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.
August 13, 1997 97-33
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Progresso 99% Fat Free White Cheddar Potato Soup,"
distributed to Von's Markets in California and Nevada.
Recall #F-626-7.
CODE K6N14.
MANUFACTURER Progresso Quality Foods, Vineland, New Jersey.
RECALLED BY The Pillsbury Company, Minneapolis, Minnesota, by
letter on July 1, 1997. Firm-initiated recall
complete.
DISTRIBUTION California and Nevada.
QUANTITY 240 cases (12 cans per case) were distributed.
REASON The product contains undeclared clams. Some cans
labeled as 99% Fat Free White Cheddar Potato Soup
actually contained 99% Fat Free New England Clam
Chowder.
_______________
PRODUCT Wakim's Homestyle Hommus with Roasted Peppers, in 8
ounce plastic tubs. Recall #F-627-7.
CODE June 29.
MANUFACTURER Wakim's Foods Inc., Bristol, Pennsylvania.
RECALLED BY Manufacturer, by press release and telephone on
July 3, 1997, followed by visit on July 4 and 5,
1997. Completed recall resulted from sample
analysis and followup by New York Department of
Agriculture and Markets.
DISTRIBUTION Pennsylvania, New Jersey, New York.
QUANTITY Firm estimates none remains on the market.
REASON The product was contaminated with Listeria
monocytogenes.
_______________
PRODUCT 7" Carrot Cakes, sold in a clear plastic dome
container. Recall #F-628-7.
CODE The product is sold under various labels but can be
identified by the last five digits of the UPC code "00722".
Only product purchased before July 7, 1997, is affected.
MANUFACTURER Knaub's Cakes, Inc., York, Pennsylvania.
RECALLED BY Manufacturer, by telephone on July 3, 1997,
followed by fax, and by press release on July 8,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Georgia.
QUANTITY Undetermined.
REASON The product contains undeclared walnuts.
_______________
PRODUCT Chocolate ice cream in half gallon paper containers,
under the Osborn label.
Recall #F-630-7.
CODE All codes.
MANUFACTURER Osborn Dairy, Sault Saint Marie, Michigan.
RECALLED BY Manufacturer, by press release by the firm in
cooperation with the Michigan Department of
Agriculture on July 3, 1996, followed by radio and
newspaper announcements, and visits. Completed
recall resulted from sample analysis and followup
by the Michigan Department of Agriculture.
DISTRIBUTION Michigan.
QUANTITY Firm estimates none remains on the market.
REASON The chocolate ice cream is contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Creative Products' Candy: a) Fish Tasting Candy; b)
Fart Candy, individually wrapped pieces of candy
attached to a display card.
Recall #F-620/621-7.
CODE All product in distribution.
MANUFACTURER F.B. Washburn Candy Corporation, Brockton,
Massachusetts.
RECALLED BY Creative Products Mfg., Inc., Bath, Pennsylvania,
by letter dated July 25, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
-2-QUANTITY a) 5,000 packages; b) 2,000 packages were distributed.
REASON a) Product contains undeclared FD&C Yellow No. 5 and
FD&C Blue No. 1.
b) Product contains undeclared FD&C Yellow No. 5, FD&C
Yellow No. 6, FD&C Blue No. 1, and FD&C Red No. 40.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Creative Products Hot Sweets Candy, individually
wrapped pieces of candy attached to a display card.
Recall #F-622-7.
CODE All product in distribution.
MANUFACTURER F.B. Washburn Candy Corporation, Brockton,
Massachusetts.
RECALLED BY Creative Products Mfg., Inc., Bath, Pennsylvania,
by letter dated July 25, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 100 packages were distributed.
REASON Product contains undeclared FD&C Red No. 40.
_______________
PRODUCT Hillside Light Sour Cream, in 16 ounce plastic cups.
Recall #F-623-7.
CODE 07-19.
MANUFACTURER Hillside Dairy Products, Cleveland Heights, Ohio.
RECALLED BY Manufacturer, by telephone on June 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 6,117 containers were distributed.
REASON The product is misbranded because the label identifies
it as "Light Sour Cream" when it in fact is regular
sour cream.
