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PRODUCT
Pocketsnacks, Pumpkin Faces Chocolate Filled, in 6 ounce plastic
bags. Recall #F-064-9.
CODE
None.
MANUFACTURER
Bitterman Family Confections, Kansas City, Missouri
(repacker).
RECALLED BY
Repacker, by press release and by letter October 30, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
253 dozen packages were distributed.
REASON
Product contains undeclared peanuts.
________
PRODUCT
Peony Mark brand Sweetened Waterchestnut Candy, in 6 ounce
flexible plastic bags. Recall #F-065-9.
CODE
None.
MANUFACTURER
Guangdong Zhongshan Julong Fruit Products and Foodstuff Fty.,
Guangdong, China (possible manufacturer/packer).
RECALLED BY
Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter dated
October 7, 1997. Completed recall resulted from sample analysis
and follow-up by the New York State Department of Agriculture and
Markets.
DISTRIBUTION
New York, New Jersey, Virginia.
QUANTITY
Approximately 108 cases (50 packages per case) were
distributed.
REASON
PRODUCT
contained undeclared
sulfites.
________
PRODUCT
Refrigerated Soup Concentrates in pouches: a) Tomato Florentine - Stockpot, 10 oz. & 3 lb., Sysco 3 lb. b) Tortellini Vegetable - Stockpot & Sysco, both 3 lb. c) Ravioli Tomato Parmesan - Stockpot & Sysco, both 3 lb. d) Pasta Fagioli - Stockpot, 10 oz. & 3 lb. e) Stroganoff Noodle - Stockpot, 3 lb. f) M.R.S. Turkey Flavored Vegetable Soup Base Without Meat, 3 lb. Recall #F-066/071-9.
CODE
All codes with "Best Used Before or Freeze By:" 03/13/99 or
earlier.
MANUFACTURER
Stockpot Soups, Inc., Redmond, Washington.
RECALLED BY
Manufacturer, by letter faxed on October 17, 1998. A press
release also issued on October 17, 1998. Firm-initiated field
correction (relabeling) complete.
DISTRIBUTION
Nationwide.
QUANTITY
PRODUCT Size Distributed Pasta Fagioli 10 oz. 257 Pasta Fagioli - Stockpot 3 lb. 1536 Tomato Florentine 10 oz. 500 Tomato Florentine - Stockpot 3 lb. 1011 Tomato Florentine - Sysco 3 lb. 527 Stroganoff Noodle -Stockpot 3 lb. 148 Ravioli Tomato Parmesan -Stockpot 3 lb. 824 Ravioli Tomato Parmesan - Sysco 3 lb. 1249 Tortellini Vegetable - Stockpot 3 lb. 2839 Tortellini Vegetable - Sysco 3 lb. 1309 M.R.S. Turkey Noodle w/o Meat 3 lb. 1273
REASON
Products contained undeclared egg ingredients.
PRODUCT
Soft Cake, ready to eat, in 12 ounce round plastic tray.
Recall #F-042-9.
CODE
None.
MANUFACTURER
Kwong Wah Cake Company, Inc., New York, New York.
RECALLED BY
Manufacturer, by telephone, by posting a placard by the cash
register for the cash and carry customers, and by letter on or
about August 6, 1998. Completed recall resulted from sample
analysis and follow-up by the New York State Department of
Agriculture and Markets.
DISTRIBUTION
New York and Virginia.
QUANTITY
Undetermined.
REASON
The product's label did not declare the presence of Yellow No. 5,
Blue No. 1, and Red No. 40; failed to declare an individual fat
and/or oil ingredient by its specific name; failed to declare
flavorings used as "natural" or "artificial"; and failed to
conspicuously list the name and place of business of the
manufacturer, packer, or distributor.
________
PRODUCT
Miochol E Intraocular Solution 1:100 with electrolyte diluent
(Acetylcholine Chloride), in 20 mg/2mL vials, used to obtain
miosis of the iris in seconds after delivery of the lens in
cataract surgery, in penetrating keratoplasty, iridectomy and
other anterior segment surgery where rapid miosis may be
required. NDC #58768-773-52. Recall #D-023-9.
