38186.
MANUFACTURER
American National Red Cross, Ashley, Pennsylvania.
RECALLED BY
Manufacturer, by letters dated June 30, 1998, and December 4,
1998, and by telephone on June 25, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Pennsylvania and Massachusetts.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCTS
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
Recall #B-007/009-0.
CODE
Unit #30GG59449.
MANUFACTURER
American National Red Cross, Ashley, Pennsylvania.
RECALLED BY
Manufacturer, by letter dated September 3, 1998, and by telephone
on August 28, 1998. Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug
Lupron.
________
PRODUCTS
a) Red Blood Cells, Irradiated; b) Whole Blood, Irradiated.
Recall #B-013/014-0.
CODE
Unit Numbers: a) 0499861; b) 0499840.
MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, Texas.
RECALLED BY
Manufacturer, by letter dated March 2, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were out of controlled storage temperatures for an
undocumented length of time.
________
PRODUCTS
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced.
Recall #B-015/016-0.
CODE
Unit Numbers: a) 21FL34345, 21FL34367, 21GC58777, 21KK08098;
b) 21GC58868, 21GC58968, 21KG17209, 21KH18300, 21KH18318,
21KH18320.
MANUFACTURER
American Red Cross, Portland, Oregon.
RECALLED BY
Manufacturer, by telephone on May 27, 1999, and June 7, 1999, and
by letters on June 4, 18, 1999, July 16 or 29, 1999. Firm-
initiated recall complete.
DISTRIBUTION
Oregon and California.
QUANTITY
a) 4 units; b) 6 units were distributed.
REASON
Blood products were exposed to unacceptable shipping
temperatures.
________
PRODUCTS
a) Red Blood Cells; b) Cryoprecipitated AHF.
Recall #B-018/019-0.
CODE
a) 30GE08879 and 30GS09969; b) 30GE08879.
MANUFACTURER
American National Red Cross, Ashley, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on March 12, 1998, and by letter dated
March 16, 1998. Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania and Massachusetts.
QUANTITY
a) 2 units; b) 1 unit was distributed.
REASON
Blood products were collected from a donor whose body temperature
had not been recorded or which was identified for confidential
exclusion.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II
________
PRODUCTS
ACS: Centaur TROPONIN I IMMUNOASSAY (cTnI), For the quantitative
determination of cardiac troponin I in serum or heparinized
plasma and as an aid in the diagnosis of acute myocardial
infarction using the Chiron Diagnostics ACS: Centaur
Chemiluminescence System, For In-Vitro Diagnostic use. Recall
#Z-1263-9.
CODE
Lot 32 used in Kits with lot numbers:
Catalog No. 116993 100 Test Kit - Lot7409132
Catalog No. 116994 500 Test Kit - Lot 7409232 and 7464132.
MANUFACTURER
Bayer Diagnostics, E. Walpole, Massachusetts.
RECALLED BY
Manufacturer, by telephone on July 27, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
131 units were distributed.
REASON
Controls and patient samples were recovering higher results than
expected range.
________
PRODUCTS
Drill Guide. Recall #Z-017-0.
CODE
Part #388.02 lots A4GH708 and A4GB685.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by letter on March 4, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
52 units were distributed.
REASON
The cannulated center of the drill guide may not allow the drill
bit to pass through.
________
PRODUCTS
Blunt Side Opening Screw. Recall #Z-018-0.
CODE
Part number CD948.001, Lot A4FK782.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by letter on March 4, 1998.
Firm-initiated recall complete.
DISTRIBUTION
California, Florida, Georgia, Pennsylvania.
QUANTITY
15 units were distributed.
REASON
The screws from the production lot were manufactured at greater
length than specified.
________
PRODUCTS
Reaming Rods with Offset, Straight and Smooth Tips and Medullary
Tube: part numbers a) 351.71S; b) 351.76S;
c) 355.041S; d) 355.01S. Recall #Z-019/022-0.
CODE
Lot Numbers: a) A3IO738, A3IP115, A3JQ213, A3JS141;
b) A3IQ839, A3IQ842, A3JT680; c) A3JK922, A3II682, A3JQ545,
A3JV989, A3JQ546; d). XVC2608 and XVC2609.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by letter sent on March 3,
1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
3,915 units were distributed.
REASON
In some sterile packages, the sterility may be compromised.
________
PRODUCTS
a) Orion Tracheostomy Care Kit with 14-16 Fr Catheter; b)
TRACHEOSTOMY CARE KIT; sterile, single patient use trays; reorder
#3017. Recall #Z-024/025-0.
CODE
a) Item #AH3018, Lot S9258; b) Item #3017, Lot S9241.
MANUFACTURER
Orion Life Systems, Inc., Wheeling, Illinois (trays);
Jiang Su Jin Hong Corporation, Jintan City, Jiangsu, China
(gauze).
RECALLED BY
Orion Life Systems, Inc., Wheeling, Illinois, by telephone on
September 14, 1999, followed by fax. Firm-initiated recall
ongoing.
DISTRIBUTION
New York, Tennessee, Wisconsin, Florida, Pennsylvania.
QUANTITY
3,040 kits were distributed.