_______________
PRODUCT Product: Bean Sauce and Bean Curd Products:
a) Bean Sauce (with chili), Net Wt. 16 oz. (1 lb.) or 454
grams, in glass jars, 24 jars per case, packed by Chan Moon
Kee 7-10 Chung Ching Street Hong Kong
b) Bean Curd Preserve: Net Wt. 10 oz. (300 g) in glass jars,
48 jars per case. Sze Chuan Food Products Co., Ltd. Product
of Taiwan
c) Liu Ma Kee Preserved Bean Curd: Net wt. 454 g oz. (1 lb.)
in glass jars, 24 jars per case. Product of Hong Kong
d) Pearl River Bridge Fu Chung Brand Bean Curd, 16 oz. (1
lb.) in glass jars, 36 jars per case. Recall #F-616/619-7.
-3-CODE None.
MANUFACTURERS/ a) Chan Moon Kee, Hong Kong
PACKERS b) Szechuan Food Products Co. Ltd., Taiwan ROC
c) Chan Moon Kee, Hong Kong; d) China National Cereals,
Oils, & Foodstuffs I/F Co., The People's Republic of China.
RECALLED BY Blooming Imports, Inc., Brooklyn, New York
(importer), by letter on November 4, 1996.
Completed recall resulted from sample analysis and
followup by the New York State Department of
Agriculture and Markets.
DISTRIBUTION New York and New Jersey.
QUANTITY a) 28 cases (24 cans per case); b) Undetermined; c) 46
cases (24 cans per case);
d) 90 cartons (36 jars per case were distributed.
REASON The products are held in leaking containers. In
addition a) - c) are low acid canned foods for which no
processes have been filed. Products a) - b) are also
contaminated with filth.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT a) Gentle Lotion Cleanser and b) Triple S Gentle Wash
in 500 ml plastic pouches packed 18 per case. Recall
#F-624/625-7.
CODE a) Lot numbers: 7040351001, 7041161001, 7041231001; b)
7040941001.
MANUFACTURER Sani-Fresh International, San Antonio, Texas.
RECALLED BY Manufacturer, by letter dated July 9, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 3,640 cases (18 per case); b) 554 cases (18 per
case) were distributed.
REASON The product is contaminated with Pseudomonas
aeruginosa.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Maximum Strength Ecotrin Caplets, 500 mg, in 60 count
bottles, indicated as an analgesic/anti-inflammatory
agent.
Recall #D-239-7.
CODE Lot numbers: 6I02A and 5H14A.
MANUFACTURER Smithkline Beecham Pharmaceutical Company, Cidra,
Puerto Rico.
RECALLED BY Smithkline Beecham Consumer Healthcare,
Parsippany, New Jersey, by letter on March 10,
1997. Firm-initiated recall ongoing.
-4-DISTRIBUTION Nationwide.
QUANTITY 1,493 cases of lot 6I02A and 1,633 cases of lot 5H14A
(36 bottles per case) were distributed; firm estimated
that 150 cases remained on market at time of recall
initiation.
REASON Product failed dissolution testing (stability).
_______________
PRODUCT Health Safe Anti-Bacterial/Antiseptic Polymer Lotion
*** Safe Effective Skin Protection Against Infection
(Triclosan 0.3%), in 2, 4, 8, 16, and 32 fluid ounce
bottles.
Recall #D-242-7.
CODE Lot #"4".
MANUFACTURER Stanford Personal Care Manufacturer, Saugus,
California.
RECALLED BY AmeriCare Health Products, Marion, Illinois
(distributor), by telephone on July 1, 1997,
followed by letter July 7, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Tennessee, Illinois, Virginia, South Carolina,
Wisconsin, Indiana, Maryland, Pennsylvania.
QUANTITY 312 - 2 oz. bottles, 192 - 4 oz. bottles, 204 - 8 oz.
bottles, 432 - 16 oz. bottles and 81 - 32 oz. bottles
were distributed, with the firm estimating that 30% of
the product remains on the market.
REASON Product contamination with Pseudomonas Aeruginosa.
_______________
PRODUCT Oxygen, USP in D and E high pressure cylinders for
prescription use. Recall #D-243-7.
CODE All lots.
MANUFACTURER Prescription Oxygen Services, Sault Saint Marie,
Michigan.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
completed on July 10, 1997.
DISTRIBUTION Michigan.
QUANTITY Firm estimates none remains on the market.
REASON Current good manufacturing practice deviations.
_______________
PRODUCT Univasc Tablets, Moexipril Hydrochloride), 7.5 mg, in
bottles of 100, used in the treatment of hypertension.
Recall #D-244-7.
CODE Lot 31411.
MANUFACTURER Schwarz Pharma AG, Monheim, Germany.
-5-RECALLED BY Schwarz Pharma, Inc., Mequon, Wisconsin, by letter
on July 28, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13,010 bottles were distributed; firm estimated that
less than 10 percent of product (1,301 bottles)
remained on market at time of recall initiation.