CODE
Lot #V2333 EXP 4/99.
MANUFACTURER
OMJ Pharmaceuticals, San German, Puerto Rico (manufacturer of the
finished drug product and an approved testing facility).
RECALLED BY
CIBA Ophthalmics (CVO), Duluth, Georgia, by letter dated
September 23, 1998, followed by telephone. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
Undetermined.
REASON
Low pH.
PRODUCT
Extra Strength Enteric Coated Aspirin, 500 mg, in bottles of 60,
OTC pain reliever, under the following labels: Walmart, CVS,
Discount Drug Mart, Medicine Shop, Fedco, Leader Drug, Brooks,
Bindley Drug, and Family Independent. Recall #D-022-9.
CODE
Lot Numbers: 7061676, 7061677, 7062058, 7062103, 7063658,
7072722, 7073290, 7073293, 7073316, 7073317, 7073318, 7073327,
7073328, 7073329, 7073436, 7083652, 7083653, 7083745, 7083746,
7083890, 7084260, 7084269, 7095298, 7095394, 7095414, 7095415,
7105971, 7117162, 7117431, 7117432, 7117432, 7128944, 8031676.
MANUFACTURER
Time Caps, Inc., Farmingdale, New York (contract
manufacturer).
RECALLED BY
Granutec, Inc., Wilson, North Carolina, by telephone on April 14,
1998, and by letter faxed and mailed on April 16, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
891,281 bottles were distributed.
REASON
Failure to meet dissolution specifications.
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-158/159-9.
CODE
Unit #6F9600.
MANUFACTURER
Puget Sound Blood Center, Seattle, Washington.
RECALLED BY
Manufacturer, by letter dated June 24, 1998, or by fax dated June
26, 1998. Firm-initiated recall complete.
DISTRIBUTION
Tennessee and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who was taking the
drug Tegison.
________
PRODUCT
Red Blood Cells. Recall #B-166-9.
CODE
Unit #61737.
MANUFACTURER
Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY
Manufacturer, by letter dated July 15, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Oregon.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Source Plasma. Recall #B-186-9.
CODE
Unit #0460168384.
MANUFACTURER
NABI BioMedical Center, Dallas, Texas.
RECALLED BY
NABI, Boca Raton, Florida, by fax on January 7, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Germany.
QUANTITY
1 unit was distributed.
REASON
Blood products tested negative for HBsAg, but were collected from
a donor who previously tested reactive for HBsAg.
________
PRODUCT
Red Blood Cells. Recall #B-189-9.
CODE
Unit #49FJ66797.
MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY
Manufacturer, by letter dated October 5, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-190-9.
CODE
Unit #049GQ04796.
MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY
Manufacturer, by letter dated October 1, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit 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) Platelets; c) Recovered Plasma.
Recall #B-192/194-9.
CODE
Unit numbers: a) H21106, H23129; b) H21106; c) H21106,
H23129.
MANUFACTURER
Regional Health Resource Center, Urbana, Illinois.
RECALLED BY
Manufacturer, by letter or fax dated October 28, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Illinois, Texas, California.
QUANTITY
a) 2 units; b) 1 unit; c) 2 units were distributed.
REASON
Blood products were collected from a donor with a history of
cancer.
________
PRODUCT
Source Plasma. Recall #B-195-9.
CODE
Unit #00882378.
MANUFACTURER
NABI BioMedical Center, San Antonio, Texas.
RECALLED BY
NABI, Boca Raton, Florida, by letter dated July 30, 1998.
Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose history screening
was not performed.
________
PRODUCT
Source Plasma. Recall #B-196-8.
CODE
Unit #7030041125.
MANUFACTURER
NABI BioMedical Center, San Antonio, Texas.
RECALLED BY
NABI, Boca Raton, Florida, by letter dated July 24, 1998.
Firm-initiated recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose donor history
screening was not performed.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-197/199-9.
