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.
February 4, 1998 98-05
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Individual uncoded bars of "Chief Crunchie
Chocolate Sundae Bars" and cases labeled as
"Chief Crunchy Toasted Almond Bars".
Recall #F-070-8.
CODE 1637.
MANUFACTURER Kemps, Foods, Inc., Lancaster, Pennsylvania.
RECALLED BY Manufacturer, by telephone on January 8, 1998,
followed by letter on January 13, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION West Virginia, Pennsylvania, Delaware, New
York, Massachusetts, Connecticut, Maryland.
QUANTITY Firm estimated that little product remained on
market at time of recall initiation.
REASON Undeclared almonds and corn flour. Some bars
labeled as "Chief Crunchie Chocolate Sundae
Bar" actually contain "Chief Crunchie Toasted
Almond Bar".
_______________
PRODUCT Dietary supplements:
a) Maxine TR
b) DinoPals
c) Life Max
d) Jungamals (USA)
e) Jungamals (Canada) - For Export Only
f) Optipack 2000
g) Vitamin/Mineral Chewable
h) Completron
I) Completron Junior.
j) Nutrapack Tablets. Recall #F-224/233-8.
CODE GSN Batch #/Packaging lot # EXP Date:
Maxine TR -- Bulk (612-193B)/None N/A
Dino Mins -- 703-325/2080D7 EXP 04/99
LifeMax -- 704-565B/2487E7 EXP 05/99
704-565C/2488E7
704-565D/2489E7
704-565E/2490E7
704-565F/2504E7
Jungamals (USA) 701-928A/GS09471 N/A
701-928B/*GS09771
701-928C/GS09871
701-928D/GS09971
701-950A/GS13672
701-950B/GS13771
Jungamals (Canada) 701-940/GS13971 N/A
Optipak 2000 Bulk (703-424)/None N/A
Bulk (703-425)/None
Vit/Mineral Chewable 704-783/2635E7 EXP 05/00
Completron 703-306/2353E7 EXP 04/99
703-306/2418E7
Completron Jr. 703-304/2074D7 EXP 03/99
Nutrapack tablets 703-708A/1151E7 EXP 04/00
Bulk (703-624A)/None
Kids Formula * Bulk (705-648)/None N/A
FE Caps with DSS * Bulk (705-512)/None N/A
MANUFACTURER Garden State Nutritionals, Fairfield, New
Jersey.
RECALLED BY Manufacturer, by letters and fax on July 10
and 16, 1997. Firm-initiated recall complete.
DISTRIBUTION New York, Florida, Utah, New Jersey,
Massachusetts, Texas, California, Canada.
QUANTITY Firm estimates none remains on the market.
REASON Products contain excessive levels of lead.
_______________
PRODUCT Dietary Supplements:
a) Animal Shaped Children's Chewable Vitamins
with Iron and Beta Carotene, bulk
b) Poly-Tabs with Iron - Chewable, distributed
by J.J. Balan, Inc
c) Valumed Children's Chewable Multiple
Vitamins with Iron, 100 Tablets
d) Major Animal Shapes + Iron, distributed by
Major Pharmaceuticals
e) Children's Complete with Calcium, Iron, and
Minerals, bulk. Recall #F-234/238-8
CODE Bulk Animal Shaped Children's Chewable
Vitamins w/Iron & Beta Carotene CODE 2225A
(Nutro Laboratories' code).
Bulk Children's Complete with Calcium, Iron &
Minerals CODE 2288A (Nutro Laboratories'
code).
Poly-Tabs with Iron - Chewable, 100 count CODE
2225A, Lot 7C00550, NDC #0304-0900-01, Exp
3/00.
Children's Chewable Multiple Vitamins with
Iron, 100 count, CODE 2225A, Lot 7C00550, NDC
#0839-6552-06, Exp 3/00.
Animal Shapes + Iron Children's Chewable
Vitamins, 100 count, CODE 2225A, Lot 7C00550,
NDC #09040-53660, Exp 3/00.
MANUFACTURER Nutro Laboratories, Inc., South Plainfield,
New Jersey.
RECALLED BY Manufacturer, by telephone on July 7, 1997, by
fax on July 8, 1997, and by letter on July 8,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,841,719 tablets were distributed.
REASON Products contain excessive levels of lead.
_______________
PRODUCT Mint candies: a) "Misty Mints" candies in 12
oz. bags under the Plantation label and 16 oz.
bags under the Crawford Candies label
b.) "Mini-Misty Mints" candies in 12 oz. bags
under the Plantation label and 16 oz. bags
under the Crawford Candies label.
Recall #F-239/240-8.