REASON
Gauze may be contaminated with ETO resistant mold.
________
PRODUCTS
Nucletron Plato External Beam Planning Radiation Therapy Software
V2.1.2 and MLC/Shape Software Module V2.3
Recall #Z-038-0.
CODE
Plato RTS software version V2.1.2 used with software module
MLC/Shape version V2.3.
MANUFACTURER
Nucletron BV, The Netherlands.
RECALLED BY
Nucletron Corporation, Columbia, Maryland, by letter and customer
information bulletin sent on August 10, 1999. Firm-initiated
field correction ongoing.
DISTRIBUTION
Ohio and Mexico.
QUANTITY
31 copies of software were distributed.
REASON
Coordinates for radiation beam used in therapy are mislabeled in
software.
________
PRODUCTS
Plato Brachytherapy Treatment Planning System.
Recall #Z-039-0.
CODE
Plato BPS Software Version 13.2 and higher.
MANUFACTURER
Nucletron BV, The Netherlands.
RECALLED BY
Nucletron Corporation, Columbia, Maryland, by letter on June 15,
1999. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
100 copies of software were distributed.
REASON
Software implementation error.
________
PRODUCTS
Oxygen Pressure Regulator, Models: 3125R1GREEN, 3125R2GREEN,
8725R2BLACK, 51B2215R2, 3125R2SILVER, 8700R1GREEN, 3125L1GREEN,
51B2215L1, 3125L1GREEN, 51B2225LD1 and 51B2225L1,L106-260, L270-
220/240,L370-220-A, -B, -G, -GL
and -R. Recall #Z-041/059-0.
CODE
Serial numbers apply TO ALL MODEL NUMBERS:
609478 THROUGH 629904
638835 THROUGH 656842
666805 THROUGH 667644.
MANUFACTURER
Inovo, Inc., Naples, Florida.
RECALLED BY
Manufacturer, by letter faxed on September 3 and 13, 1999. Firm-
initiated recall ongoing.
DISTRIBUTION
Illinois, California, Wisconsin, Utah, Arkansas, Minnesota,
Indiana, Texas, Washington state, Tennessee, Pennsylvania,
Missouri, Florida.
QUANTITY
4,856 regulators were distributed.
REASON
Faulty DISS fittings causing inadequate flow.
________
PRODUCTS
Bacterial/Viral Filters, used to filter air/gas on mechanical
ventilators and anesthesia gas machines to provide an added means
of cross-contamination protection:
a) Bacterial/Viral Filters, Catalogue No. 1605
b) Bacterial/Viral Filters, Catalogue No. 7178.
Recall #Z-062/063-0.
CODE
a) Lot Numbers: 1-22910, 3-21910, 4-21910, and 3-29910 (for
single patient use);
b) Lot Numbers: 2-03910 and 3-30910 (intended only for further
manufacturing).
MANUFACTURER
Hudson Respiratory Care, Inc., Temecula, California.
RECALLED BY
Manufacturer, by fax on July 27, 1999, and by letter on August 3,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Japan, Canada, Turkey.
QUANTITY
10,100 filters were distributed.
REASON
The filters were manufactured by ultrasonic welders that were
operating out of a state-of-control causing some over-welding
conditions to occur, compromising the filterís efficiency.
______
UPDATE
Stratus Cardiac Troponin I Fluorometric Enzyme Immunoassay,
Recall #Z-1257/1258-9, recalled by Dade Behring, Inc., which
appeared in the September 29, 1999 Enforcement Report should
read: REASON: Product may produce false
positive and false negative test results.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCTS
UV Absorbing Posterior Chamber Intraocular Lens:
a) Model MC20BA; b) MC60CM. Recall #Z-007/008-0.
CODE
60 lenses identified by a unique 9 digit serial number.
MANUFACTURER
Alcon Surgical, Inc., Huntington, West Virginia.
RECALLED BY
Alcon Japan, Ltd., Tokyo, Japan, by telephone or visit August 17,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Japan.
QUANTITY
60 lenses.
REASON
Mislabeling of registration number required for distribution of
product in Japan. Label does not include information necessary
for proper use of the product.
________
PRODUCTS
VIA ABG & Chemistry Cal Kit, an accessory used to calibrate the
VIA Blood Chemistry Monitoring System prior to patient attachment
and during monitoring of patient.
Recall #Z-028-0.
CODE
Catalog Number: ABG2, Lot Number: 9905182
MANUFACTURER
VIA Medical Corporation, San Diego, California.
RECALLED BY
Manufacturer, by letter dated June 21, 1999. Firm-initiated
recall complete.
DISTRIBUTION
California, Iowa, Illinois, Missouri, New Jersey, Pennsylvania,
Texas.
QUANTITY
880 kits were distributed.
REASON
An inappropriate calibration reference number was assigned to the
lot of kits, which could affect the measurement of the pH
parameter.