CODE
Unit #H31245.
MANUFACTURER
Regional Health Resources Center, Community Blood Services of
Illinois, Urbana, Illinois.
RECALLED BY
Manufacturer, by telephone on September 30, 1998, and by letter
dated October 14, 1998,or by fax on September 29, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Illinois, Texas, California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug
Acyclovir.
________
PRODUCT
Red Blood Cells. Recall #B-200-9.
CODE
Unit #16LL35643.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by telephone on September 18, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product had an unacceptable hematocrit.
________
PRODUCT
Platelets. Recall #B-201-9.
CODE
Unit #50FH02833.
MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY
Manufacturer, by telephone on July 16, 1998, and by letter dated
July 21, 1998. Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was not quarantined after receiving information
concerning post donation illness.
________
PRODUCT
Red Blood Cells. Recall #B-212-9.
CODE
Unit numbers: 01GL14727, 01GL14754, 01GN14243, 01GN14213
MANUFACTURER
American Red Cross Blood Services, Syracuse, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by
telephone on January 26, 1998. Firm-initiated recall
complete.
DISTRIBUTION
New York.
QUANTITY
4 units were distributed.
REASON
Four units of Platelets, implicated in a transfusion reaction,
were found to be contaminated with Staphylococcus Aureus.
Corresponding blood products were distributed.
________
PRODUCT
Platelets, Pheresis. Recall #B-213-9.
CODE
Unit #8894147.
MANUFACTURER
Long Island Blood Services, A Division of New York Blood Center,
Melville, New York.
RECALLED BY
Manufacturer, by telephone on August 24, 1997. Firm-initiated
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had taken aspirin
within 72 hours of donation.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-214/215-9.
CODE
Unit #1676863.
MANUFACTURER
Mississippi Blood Services, Inc., Jackson, Mississippi.
RECALLED BY
Manufacturer, by letter dated March 17, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Mississippi and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from an unsuitable donor.
________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF; c) Platelets;
d) Fresh Frozen Plasma; e) Recovered Plasma.
Recall #B-216/220-9.
CODE
Unit numbers: a) Q24896, R18183, R63506, S21073, S60794, T57263;
b) R63506; c) Q24896, R18183, S21073, S60794, T57263;
d) T57263; e) Q24896, R18183, R63506, S21073, S60794.
MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora,
Illinois.
RECALLED BY
Manufacturer, by letter dated September 30, 1998, or by fax on
September 29, 1998. Firm-initiated recall complete.
DISTRIBUTION
Illinois, Indiana, California.
QUANTITY
a) 6 units; b) 1 unit; c) 5 units; d) 1 unit; e) 5 units were
distributed.
REASON
Blood products were collected from a donor with a history of
hepatitis.
________
PRODUCT
Blood Bank Software Versions 4.3, 5.0, 5.1, 5.2 and 5.22.
Recall #B-221-9.
CODE
Software versions 4.3, 5.0, 5.1, 5.2 and 5.22.
MANUFACTURER
Sunquest Information Systems, Inc., Tucson, Arizona.
RECALLED BY
Manufacturer, by fax on September 23, 1998. Firm-initiated field
correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
449 consignees received software.
REASON
Computer software contains programing errors which could
potentially result in the release of unsuitable blood
products.
________
PRODUCT
Platelets. Recall #B-222-9.
CODE
Unit #49W22221.
MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY
Manufacturer, by telephone on September 15, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Oklahoma.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of clotted red blood
cells.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Source Leukocytes for
Manufacturing; d) Recovered Plasma. Recall #B-224/227-9.
CODE
Unit #01Q25904.
MANUFACTURER
American Red Cross Blood Services, Syracuse, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by letter
dated July 27, 1998. Firm-initiated recall complete.
DISTRIBUTION
New York, New Jersey, California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who was implicated in
two post transfusion hepatitis cases.
________
PRODUCT
Red Blood Cells. Recall #B-229-9.
CODE
Unit #0731511.
MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, Texas.