CODE All product distributed from 1/1/97 to
5/31/97.
MANUFACTURER Plantation Candies, Inc., Telford,
Pennsylvania.
RECALLED BY Manufacturer, by letter on August 22, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Florida, Michigan,
Ohio, New York, Massachusetts, Maryland, New
Hampshire, Indiana, Delaware.
Quantity a) 2,000 pounds; b) 7,100 pounds were
distributed.
REASON Products contain the following undeclared FD&C
colors: Yellow No. 5, Blue No. 1, Red No. 3,
and Red No. 40.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Mint candies: a) "Misty Mints" candies in 14
oz. bags, 10 lb. bulk containers and 25 lb.
bulk containers under the Plantation label
b) "Mini-Misty Mints" candies in 14 oz. bags,
10 lb. bulk containers and 25 lb. bulk
containers under the Plantation label.
Recall #F-241/242-8.
CODE All product distributed from 1/1/97 to
5/31/97.
MANUFACTURER Plantation Candies, Inc., Telford,
Pennsylvania.
RECALLED BY Manufacturer, by letter on August 22, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania, New Jersey, Florida, Michigan,
Ohio, New York, Massachusetts, Maryland, New
Hampshire, Indiana, Delaware.
Quantity a) 2,000 pounds; b) 7,100 pounds were
distributed.
REASON Products contain the following undeclared FD&C
colors: Blue No. 1, Red No. 3, and Red No. 40.
_______________
PRODUCT Pinata Fillers, a mixture of candy and toys in
a plastic bag with net weight stated at 2
pounds, marketed under the Unique label.
Recall #F-243-8.
CODE None. All product in distribution.
MANUFACTURER Tzetzo Brothers, Inc., also known as Mayfair
Sales, Inc., Buffalo, New York (repacker).
RECALLED BY Unique Industries, Inc., Philadelphia,
Pennsylvania, by telephone on October 24,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 46,896 bags were distributed.
REASON Short weight - the product has 21% less weight
than declared on the label. Also the labeling
is false and misleading since it bears the
general statement "Candy made in U.S.A." while
individual candies are labeled as being
products of foreign countries.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============
_______________
PRODUCT Miochol-E (Acetylcholine Chloride) Intraocular
Solution, 20 mg/2 mL vials (NDA 20-213), Rx
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
58768-773-53 MIOCHOL-E SYSTEM PAK
NDC 58768-773-52 MIOCHOL-E WITH STERI-TAGS.
Recall #D-064-8.
CODE: LOT NO. EXP. DATE
U2282 1/98
U2282F 1/98
U2292 2/98
U2292D 2/98
U2294 2/98
U2294D 2/98
U2288 2/98
U2288D 2/98
U2290 2/98
U2290D 2/98.
MANUFACTURER OMJ Pharmaceuticals, San German, Puerto Rico.
RECALLED BY Ciba Vision Ophthalmics (CVO), Duluth,
Georgia, by letter dated October 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 53,556 units were distributed.
REASON Failed pH specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Oratrast (Barium Sulfate for Suspension), Rx
used for radiologic imaging, in 25 pound bags.
NDC #0075-0812-01. Recall #D-050-8.
CODE Lot numbers: N35905, N36008, P36106.
MANUFACTURER Centeon L.L.C., Bradley, Illinois.
RECALLED BY Rhone-Poulenc Rorer Pharmaceuticals, Inc.,
Collegeville, Pennsylvania, by letter on
November 19, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates very little product remains on
the market.
REASON Subpotent (12 month stability test point).
_______________
PRODUCT Polymyxin B Sulfate, USP, Micronized, non-sterile,
(bulk) (AADA#61-367).
Recall #D-063-8.
CODE Lot #G6Y070-61022-262 EXP 12/31/01.
MANUFACTURER Pfizer, Inc., Groton, Connecticut (contract
manufacturer/packager/labeler).
RECALLED BY Cultor Food Science, Inc., Ardsley, New York
(own label distributor), by letter on December
1, 1997. Firm-initiated recall ongoing.
DISTRIBUTION New York, Maryland, Illinois, Ohio,
California, Missouri, Pennsylvania, Minnesota,
Wisconsin, Virginia, Puerto Rico.
QUANTITY 388.75 billion units or approximately 10
pounds were distributed.
REASON Subpotent. Product labeled with assay value
of 9,252 units/mg, while product actually
contains 7,891 units/mg.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-310/311-8.
CODE Unit #N89129.
MANUFACTURER Lifeblood/Mid-South Regional Blood Center,
Memphis, Tennessee.
RECALLED BY Manufacturer, by letter dated February 14,
1996. Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received an accidental needle stick while
injecting a dog.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-454/455-8.