REASON Tablet mix-up: 15 mg tablet found in 7.5 mg bottle.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Amway FormuCare Hydrocortisone Cream USP, 1%, Net
Wt. 28.35 g (1 oz.), in cartons labeled Amway
FormuCare Triple Antibiotic Ointment,
BACITRACIN-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
OINTMENT. Recall #D-240-7.
CODE Lot K500 EXP 7/00.
MANUFACTURER Thames Pharmacal Company, Ronkonkoma, New York.
RECALLED BY Amway Corporation, Ada, Michigan, by letter on
April 25, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,464 cases (4 units per case) were distributed.
REASON Packaging mix-up: Some correctly labeled tubes of
hydrocortisone cream were packaged into exterior
cartons labeled as triple antibiotic ointment.
_______________
PRODUCT Tripelennamine Hydrochloride Tablets, USP, 50 mg, in
bottles of 100 and 1,000, under the Schein label, an
anti-histamine.
Recall #D-245-7.
CODE Lot No. D6G1807.
MANUFACTURER Danbury Pharmacal, Inc., Danbury, Connecticut.
RECALLED BY Manufacturer, by letter dated May 28, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 448 1000-tablet bottles and 384 100-tablet bottles were
distributed.
REASON Subpotency due to low tablet weight.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Plasma (Cryo-Poor). Recall #B-994-7.
-6-CODE Units: 29134-5599, 29134-5280, 23134-6966, 29133-9342,
29133-9795, 29134-4614, 29134-6951, 29134-5281.
MANUFACTURER United Blood Services, Chicago,
Illinois.
RECALLED BY Manufacturer, by telephone on May 20, 1997, and by
letter on July 17, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 8 units were distributed.
REASON Blood product was subject to quarantine because it may
have been improperly tested for viral markers.
_______________
PRODUCT Red Blood Cells. Recall #B-1077-7.
CODE Unit #30166-7350.
MANUFACTURER United Blood Services, Bismarck, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on March 21, 1996. Firm-initiated
recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood
which exceeded the whole blood to anticoagulant ratio.
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma; d) Recovered Plasma.
Recall #B-1134/1137-7.
CODE Unit numbers: a) 16047-5747, 16052-7307
b) 16047-5747; c) 16047-5747
d) 16052-7307.
MANUFACTURER United Blood Services, Meridian, Mississippi.
RECALLED BY Blood Systems Inc., Scottsdale, Arizona, by letter
on March 13, 1997. Firm-initiated recall
complete.
DISTRIBUTION Mississippi, Florida, Switzerland.
QUANTITY a) 2 units; b-d) 1 unit of each component was
distributed.
REASON Blood products were drawn from an unsuitable donor.
_______________
PRODUCT Red Blood Cells. Recall #B-1142-7.
CODE Units 49FJ57215 and 49FJ57223.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on June 6, 1997, and by
letter dated June 9, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas and Oklahoma.
QUANTITY 2 units were distributed.
-7-REASON Blood products were collected from donors whose body
temperature and arm inspection had not been documented.
_______________
PRODUCT Red Blood Cells and Fresh Frozen Plasma. Recall #B-1144/1145-7.
CODE Unit #10219-4509.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale,
Arizona, by letter dated February 2, 1997. Firm-initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for viral markers, but
were collected from a donor who previously tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1 (anti-HIV-1), the
antibody to the human T-lymphotropic virus
type I (anti-HTLV-I), and the antibody to
the hepatitis C virus encoded antigen
(anti-HCV).
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Platelets, for further manufacture;
d) Plasma; e) Recovered Plasma.
Recall #B-1146/1150-7.
CODE Unit numbers: a) 16J10119, 16G02869, 16K31428, 16H98369,
16L75196, 16G07678, 16F85233, 16F85561; b) 16L75196,
16G07678, 16H98369; c) 16K31428; d) 16F85233 and 16F85561;
e) 16J10119, 16G02869, 16K31428, 16L75196, 16G07678,
16H98369.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by letters dated December 6, 1995 or
July 5, 1996, and on January 1, 1996. Firm-initiated recall complete.
DISTRIBUTION Ohio, California, New York, Switzerland.
QUANTITY a) 8 units; b) 3 units; c) 1 unit; d) 2 units; e) 6
units were distributed.
REASON Blood products tested repeatedly reactive for the hepatitis B surface
antigen (HBsAg), and were subjected
to additional retesting.