RECALLED BY
Manufacturer, by telephone on September 3, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose body temperature
had not been documented.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-230/232-9.
CODE
Unit #V68601.
MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY
Manufacturer, by letter dated October 7, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Illinois, Indiana, Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor whose suitability was
not adequately determined.
PRODUCT
Platelets for Further Manufacture of Non-Injectable Products.
Recall #B-167-9.
CODE
Unit #61737.
MANUFACTURER
Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY
Manufacturer, by letter dated July 9, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Florida.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to
an area designated as endemic for malaria.
_________
PRODUCT
Cryoprecipitated, AHF. Recall #B-191-9.
CODE
Unit #049Z28475 and 049Z28480.
MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY
Manufacturer, by telephone on August 13, 1998, followed by letter
dated August 24, 1998. Firm-initiated recall complete.
DISTRIBUTION
Arkansas.
QUANTITY
2 units were distributed.
REASON
Unlicensed blood products were distributed in interstate commerce
without obliteration of the firm's license number.
________
PRODUCT
Red Blood Cells. Recall #B-202-9.
CODE
Unit numbers: KH87069, KH86748, KH86936, KH86937, KH86939,
KH86966, KH86968, KH87132, KH87133, KH87462.
MANUFACTURER
Virginia Blood Services, Richmond, Virginia.
RECALLED BY
Manufacturer, by letter dated September 17 and 21, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Virginia.
QUANTITY
10 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Recovered Plasma. Recall #B-203-9.
CODE
Unit numbers: 18213-3528, 18213-5729, 18213-4344.
MANUFACTURER
United Blood Services, Cheyenne, Wyoming.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated
February 11, 1998, followed by a second letter in March 1998.
Firm-initiated recall complete.
DISTRIBUTION
Switzerland.
QUANTITY
3 units were distributed.
REASON
Blood products were stored in empty ADSOL additive bags.
________
PRODUCT
Red Blood Cells. Recall #B-228-9.
CODE
Unit #5043908.
MANUFACTURER
BloodCare, Dallas, Texas.
RECALLED BY
BloodCare, doing business as Carter BloodCare, Bedford, Texas, by
letter dated July 1, 1998. Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells, Leukocytes Removed by Filtration.
Recall #B-235-9.
CODE
Unit #682812.
MANUFACTURER
Mississippi Blood Services, Inc., Jackson, Mississippi.
RECALLED BY
Manufacturer, by telephone on January 19, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Blood product may have been stored at unacceptable
temperatures.
________
PRODUCT
Platelets. Recall #B-236-9.
CODE
Unit #01GY22058 and 0lLE11717.
MANUFACTURER
American Red Cross Blood Services, Syracuse, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by letter
dated August 7, 1998. Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
2 units were distributed.
REASON
Blood products were prepared from two units of whole blood with
extended collection times.
________
PRODUCT
Platelets. Recall #B-237-9.
CODE
Unit numbers: 01GN18723 and 01KK43774.
MANUFACTURER
American Red Cross Blood Services, Syracuse, New York.
RECALLED BY
American Red Cross Blood Services, Rochester, New York, by letter
dated August 4, 1998. Firm-initiated recall complete.
DISTRIBUTION
New York.
QUANTITY
2 units were distributed.
REASON
Blood products were prepared from two units of whole blood with
extended collection times.
________
PRODUCT
Fresh Frozen Plasma. Recall #B-239-9.
CODE
Unit #10587-1970.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on August
7, 1998, and by letter dated August 20, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Arizona.
QUANTITY
1 unit were distributed.
REASON
Blood product was collected from a unit of whole blood that had
discrepant start and end times documented.
________
PRODUCT
Platelets. Recall #B-240-9.
CODE
Unit #10587-7647.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on July
21, 1998, and by letter dated August 17, 1998. Firm-initiated
recall complete.
DISTRIBUTION
Arizona.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a unit of whole blood that had
discrepant start and end times documented.
________
PRODUCT
Custom surgical trays used in surgical procedures.
Recall #Z-064/089-9.