CODE Unit numbers: a) 6787604, 6743319, 7671435
b) 6787604, 6743319, 7671435, 7580465.
MANUFACTURER New York Blood Center, New York, New York.
RECALLED BY Manufacturer, by letter dated either December
2, 3, 9, 1996, or March 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION New York, New Jersey, Switzerland.
QUANTITY a) 3 units; b) 4 units were distributed.
REASON Blood products which tested negative for the
antibody to the human T-lymphotropic virus I
(anti-HTLV-1), but were collected from donors
who on two previous occasions, tested
repeatedly reactive for anti-HTLV-1,
Western blot negative.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-467/469-8.
CODE Unit #9Y1312.
MANUFACTURER Puget Sound Blood Center Program, Seattle,
Washington.
RECALLED BY Manufacturer, by letter dated September 18,
1997. Firm-initiated recall complete.
DISTRIBUTION Washington state, and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of exposure to hepatitis.
_______________
PRODUCT Various Human Tissues for Transplant: Bone,
skin, arteries, Achilles tendon, fascia, soft
tissue, knee block, lateral meniscus, medial
meniscus, patellar meniscus and patellar
tendon. Recall #B-472-8.
CODE Donor # CA97 10 013, CA96 11 091, BA96 04 004,
BA94 11 006, BA94 12 005, BA95 01 008, BA95 02
004, BA95 12 003, BA95 02 011, CA97 02 039,
CA97 09 043, CA97 09 007, CA97 09 001, CA97 05
064, CA97 06 090, CA97 06 077, CA97 06 075,
CA97 07 062, BA94 09 007, BA94 10 019, BA94 10
020, BA94 10 022, BA94 11 002, BA95 04 018,
BA96 04 010, BA95 03 003, BA95 04 012, BA95 02
008, BA94 11 015, BA95 08 001, BA95 08 002,
BA95 08 029.
MANUFACTURER Lions Doheny Eye & Tissue Transplant Bank, Los
Angeles, California.
RECALLED BY Manufacturer, by telephone on November 26,
1997 and by letter dated December 4, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION California, Georgia, Texas.
QUANTITY 32 various tissues.
REASON Human Tissues for Transplant, which: 1) Tested
repeatedly reactive for HIV p24 antigen; 2)
Tested repeatedly reactive for antibody to
hepatitis B core antigen (anti-HBc); 3) Tested
repeatedly reactive for the hepatitis B
surface antigen (HBsAg); 4) Tested repeatedly
reactive for antibody to the human T
lymphotropic virus type 1 (anti-HTLV-1); 5)
Tested repeatedly reactive for antibody to the
hepatitis C virus encoded antigen (anti-HCV);
6) Tested reactive for syphilis, or a
combination of the above tests.
_______________
PRODUCT Platelets. Recall #B-475-8.
CODE Unit #5056232.
MANUFACTURER LifeShare, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on September 26,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor
taking the drug Modafinal.
_______________
PRODUCT Red Blood Cells. Recall #B-483-8.
CODE Unit 12LC25270.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on November 25,
1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-484/485-8.
CODE Unit #12FJ87251.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on September 27,
1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor
taking the drug Methotrexate.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-486/487-8.
CODE Unit #12GL25713.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on August 21, 1996,
and by fax on August 22, 1996. Firm-initiated
recall complete.
DISTRIBUTION North Carolina and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Whole Blood; b) Red Blood Cells; c)
Cryoprecipitated AHF. Recall #B-488/490-8.
CODE Unit numbers: a) 12FK93071, 12LN04270,
12LE12558; b) 12FK87844, 12FK94271, 12LE10347,
12LE11321, 12FK88871; c) 12LE11321.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on July 23 or 27,
1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY a) 3 units; b) 5 units; c) 1 unit.
REASON Blood products tested negative for the
antibody to the hepatitis B core antigen
(anti-HBc), but were collected from a donor
who previously tested repeatedly reactive for
anti-HBc on two separate occasions.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-491/492-8.
CODE Unit #12FK00164.
MANUFACTURER American Red Cross Blood Services, Charlotte,
North Carolina.
RECALLED BY Manufacturer, by telephone on November 19,
1996. Firm-initiated recall complete.
DISTRIBUTION North Carolina and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in a manner that
could have compromised the sterility of the
collection system.
_______________
PRODUCT Platelets, Pheresis. Recall #B-493-8.
CODE Unit #09253.
MANUFACTURER Community Blood Center, Inc., Appleton,
Wisconsin.
RECALLED BY Manufacturer, by telephone on February 24,
1997, and by letter on February 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit collected
from a donor who had taken feldene (aspirin)
within 3 days of donation.