_______________
PRODUCT Platelets, Pheresis. Recall #B-1170-7.
CODE Units FH7582A and FH7582B.
MANUFACTURER Inova Blood Donor Services, Annandale,
Virginia.
RECALLED BY Manufacturer, by letter dated September 9, 1996.
Firm-initiated recall complete.
-8-DISTRIBUTION Virginia.
QUANTITY 2 units were distributed.
REASON Blood products tested negative for the HIV-1 p24 antigen, but were collected
from a donor who previously
tested repeatedly reactive for the HIV-1
p24 antigen, neutralization indeterminate.
_______________
PRODUCT Recovered Plasma. Recall #B-1171-7.
CODE Unit 3690607.
MANUFACTURER Walter Reed Army Medical Center, Washington, D.C.
RECALLED BY Manufacturer, by telephone on or about July 20,
1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history
of cancer.
_______________
PRODUCT Platelets. Recall #B-1176-7.
CODE Unit 28108-6527.
MANUFACTURER United Blood Services, San Angelo, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale,
Arizona, by telephone on June 23, 1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood Cells
which was clotted.
_______________
PRODUCT Red Blood Cells and Recovered Plasma.
Recall #B-1177/1178-7.
CODE Unit 20043-6257.
MANUFACTURER United Blood Services, Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated March 13, 1997. Firm-initiated
recall complete.
DISTRIBUTION Louisiana and Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who was
previously deferred for an unacceptable medical
history.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-1181/1183-7.
CODE Unit 20030-6759.
MANUFACTURER United Blood Services, Lafayette, Louisiana.
-9-RECALLED BY Blood Systems, Inc., Scottsdale,
Arizona, by letters dated June 19, 1997 and April
9, 1997. Firm-initiated recall complete.
DISTRIBUTION Louisiana, Nevada, North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
previously self-excluded.
_______________
PRODUCT Red Blood Cells and Recovered Plasma.
Recall #B-1184/1185-7.
CODE Unit 49F18225.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letter dated April 15, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose mother
was diagnosed as a chronic hepatitis B carrier.
_______________
PRODUCT Red Blood Cells and Recovered Plasma.
Recall #B-1186/1187-7.
CODE Unit 49F94249.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letters dated May 20 and 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Oklahoma and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the
drug Proscar.
_______________
PRODUCT Platelets. Recall #B-1188-7.
CODE Unit 29442-9680.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on May 2, 1997, and by
letter on May 22, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area
designated as endemic for malaria.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelet, Pheresis. Recall #B-1064-7.
CODE Unit #40P51318.
-10-MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on May 21, 1997. Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was distributed in interstate
commerce.
_______________
PRODUCT Red Blood Cells. Recall #B-1140-7
CODE Unit 49FJ56584.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on April 17, 1997., and
by letter on May 6, 1997. Firm-initiated recall
complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product, which was exposed to unacceptable
shipping temperatures, was distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-1143-7.
CODE Units 49FJ57215 and 49FJ57223.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by fax on June 16, 1997, Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 2 units were distributed.
REASON Blood products were collected from donors whose body
temperature and arm inspection had not been documented.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets,
Pheresis; d) Platelets for further manufacture; e)
Fresh Frozen Plasma; f) Cryoprecipitated AHF; g)
Recovered Plasma.
Recall #B-1151/1157-7.
CODE Unit numbers: a) 16H98694, 16M53382, 16L66909, 16L42628,
16M50423, 16H01422, 16K31854, 16K23045, 16H89762, 16H68912,
16J43115, 16C20823, 16T43275, 16J31608, 16F90773, 16K30301,
16L75232, 16F81105, 16H69681, 16J43222, 16G76169, 16H98667,
16K05022, 16F90341, 16L69428, 16F90770, 16G13048; b)
16H98694, 16M53382, 16L66909, 16M50423, 16K31854, 16J43115,
16T43275, 16F90773, 16L75232, 16J43222, 16G76169, 16H98667,
16L69428, 16F90770; c) 16P20198;
-11- d) 16F90341; e) 16H98694, 16M53382, 16C20823, 16H98667,
16K05022; f) 16J31608, 16K30301, 16H69681; g) 16L66909,
16L42628, 16M50423, 16H01422, 16K31854, 16K23045, 16H89762,
16H68912, 16J43115, 16T43275, 16J31608, 16F90773, 16K30301,
16L75232, 16F81105, 16H69681, 16J43222, 16G76169, 16F90341,
16L69428, 16F90770, 16G13048.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by letters dated December 6, 1995 or
July 5, 1996, and on January 1, 1996.