________
PRODUCTS
Radiographic Film Cassettes with Intensifying Screens for
Mammography:
a) MIN-R 2 Cassette with MIN-R Screen, Catalog Nos. 7087984 and
1821149 (18 X 24 cm);
b) MIN-R 2 Cassette with MIN-R Screen, Catalog Nos. 7091614 and
8410078 (24 X 30 cm);
c) MIN-R 2 Cassette with MIN-R 2000 Screen, Catalog Nos. 8104101
and 8928392 (18 X 24 cm);
d) MIN-R 2 Cassette with MIN-R 2000 Screen, Catalog No. 8999492
(24 X 30 cm);
e) MIN-R 2 Cassette with MIN-R 2190 Screen, Catalog Nos. 1260579
and 1650605 (18 X 24 cm);
f) MIN-R 2 Cassette with MIN-R 2190 Screen, Catalog Nos. 8910853
and 8851651 (24 X 30 cm). Recall #Z-029/034-0.
CODE
Case label: 139YY through 214YY.
MANUFACTURER
Eastman Kodak Company, Rochester, New York.
RECALLED BY
Manufacturer, by letter dated August 10, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
7,105 cassettes/screen systems were distributed.
REASON
The above-referenced cassettes potentially cause a small density
variation of approximately 0.3 overall density between
mammography films due to a change in supply of a small plastic
strip that keeps the cassette foam in place.
________
PRODUCTS
Reference Electrode Disposable Membrane Caps, intended for use
with the IL 1600 Series Blood Gas Analyzer.
Recall #Z-035-0.
CODE
Part Number: 70987-00, Lot Numbers: 81147 EXP 11/30/99
81250 EXP 12/13/99; 90101 EXP 1/31/00
I90102 EXP 1/20/00; I90103 EXP 1/31/00
I90104 EXP 1/13/00; I90205 EXP 2/28/00.
MANUFACTURER
Instrumentation Laboratory Company, Milan, Italy.
RECALLED BY
Instrumentation Laboratory Company, Lexington, Massachusetts, by
letter on September 10, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,425 boxes were distributed.
REASON
Mold contamination underneath membrane may cause stability
issues.
________
PRODUCTS
Siemens Accessory Set TCPO2+TCPCPO2 Probe, intended to
continuously monitor noninvasive trending of transcutaneous
carbon dioxide partial pressure in any patient population and to
monitor oxygen in the neonatal population when the patient is not
under gas anesthesia. Recall #Z-036-0.
CODE
Part #45 27 347 EH418, Kit Lot #R006.
MANUFACTURER
Radiometer Medical A/S, Copenhagen, Denmark.
Sticker labeled by: Siemens-Elema AB.
RECALLED BY
Siemens Medical Systems, Inc., Danvers, Massachusetts, by letter
dated July 23, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
International.
QUANTITY
17 kits were distributed.
REASON
Mislabeled -tcpO2 membrane kits labeled as tcpO2/tcpCO2 membrane
kits.
________
PRODUCTS
Total B-hCG Controls, for in-vitro diagnostic use.
Recall #Z-037-0.
CODE
List #9C21-10; Lot #53784Q100 EXP 12/23/99.
MANUFACTURER
Abbott Health Products, Inc., Barceloneta, Puerto Rico.
RECALLED BY
Manufacturer, by letter dated September 24, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
3,445 kits were distributed.
REASON
Control values are greater than the package insert ranges with
AxSYM or IMx systems.
________
PRODUCTS
FreshLook DuraSoft Phemfilcon A 45%, water 55% Toric Contact
Lenses for Astigmatism with Handling Tint; individually packaged
sterile contact lenses for disposable or frequent replacement
programs. Recall #Z-040-9.
CODE
Lot 081513 EXP 02/01 and 081514 EXP 02/01.
MANUFACTURER
Wesley Jessen Corporation, Des Plaines, Illinois.
RECALLED BY
Manufacturer, by letter dated September 30, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
873 lenses were distributed.
REASON
Lenses were labeled with an axis of 90 degrees when they actually
have an axis of 180 degrees.
________
PRODUCTS
Jupiter PTA Balloon Catheters: a) Catalog #436502S;
b) Catalog #436452S. Recall #Z-060/061-0.
CODE
Lot Numbers: a) A0699798; b) A0699797.
MANUFACTURER
Cordis Corporation, Miami Lakes, Florida.
RECALLED BY
Manufacturer, by letter faxed on September 16, 1999, followed by
visit. Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Michigan, Illinois, Mississippi, Iowa, District of
Columbia.
QUANTITY
27 units were distributed.
REASON
The outer carton was mislabeled with incorrect dimensions on side
panel.
________
PRODUCTS
Nikon Children's Eyewear Frames in various colors, Model KD5303.
Recall #Z-072-0.
CODE
Lot #N16134.
MANUFACTURER
Nikon Optical Company, Ltd., Tokyo, Japan.
RECALLED BY
Nikon, Inc., Melville, New York, by telephone or visit in March
1999, or by mail on March 18, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
198 units were distributed.
REASON
The rubberized end of the earpiece may separate from the frame
exposing the metal support rod that runs through the earpiece.
END OF ENFORCEMENT REPORT FOR OCTOBER 27, 1999.
####
![[FDA HOME PAGE]](https://webarchive.library.unt.edu/eot2008/20081007040130im_/http://www.fda.gov/icon/iconhome.gif)