CODE
"JUL 22, 1998".
MANUFACTURER
Quesos Puebla, Brooklyn, New York.
RECALLED BY
Manufacturer, by telephone on July 27, 1998. Completed recall
resulted from sample analysis and follow-up by the New York
Department of Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
Firm estimates none remains on the market.
REASON
Product is contaminated with Listeria monocytogenes.
PRODUCT
Queseria Zurita Spanish White Cheese, in foil wrap packages, 14
ounces. Recall #F-031-9.
CODE
May 30.
MANUFACTURER
Zurita Cheese, Brooklyn, New York.
RECALLED BY
Manufacturer, by visit on or about May 26, 1998, and by press
release issued by the New York State Department of Agriculture
and Markets (NYSDAM) on May 26, 1998. Completed recall resulted
from sample analysis and follow-up by NYSDAM.
DISTRIBUTION
New York.
QUANTITY
120 units were distributed.
REASON
Product is contaminated with Listeria monocytogenes.
CODE
1210411.
MANUFACTURER
Leslie Corporation, Paranaque, Manila, Phillippines.
RECALLED BY
Summit Import Corporation, New York, New York, by letter dated
September 8, 1997. Completed recall resulted from sample
analysis and follow-up by the New York State Department of
Agriculture and Markets.
DISTRIBUTION
North Carolina, Florida, New Jersey, New York, Maryland.
QUANTITY
40 cases were distributed.
REASON
Product contained undeclared colors certifiable as FD&C Yellow
No. 5 and FD&C Yellow No. 6.
CODE
Cases are coded 072798L through 091798L, retail packages are
coded G8Lxx where xx = 27 through 31, H8Lxx where xx = 01 through
31, and I8Lxx where xx = 01 through 17.
MANUFACTURER
The Pillsbury Company, Lithonia, Georgia.
RECALLED BY
The Pillsbury Company, Minneapolis, Minnesota, by electronic mail
on September 28, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
39,892 cases containing 12 10 or 12-ounce retail bags of the
crusts, or 6 of the 25 ounce boxes were distributed.
REASON
The products are unfit for food because colors migrated to the
crusts from the product label.
CODE
Lot number 8G01759.
MANUFACTURER
Ayerst-Wyeth Pharmaceuticals, Inc., Guayama, RQ.
RECALLED BY
Leiner Health Products, Madison, Wisconsin, by letter on
September 15, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
16,004 bottles were distributed.
REASON
Mislabeling - One bottle labeled by Leiner Health Products as
Premarin 1.25 mg tablets actually contained Buspar 10 mg tablets
(Buspirone HCL USP).
UPDATE Recall # D-006/009-9 (Inwood Labs) Propranolol HCl ER 60 mg capsules, lot 8A38 (1/99), which appeared in the November 4, 1998 Enforcement Report should read lot 8A038.
CODE
Lot #XI-110 EXP 9/98.
MANUFACTURER
3M Healthcare, Loughborough, UK.
RECALLED BY
Astra USA, Inc., Westborough, Massachusetts, by letter starting
the first week of October 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
91,704 units were distributed.
REASON
Product exceeds total degradation specification (stability
testing).
CODE
Units 07FM06232, 07FM06235.
MANUFACTURER
American Red Cross, Tucson, Arizona.
RECALLED BY
Manufacturer, by letter dated April 8, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Arizona.
QUANTITY
2 units were distributed.
REASON
Platelets were shipped at an unacceptable temperature.
PRODUCT
a) Red Blood Cells; b) Recovered Plasma for Further Manufacture.
Recall #B-097/098-9.
CODE
Unit #42T55014.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated March 18, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio and Massachusetts.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of
exposure to hepatitis.
PRODUCT
Red Blood Cells. Recall #B-099-9.
CODE
Unit #N37898.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY
Manufacturer, by letter dated July 10, 1997. Firm-initiated
recall complete.
DISTRIBUTION
Virginia.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor taking the drug Cytotec
(misoprostol).
PRODUCT
Platelets. Recall #B-100-9.
CODE
Unit #1501245.
MANUFACTURER
Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
RECALLED BY
Manufacturer, by telephone on July 27, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Kentucky.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor taking the drug Lodine
(etodolac).
PRODUCT
Platelets, Pheresis. Recall #B-101-9.
CODE
Unit #50P20560.
MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY
Manufacturer, by letter dated July 6, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product tested negative for the CMV, but was collected from
a donor who previously tested CMV positive.
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma.
Recall #B-102/104-9.