DISTRIBUTION Ohio, California, New York, Switzerland.
QUANTITY a) 27 units; b) 14 units; c) 1 unit; d) 1 unit; e) 5
units; f) 3 units; g) 22 units were distributed.
REASON Blood products tested repeatedly reactive for the hepatitis B surface
antigen (HBsAg), and were subjected
to additional retesting.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-1169-7.
CODE Unit #1280144.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by telephone on April 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product, which tested initially reactive for the
HIV-1 p24 antigen, and was not retested in duplicate.
_______________
PRODUCT Platelets. Recall #B-1172-7.
CODE Unit numbers: KZ36319, KZ36325-1, KZ36325-2, KZ35430,
KZ36322-1, KZ36322-2, KZ35432.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on July 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 7 units were distributed.
REASON Blood products were incorrectly tested for the HIV-1
p24 antigen.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets,
Pheresis. Recall #B-1173/1175-7.
CODE Unit numbers: a) 1210363, 1210376, 2681492, 2681527,
2681484, 2681490, 2671498, 2681500, 2681501, 2681502,
2681503, 2681504, 2681506, 2681507, 2681508, 2681511,
2681512, 2681520, 2681532, 2681535, 2681536; b) 1210372;
-12- c) 1210378, 1210381, 1210384, 1210389, 1210398.
MANUFACTURER Houchin Community Blood Bank, Bakersfield,
California.
RECALLED BY Manufacturer, by telephone on July 29, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY a) 21 units; b) 1 unit; c) 5 units were distributed.
REASON Blood products were incorrectly tested for the HIV-1
p24 antigen.
RECALLS AND FIELD CORRECTIONS -- DEVICES -- CLASS
II ========
_______________
PRODUCT Radiation Protective Devices, under the label Wolf X
Ray (Medical Division) or Flow X Ray (Dental Division:
a) Pro-tek-to PAD, Stock numbers: 75055, 75057
b) Apronettes, Stock numbers: 69095, 69096, 69097, 69098
c) Gonad Shields, Stock numbers: 755000 (Beige)
d) Thyroid Collars, 5x27
e) Easy Wrap, Stock numbers: 85020, 65021, 65022, 65023,
65024, 65025
f) Special Procedure Apron, Stock numbers: 67088,
67089
g) OR Special Procedure Apron, Stock numbers: 75062, 75063
h) Fr. Closing Spec. Proc. Apron, Stock numbers: 68090,
68091, 68092,
i) Coat Type, Stock numbers: 63002, 63013, 63001, 63011,
63074, 63075, 63015, 63016, 63071, 63073
j) Conventional Type, Stock Numbers: 62007, 62017, 62008,
62018, 62038, 62039, 62003, 62004
k) Adult Bib Apron, Stock number 75050
Child's Bib Apron, Stock number 75052
l) Thyroid Collar Only, Stock Number 75056
m) Child's Bib Apron w/collar, Stock Number 75053
n) Adult Bib Apron w/Attached Thyroid Collar, Stock number
75051
o) Panoramic X-Ray Apron, Stock number 75061.
Recall #Z-780/794-7.
CODE All aprons bearing the operator number dates between January
23, 1997 through June 11, 1997.
MANUFACTURER Wolf X-ray, West Hempstead, New York.
RECALLED BY Manufacturer, by letter June 20, 1997. Firm-initiated recall ongoing.
-13-DISTRIBUTION Nationwide and international.
QUANTITY FLOW X Ray labeled devices
Bib 555
Child apron 29
Adult apron 11
Thyroid shield 37
Panoramic apron 19
Gonad Shield 1
Special Procedures Coat 2
Easy Wrap apron 4
Front Closing apron 1
WOLF X Ray labeled devices
Conventional apron 55
Bib 380
Easy Wrap apron 341
Coat apron 168
Special procedures apron 33
Apronette 131
Wrap Around apron 29
Pro Tek To Pad 20
Gonad Shield 112
Child 19.
REASON The radiation protection devices contain lead
contaminated with small amounts of radioactive
substances.
______________
PRODUCT Leaded Radiation Protective Devices:
Product Model No.
a) Mesh, Velcro Apron MVA
Mesh, Velcro Apron OR MVA-OR
Mesh Buckle Apron MBA
Velcro Apron VA
Buckle Apron BA
Tie Apron TA
Half Apron HA
Wrap-Around Apron WA
b) Skirt/Vest (2 Piece Set) SV
c) Thyroid Collar TC
d) Gonadal Shield, 3"x5" GS35
Gonadal Shield, 5"x7" GS57
Gonadal Shield, 7"x9" GS79.