CODE
AMC General Minor 101805, 109399, 100921
AMC Lap Chole, PDS 101256, 103276, 109398, 200040,
AMC Shoulder, PDS 100514
Arthroscopy Pack 104461
Basin Kit 107458, 101641
Basin Set 100154, 100155, 105030
Cardiac Custom Pack 103021
Cardiovascular Pack 117405
Cataract Tray 113070, 109045, 112771, 113070,
102415, 117854, 114344, 116160,
116164, 119730, 119731, 124255
Craniotomy Custom Pack 103014
C-Section Pack 104854
C-Section Custom Pack 103048
C-Section Tray 107219, 101100, 102336, 109122,
106254, 116818, 117254, 119449,
121073
Delivery Drape Basin 111810, 102409,108297, 115438
Doctors C-section Pack 121996, 123307, 113705, 114517,
110287, 116057, 118962
Lap/Pelviscopy Pack 117305, 117404, 117897
Major Custom Pack 103014
Minor Custom Pack 108732, 110026, 100926, 103401,
108732, 104707
Minor Eye Pack 120895, 124396
Minor Eye Tray 116099
Open Heart Tray 107591, 108362
Open Heart Tray Haley-Veteran 101464, 101476
Ophthalmic Pack 121640, 125215
Plastic Tray 119046, 115685, 122057
Shoulder Arthroscopy Pack 102963
Transphenoedal Pack 108427, 104494
MANUFACTURER
MedSurg Industries, Herndon, Virginia.
RECALLED BY
Manufacturer, by letter dated June 19, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,800 cases were distributed.
REASON
The foam strips used to secure suture needles were detaching from
the needle counter box.
________
PRODUCT
a) Elan Pharma EP80 Enteral Feeding Pump; b) O'Brien/KMI KM80
Feeding Pumps, used for the controlled administration of enteral
feeding formulas. Recall #Z-149/150-9.
CODE
All serial numbers.
MANUFACTURER
Elan Pharma, Inc., Smithfield, Rhode Island.
RECALLED BY
Nutrition Medical, Inc., Minneapolis, Minnesota, by "Customer
Safety Notification" dated October 8, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,170 pumps were distributed.
REASON
The devices can produce a "free flow" situation where the patient
may receive an unintended large volume of feeding solution at a
rapid rate.
________
PRODUCT
Warm-up Active Wound Therapy 2X2 Sterile Wound Cover, product
reference number 68022. Recall #Z-182-9.
CODE
Lot #WF8256.
MANUFACTURER
Augustine Medical, Inc., Eden Prairie, Minnesota.
RECALLED BY
Manufacturer, by telephone on October 16, 1998, followed by
letter October 20, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
600 wound covers were distributed.
REASON
Sterile packaging seal failure. The seal which closes the
product pouch was open on 1.2% of the product pouches
examined.
________
PRODUCT
McGaw Stratus Ambulatory Infusion Pump Model 550 w/Software
Version 2.32.00/2.42.01. Recall #Z-189-9.
CODE
Serial Numbers P63181, P63182, P64119, P64126, P64114, P64125,
P63115, P64123, P64106,P63193, P63188, P64130, P64111, P64129,
P64101, P63186, P64110, P64122, P64109, P63210, P63190, P64108,
P61131, P63187, P63185, P63184, P63179, AND P61145.
MANUFACTURER
Alphamed, Inc., Norcross, Georgia.
RECALLED BY
Manufacturer. Pumps were destroyed from 6/97 to 12/97.
Firm-initiated recall ongoing.
DISTRIBUTION
Texas.
QUANTITY
28 pumps were distributed and all but one had been returned at
time of recall initiation.
REASON
A software malfunction could cause the infusion to under infuse
in the Circadian, PCA, or Epidural modes.