CODE
Unit numbers: a) 5024208, 5024226, 5024232; b) 5024232; c)
5024216, 5024226, 5024250, 5024256.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
BloodCare, doing business as Carter Blood Center, Bedford, Texas,
by letter dated April 28, 1998, and/or by fax on April 24, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Texas and Switzerland.
QUANTITY
a) 3 units; b) 1 unit; c) 4 units were distributed.
REASON
Blood products were collected from donors whose arm had not been
adequately prepared prior to venipuncture.
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-105/106-9.
CODE
Unit numbers: a) 18215-1277, 18215-1273, 18215-1029, 18215-1030,
18215-1322; b) 18215-1277, 18215-1273, 18215-1274.
MANUFACTURER
United Blood Services, Cheyenne, Wyoming.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October
24, 1997 or October 31, 1997, and by letter dated November 13,
1998. Firm-initiated recall complete.
DISTRIBUTION
Illinois, North Carolina, Wyoming.
QUANTITY
a) 5 units; b) 3 units were distributed.
REASON
Blood products were collected in a manner that compromised
the sterility of the units.
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-107/109-9.
CODE
Unit #V57551.
MANUFACTURER
Mississippi Valley Regional Blood Center, Davemport, Iowa.
RECALLED BY
Manufacturer, by letter dated March 11, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Louisiana, Virginia, California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood product was collected from a donor who within the previous
12 months had lived in a household with a mother who had
hepatitis.
PRODUCT
a) Red Blood Cells; b) Fresh frozen Plasma; c) Recovered Plasma.
Recall #B-111/113-9.
CODE
Unit numbers: a) 6164591; b) 4648686; c) 6164591.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
BloodCare, doing business as Carter BloodCare, Bedford, Texas, by
letter dated either June 12 or 15, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Texas and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of
hepatitis.
PRODUCT
Whole Blood. Recall #B-114-9.
CODE
Unit #5010352.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
BloodCare, doing business as Carter BloodCare, Bedford, Texas, by
letter dated August 17, 1998. Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had engaged in high
risk behavior.
PRODUCT
a) Red Blood cells; b) Platelets. Recall #B-117/118-9.
CODE
Unit #01GL02017.
MANUFACTURER
American Red Cross Blood Services, Syracuse, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by letter
dated November 18, 1997. Firm-initiated recall complete.
DISTRIBUTION
New York.
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.
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-119/120
-9.
CODE
Unit #01LW08212.
MANUFACTURER
American Red Cross Blood Services, Buffalo, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by
telephone on April 6, 1998, and by letter dated April 8, 1998.
Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were contaminated with coagulase negative
staphylococcus.
PRODUCT
Platelets, Pheresis. Recall #B-121-9.
CODE
Unit #01FP03682.
MANUFACTURER
American Red Cross Blood Services, Albany, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by
telephone on December 11, 1997, and by letter dated January 12,
1998. Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Platelets, Pheresis had a high white cell count.
CODE
Unit #18214-7380.
MANUFACTURER
United Blood Services, Cheyenne, Wyoming.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated October
24, 1997. Firm-initiated recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a unit of whole blood with an
extended collection time.
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced by
Filtration. Recall #B-125/126-9.
CODE
Unit Numbers: a) 12427-8445, 12427-8444, 12427-8443, 12427-8442,
12427-8441, 12427-8440, 12427-8439, 12427-8438, 12427-8435,
12427-8434, 12427-8433, 12427-8431, 12427-8427, 12427-8437;
b) 12427-8436.
MANUFACTURER
United Blood Services, Albuquerque, New Mexico.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on
February 12, 1998. Firm-initiated recall complete.
DISTRIBUTION
Arizona, New Mexico, Texas.
QUANTITY
a) 14 units; b) 1 unit.
REASON
Blood products were labeled with extended expiration dates.
RECALLS AND FIELD CORRECTIONS:
DEVICES -- CLASS II
Universal Clinical Workstation (UCW), Monitor Model 90385, a
generic display device with networking and data management
capabilities. Recall #Z-834-8.
CODE
All units shipped prior to 3/97. Serial numbers used by the firm
are not sequential.
MANUFACTURER
Spacelabs Medical, Redmond, Washington.
RECALLED BY
Manufacturer, by Product Service Notice (PSN) 076-0469-00 dated
September 16, 1996 and PSN 076-0541-00 dated February 7, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
3,328 monitors are affected by this field correction.
REASON
Base screws are too short which could allow the monitor to
dislodge from wall mounted base.