_______________
PRODUCT Cryoprecipitated AHF. Recall #B-494-8.
CODE Unit numbers: 60-80029 and 60-80050.
MANUFACTURER Community Blood Center, Inc., Appleton,
Wisconsin.
RECALLED BY Manufacturer, by letter dated July 1, 1996.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 2 units were distributed.
REASON Blood products were incorrectly processed.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-495/496-8.
CODE Unit numbers: a) 42FP52201, 42K86053,
42H00802, 42H01740, 42Q48915, 42FP56942,
42FJ57278; b) 42FH59471, 42FP52201, 42Q48915,
42FJ57278.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated either July 17,
18, 1997, September 15, 1997, November 17,
1997 or November 18, 1997. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY a) 7 units; b) 4 units were distributed.
REASON Blood products were collected from donors who
reported travel to areas designated as
endemic for malaria.
_______________
PRODUCT Source Plasma. Recall #B-497-8.
CODE Unit numbers: 0650169923, 0650169559,
0650168927.
MANUFACTURER NABI Bio Medical Center, Racine, Wisconsin.
RECALLED BY Manufacturer, by letter on or about August 21,
1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 3 units were distributed.
REASON Blood products were collected from an
unsuitable donor who subsequently tested
reactive for HIV-1 Ag.
_______________
PRODUCT Recovered Plasma. Recall #B-498-8.
CODE Unit #32S91.
MANUFACTURER Mayo Foundation, Division of Transfusion
Medicine, Rochester, Minnesota.
RECALLED BY Manufacturer, by letter dated March 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from autologous
donor who did not meet the criteria for
homologous use, donor taking the drug
Prednisone.
_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Platelets, Pheresis
d) Fresh Frozen Plasma. Recall #B-499/502-8.
CODE Unit numbers: a) H66413, H54647, L02729,
H15388, H11361, H08239, H00303, F71530,
F68954, F46809, F36388, F32820, F22297,
F18955, F91414
b) H15388, H00303, F91414, F46809, F22297,
F18955; c) F75267; d) F46809.
MANUFACTURER Tacoma-Pierce County Blood Bank, doing
business as Cascade Regional Blood Services,
Tacoma, Washington.
RECALLED BY Manufacturer, by letter dated August 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY a) 15 units; b) 6 units; c) 1 unit; d) 1 unit.
REASON Blood products tested negative for the
hepatitis B surface antigen (HBsAg), but were
collected from a donor who previously tested
repeatedly reactive for HBsAg, confirmatory
positive.
_______________
PRODUCT a) Red Blood Cells; b) Platelets, Pooled; c)
Recovered Plasma. Recall #B-504/506-8.
CODE Unit numbers: a) W65370, W67596, W69522,
W72292; b) FF51592, FF66640, FF59389
c) W63127, W65370, W67596, W69522, W72292.
MANUFACTURER The Blood Center of Southeastern Wisconsin,
Inc., Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter dated August 15, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin and New York.
QUANTITY a) 4 units; b) 3 units; c) 5 units were
distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
(unlicensed) negative.
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Recovered Plasma. Recall #B-507/509-8.
CODE Unit #Q44787.
MANUFACTURER The Blood Center of Southeastern Wisconsin,
Inc., Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by letter dated November 18,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
was exposed to hepatitis A.
_______________
PRODUCT Platelets. Recall #B-510-8.
CODE Unit numbers: 31LM03645, 01LM02582, 01LF00414.
MANUFACTURER American Red Cross Blood Services, Buffalo,
New York.
RECALLED BY Manufacturer, by fax on February 14, 1996,
November 27, 1996 or April 15, 1997.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 3 units were distributed.
REASON Blood products were prepared from units of
Whole Blood with extended collection times or
designated as a difficult bleed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-518-8.
CODE Unit #09799.
MANUFACTURER Community Blood Center, Inc., Appleton,
Wisconsin.
RECALLED BY Manufacturer, by telephone on May 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
medical history screening was inadequately
performed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Recovered Plasma. Recall #B-456-8.
CODE Unit numbers: 6787604, 6743319, 7671435
MANUFACTURER New York Blood Center, New York
RECALLED BY Manufacturer, by letters on either December 2,
3, 9, 1996, or March 7, 1997. Firm-initiated
recall complete.
DISTRIBUTION New York, New Jersey, Switzerland.
QUANTITY 3 units were distributed.
REASON Blood products tested negative for the
antibody to the human T-lymphotropic virus I
(anti-HTLV-1), but were collected from donors
who on two previous occasions, tested
repeatedly reactive for anti-HTLV-1, Western
blot negative.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-463/464.