________
PRODUCT
a) Richard-Allan Medical brand Disposable Endoscopic Clip Applier, Reflex ELC with Titanium Clips, Model No. 530: Richard-Allan Medical brand Disposable Laparoscopic Procedure Kits, Reflex Kits. Kits contain one Disposable Endoscopic Clip Applier, Reflex ELC with Titanium Clips, Model 530, in addition to other components, as follows: b) Cholecystectomy Kit, LAP CHOLE, Order No. C37329; c) Cholecystectomy Kit, DR. LIEFER, Order No. Q37395; d) Cholecystectomy Kit, DAVIS-MONTHAN AIR FORCE BASE, Order No. C37461; e) NISSEN KIT, Order No. C37465; f) Cholecystectomy Kit, COFFEE REG MED CTR, Order No. Q37262; g) Cholecystectomy Kit, Chole Kit, Order No. Q38103; h) Cholecystectomy Kit, LAP CHOLE, Order No. Q38121; I) Cholecystectomy Kit, LLOYD NOLAND HOSPITAL, Order No. Q38146; j) Cholecystectomy Kit, DR. SANCHEZ, Order No. Q38152. Recall #Z-201/210-9.
CODE
Lot numbers: a) 06JAN03; b) Lot date K-27JAN03, Kit exp. date: 01/2003; c) Lot date K-27JAN03, Kit exp. date: 01/2003; d) Lot date K-27JAN03, Kit exp. date: 06/99; e) Lot date K-27JAN03, Kit exp. date: 07/2002; f) Lot date K-29JAN03, Kit exp. date: 06/99; g) Lot date K-26JAN03, Kit exp. date: 06/99; h) Lot date K-27JAN03, Kit exp. date: 06/99; I) Lot date K-27JAN03, Kit exp. date: 06/99; j) Lot date K-27JAN03, Kit exp. date: 06/99.
MANUFACTURER
Imagyn Medical Technologies, Inc., Surgical Division, formerly
Richard-Allen Medical, Richland, Michigan.
RECALLED BY
Manufacturer, by fax on March 11, 16, and 17, 1998, and by
telephone beginning on March 12, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Alabama, Arizona, Illinois, Michigan, Missouri, Washington
state.
QUANTITY
1 box of 6 appliers and 59 kits were distributed.
REASON
Cracked or broken plastic cartridge on the clip applier can
affect the applier's intended function.
________
PRODUCT
a) The VACUTAINER(r) Brand Safety-Gard(tm) Needle Holder, a
reusable, non-sterile plastic holder, used in conjunction with
VACUTAINER(r) Brand Blood Collection Needles during venipuncture.
The needle holders are primary packaged 10 holders/cardboard box;
b) The VACUTAINER(r) Brand Safety-Gard(tm) Phlebotomy System
contains the Safety-Gard Needle Holder and a compatible needle
disposal container. The phlebotomy system is bulk packaged with
25 containers with 1 needle holder in a cardboard box.
Recall #Z-212/213-9.
CODE
a) Reorder No. 366207, Lot Nos. 7L650 through 7L654, 7M650, and
8A650; b) Reorder No. 366208, Lot Nos. 7L600, 7L601, 7M601,
7M602, 8A600, and 8A601.
MANUFACTURER
Becton Dickinson Vacutainer Systems, Sumter, South Carolina.
RECALLED BY
Becton Dickinson Vacutainer Systems, Franklin Lakes, New Jersey,
by telephone/fax on February 2 and 3, 1998, by letter on February
11, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
a) 72,620 holders; b) 12,475 systems were distributed.
REASON
Blood collection needles are subject to spinout (disengages) from
the holder during use.
PRODUCT
Accu-Dx Recurrent Bladder Cancer Test, used in the screening of
bladder cancer in conjunction with the scope method.
Recall #Z-009-9.
CODE
Lot No. 800081 (single unit), 7167 ( box unit/10 units/box) Lot No. 800182 (single unit), 7190 and 8318 (box unit/10 units/box).
MANUFACTURER
Organon Teknika, Dublin, Ireland.
RECALLED BY
Intercel Corporation, Rockville, Maryland (importer/developer),
by, letter dated August 5, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
California.
QUANTITY
11,083 units were distributed.
REASON
Routine stability testing at the six month station revealed the
product is losing stability.