PRODUCT
Leksell GammaPlan (LGP) Version 4.01-4.11, software is designed
for use with the Leksell Gamma Knife. The Leksell GammaPlan is
intended to be used for planning the dosimetry of treatments in
stereotactic radiosurgery and stereotactic radiation therapy.
Recall #Z-118-9.
CODE
Leksell GammaPlan (LGP) Versions 4.01-4.11.
MANUFACTURER
Elekta AB, Stockholm, Sweden.
RECALLED BY
Elekta Instruments, Inc., Atlanta, Georgia, by technical alert
sent dated June 1997. Firm-initiated field correction
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
38 units were distributed.
REASON
An error in the plug command which caused the dose planning
software GammaPlan to give too long treatment times, meaning
that the patient receives a higher dose than prescribed.
PRODUCT
Leksell GammaPlan (LGP) Versions 3.0 and KULA used in conjunction
with Elekta's Gamma Knife. The Leksell GammaPlan is intended to
be used for planning the dosimetry of treatments in stereotactic
radiosurgery and stereotactic radiation therapy.
Recall #Z-120-9.
CODE
Leksell GammaPlan Version 3.0 and KULA. The KULA version is the
predecessor of the Leksell GammaPlan.
MANUFACTURER
Elekta AB, Stockholm, Sweden.
RECALLED BY
Elekta Instruments, Inc., Atlanta, Georgia, by product bulletin
dated July 1, 1996. Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
38 units were distributed.
REASON
A calculation error in the dose planning system may, under
unusual circumstances, result in the miscalculation of the
distance form the skull boundary to the intended target,
resulting in a dose lower than prescribed.
PRODUCT
Leksell Gamma Knife, Models U and B. The model U represents the
majority of the units in the United States. Model B is the newer
version of the Gamma Knife, used for the non-invasive treatment
of selected intracranial disorders. Recall #Z-121-9.
CODE
Models U and B.
MANUFACTURER
Elekta AB, Stockholm, Sweden.
RECALLED BY
Elekta Instruments, Inc., Atlanta, Georgia, by Technical Note
#006 dated November 1996. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
38 units were distributed.
REASON
Complaints involving lacerations of fingers and entrapment of an
elbow during use of the device.
PRODUCT
Biotrack Protime Reagent Cartridges CoaguChek Plus Prothrombin
Time (PT) Test Cartridges:
a) Biotrack Protime Reagent Cartridges, Catalog No. 473043;
b) CoaguChek Plus PT Test Cartridges, Catalog No. 473707.
Recall #Z-122/123-9.
CODE
a) All Lot Numbers which begin with P616 and P702;
b) All Lot Numbers which begin with P616 and P702.
MANUFACTURER
Boehringer Mannheim Corporation, Fremont, California.
RECALLED BY
Boehringer Mannheim Corporation, Indianapolis, Indiana, by
telephone in November 1997, and by letter dated July 1, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Australia, Canada, Chili, Germany, Japan,
Switzerland.
QUANTITY
9,427 boxes of CoaguChek plus and 4479 boxes of Coumatrak Protime
were distributed since November 20, 1996.
REASON
When used with the Protime Controls these cartridges give
results which are out of published range.
PRODUCT
Sunmark brand Heat Therapy Heating Pads:
a) Sunmark brand Dry Heat Therapy Heating Pad, Model No. 2000; b) Sunmark Brand Dry/Moist Heat Therapy Heating Pad, Model No. 2025; c) Sunmark Brand Dry/Moist Heat Therapy Heating Pad, Model No. 2050. Recall #Z-124/126-9.
CODE
All units.
MANUFACTURER
Square Fund Industrial Limited, Shenzhen, China.
RECALLED BY
Homedics, Inc., Keego Harbor, Michigan, by letter dated March 13,
1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 14,674 pads were distributed.
REASON
Scorching of the heating pads and overlying materials may occur
when the product is in use.
PRODUCT
Anesthesia Gas Sampling Elbow and Anesthesia Circuits
containing this elbow:
a) Gibeck Anesthesia Gas Sampling Elbow, Part No. 92001; b) Datex-Ohmeda brand ET ELBOW ADAPTER(X10) Anesthesia Circuit, Catalog No. 6027-0000-020,; c) Gibeck brand anesthesia circuits which contain the Gas Sampling Elbow, Part No. 92001. Recall #Z-141/143-9.