CODE a) 2030365, 2030366, 2030367, 2030368,
2030375, 2030376, 2030379, 2030381, 2030373,
2030382; b) 2030365, 2030366, 2030367,
2030368, 2030375, 2030376, 2030379, 2030381,
2030373, 2030382.
MANUFACTURER LifeShare, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by letter on July 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 10 units of each component were distributed.
REASON Blood products had extended expiration dates.
_______________
PRODUCT Recovered Plasma. Recall #B-503-8.
CODE Unit numbers: H66413, H54647, L02729, H08239,
H00303, F91414, H15388, H11361, F71530,
F68954.
MANUFACTURER Tacoma-Pierce County Blood Bank, doing
business as Cascade Regional Blood Services,
Tacoma, Washington.
RECALLED BY Manufacturer, by fax on July 31, 1997,
followed by letters dated August 11, 1997, and
January 5, 1998. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 10 units were distributed.
REASON Blood products tested negative for the
hepatitis B surface antigen (HBsAg), but were
collected from a donor who previously tested
repeatedly reactive for HBsAg, confirmatory
positive.
_______________
PRODUCT Red Blood Cells. Recall #B-511-8.
CODE Unit #04KZ01162.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated August 7, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Hampshire.
QUANTITY 1 unit was distributed.
REASON Autologous blood product, which tested
positive for the hepatitis B surface antigen
(HBsAg), the antibody to the hepatitis B core
antigen (anti-HBc), and the antibody to the
hepatitis C virus encoded antigen (anti-HCV),
was distributed, contrary to the firm's
standard operating procedures.
_______________
PRODUCT Recovered Plasma. Recall #B-512-8.
CODE Unit #04KR04615.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated April 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red
Blood Cells that was implicated in a
transfusion reaction.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ==========
_______________
PRODUCT Radionics Model CTCP-2 CT Clamping Plate, used
primarily for stereotactic radiosurgery.
Recall #Z-284-8.
CODE All CTCP-P2 clamping plates manufactured since
July 1993.
MANUFACTURER Radionics, Inc., Burlington, Massachusetts.
RECALLED BY Manufacturer, by letter on November 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 106 units were distributed.
REASON The clamping plate may collide with the base
CT couch, possibly causing patient injury.
_______________
PRODUCT Reliant Power Lifts: a) Model RPA450
b) Model RPL450. Recall #Z-285/286-8.
CODE All device serial numbers beginning with 96K
through 96L and 97A through 97E, followed by
any five digit numeric combination.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
RECALLED BY Manufacturer, by letter dated November 7,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 475 lifts were distributed.
REASON The Matrix linear actuator has exhibited three
failures on a patient hoist, in each case
losing its load-carrying capacity.
_______________
PRODUCT The Fabricant System, a manual
irrigation/aspiration unit, sterile,
disposable, used to wash and aspirate saline
during eye surgery. Recall #Z-289-8.
CODE Product #9AF017, Lot number: E097,
Sterilization Date: May 1997.
MANUFACTURER U.S. Medical, Inc., Hingham, Massachusetts.
RECALLED BY Manufacturer, by telephone on December 16,
1997, followed by letter dated December 16,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY 769 units were distributed.
REASON The irrigation hole that is drilled into the
tip of the cannula was incomplete, thus
restricting liquid flow.
_______________
PRODUCT Umbilical Clamp, QFC-650, used to clamp the
umbilical cord during childbirth.
Recall #Z-292-8.
CODE All lots.
MANUFACTURER QFC Industries, Arlington, Texas.
RECALLED BY Manufacturer, by letter on November 12, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois and Virginia.
QUANTITY 79 cases (237,000 units) were distributed;
firm estimated 18 cases (54,000 units)
remained on market at time of recall
initiation.
REASON The device sometimes slips upon installation
allowing blood seepage in some cases.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I ==================
_______________
UPDATE Large volume parenterals, distributed by
Veterinary Pharmaceuticals, Inc., which
appeared in the January 21, 1998, Enforcement
Report as has been revised. The actual
products recalled and recall numbers are as
follows:
Electrolyte Solution with Dextrose - V-010-8
Calcium Gluconate 23% - V-011-8
Dextrose Sol 50% - V-012-8
Hypertonic Saline Solution 7.2% - V-013
Caldex CMPK - V-014-8
Lactated Ringer Solution - V-015-8
Sterile Water for Injection - V-016
Vitamin B Complex - V-017-8
Vitamin B Complex Fortified - V-018-8.
END OF ENFORCEMENT REPORT FOR FEBRUARY 4, 1998. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
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