CODE
All lots produced prior to 10/27/97:
a) Part #92001; b) Lot No. M039034 c) Gibeck brand anesthesia circuits which contain the Gas Sampling Elbow, Part No. 92001, as follows: Catalog Number Lot Numbers 10311 M039005 130-0003-064 C042072 13005-230 M038708 13201-683 C042046 13300-951 C041902 13401-951 C042048 140-0000-371 C041815 140-0000-868 C041738 140-0002-296 C041743 140-0004-484 C041816 14111-BMK C041839 14211-951 C041817 16002-951 C041751 16003-BLS C041697 16003-951 C040029, C041996, C042007 16303-951 C041644 16013-951 C041755 16013-959 C041653 16203-951 C041864 16313-951 C041819 16401-951 C041814 16411-596 C041759 16411-798 C041999 16411-951 C041756 16412-BHS C041792 170022-951 C041761, C041798 170032-269 C041844 170032-798 C041695 170032-951 C041275, C041674, C041684, C041736, C041845, C041861, C041903 170032-BDB C041867 170032-BFB C041781 170032-BLL C041843 170132-475 C041763 170232-951 C041656, C041728, C041791, C041985 172032-951 C041824 173032-951 C041918 173132-951 C041767 174112-951 C041708, C041965 301-0002-769 C041826, C041862 301-0002-774 C041770 302-0000-230 C041796 302-0000-537 C041846 302-0000-701 C041888 302-0001-214 C041711 302-0001-342 C041680 302-0001-402 C041737, C041942 302-0001-702 C041869 302-0001-868 C041827 302-0002-495 C041712 302-0002-506 C041991 302-0002-775 C041847 302-0003-060 C041848 302-0003-502 C041724 302-0003-564 C041700 302-0003-692 C041731 302-0003-907 C041701 302-0003-919 C041799 302-0004-408 C041836 304-0002-123 C041746 304-0002-173 C041773 304-0002-673 C042107 304-0003-625 C041704 304-0004-234 C041930 305-0000-319 C041797 305-0001-824 C041957 MM15207-304 M038283.
MANUFACTURER
Gibeck, Inc., Indianapolis, Indiana.
RECALLED BY
Manufacturer, by letter dated June 12, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Nationwide, France, Germany, Slovenia.
QUANTITY
23,013 units were distributed.
REASON
The bend in the elbow was 99% occluded.
PRODUCT
Pharmacia brand Superblade Trephine (Surgical Blade Assembly),
single use only, used in corneal transplant surgery:
a) Model No. 15-0140-65; b) Model No. 15-0140-67; c) Model No. 15-0140-70; d) Model No. 15-0140-72; e) Model No. 15-0140-75; f) Model No. 15-0140-77; g) Model No. 15-0140-80; h) Model No. 15-0140-82; I) Model No. 15-0140-85; j) Model No. 15-0140-87; k) Model No. 15-0140-90; l) Model No. 15-0140-92; m) Model No. 15-0140-95. Recall #Z-158/170-9.
CODE
All blades distributed between 9/93 and 9/98.
MANUFACTURER
Pharmacia & Upjohn Groningen BV, Groningen, Netherlands.
RECALLED BY
Pharmacia & Upjohn Company, Kalamazoo, Michigan, by telephone
between October 2 and 30, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
13,050 blades were distributed between 9/93 and 9/98.
REASON
The blades may become dulled prior to use, due to failure of
proper fit in their protective packaging.
CODE
Software version 3.01.
MANUFACTURER
Elekta AB, Stockholm, Sweden.
RECALLED BY
Elekta Instruments, Inc., Atlanta, Georgia, by releasing a new
version of software in July 1998. Firm-initiated field
correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
38 units were distributed.
REASON
Instead of using the 50% line, the default dose setting was used
resulting in the administration of 10Gy rather than 22Gy
resulting in underdose.
PRODUCT
Model No. 1100 Calibration Solution Pack for the SenDx 100 Blood
Chemistry Analyzer, for in-vitro diagnostic use.
Recall #Z-127-9.
CODE
Lot numbers 51501 and 51525.
MANUFACTURER
SenDx Medical, Inc., Carlsbad, California.
RECALLED BY
Manufacturer, by telephone and by letter dated September 24,
1998. Firm-initiated field correction complete.
DISTRIBUTION
California, Idaho, Florida, Georgia, Indiana, Louisiana, New
Jersey, Ohio, Pennsylvania, Japan, Denmark.
QUANTITY
68 units were distributed.
REASON When used with the sensor cassette this calibration pack gives falsely elevated pCO2 values.
END OF ENFORCEMENT REPORT FOR NOVEMBER 11, 1998. BLANK PAGES MAY FOLLOW.