Recall #Z-803/806-7.
CODE Recall covers the identified devices with Quality Control
Numbers beginning with "1405", "1443" or "1456".
MANUFACTURER The Kennedy Company, Scottsboro, Alabama (supplier
leaded vinyl)
Pro-Tech X-Ray, Inc., Tallassee, Alabama (finished product).
RECALLED BY Pro-Tech X-Ray, Inc., Tallassee, Alabama, by
telephone from July 3, 1997 through July 7, 1997.
Firm-initiated recall complete.
-14-DISTRIBUTION Nationwide.
QUANTITY 200 devices were distributed.
REASON The radiation protection devices contain lead
contaminated with small amounts of radioactive
substances.
_______________
PRODUCT CRITIKON Complete Inflation Systems
a) CRITIKON Complete Inflation System,
b) CRITIKON Soft Complete System
c) Complete Inflation System.
Recall #Z-813/815-7.
CODE Product Number Lot Numbers
a) 22810697 0997,
22830067 0977, 0987
22850797 0987
b) 25800537 0557, 0777, 0787,
0797, 0807,
25810797 0807, 0847, 0917,
0947
c) 23800157 0437, 1077
23810167 0227, 0327, 0917,
0927
23830147 0157, 0367, 0707,
1017.
MANUFACTURER Surgikos S.A. de C.V., Chihuahua, Mexico.
RECALLED BY Johnson & Johnson Medical, Inc., Tampa, Florida,
by letter on May 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 7,185 devices were distributed; firm estimated that
3,000 devices remained on market at a time of recall
initiation.
REASON The inflation systems have latex bulbs but are labeled
as "latex free" on the devices.
_______________
PRODUCT Stryker Instruments brand 1.5 mm Drill Bits:
a) Short, Part #5110-100-15; b) Medium, Part #5120-100-15.
Recall #Z-818/819-7.
CODE Lot numbers: a) 97051285; b) 97056265 and 97062255.
MANUFACTURER Stryker Instruments, Division of Stryker
Corporation, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter on July 2, 1997. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Illinois, Louisiana,
Maryland, Michigan, South Carolina, Texas,
Wisconsin, Hong Kong.
QUANTITY 185 drill bits were distributed.
REASON The drill bits may break during use at maximum speed,
resulting in injury to the patient or user.
-15-_______________
PRODUCT Couer PCA-10 Disposable Angiography Syringes a) Part
No. C305-1035 (bulk, non-sterile);
b) Part No. C305-0035 (individual, sterile).
Recall #Z-820/821-7.
CODE All lot numbers.
MANUFACTURER Coeur Laboratories, Inc., Raleigh, North Carolina.
RECALLED BY Manufacturer, by letter on May 20, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY a) 36,000 units; b) 5,400 units were distributed.
REASON There may be air leakage into syringes during
aspiration due to a poor seal between the barrel and
the plunger.
_______________
PRODUCT Flowselector, allows the user to switch between one of
three ports for delivering oxygen without having to
rearrange the tubing from the flowmeter:
a) Precision Medical Label, Model No. PM1000;
b) Medical Fittings Label, Model No. MF8025.
Recall #Z-824/825-7.
CODE All products.
MANUFACTURER Precision Medical, Inc., Northampton,
Pennsylvania; Medical Fittings, Northampton,
Pennsylvania.
RECALLED BY Precision Medical, Northampton, Pennsylvania, by
letter on or about July 29, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Undetermined.
REASON The complete directions for use are on the box the
product is distributed in, but not on the product's
immediate labeling. The box and the directions are
discarded after the device is installed.
_______________
PRODUCT Radiation Protective Devices:
a) Small Half-Apron, Model No. AHS-18, Regular Half-Apron,
Model No. AHR-24;
b) Thyroid Collar, Model No. LTC-60;
c) Small Gonadal Shield, Model LGS-10, Medium Gonadal
Shield, Model LGM-20, Large Gonadal Shield, Model No.
LGL-30, Gonadal Shield Set (1 of each size) Model No.
LGA-50;
d) Small/Medium Mitten, Model No. LMS-12, Large Mitten,
Model No. LML-15;
-16- e) Small Lead Blanket, Model No. LBC-18, Medium Lead
Blanket, Model No. LBC-24, Large Lead Blanket, Model No.
LBC-48.
Recall Z-827/831-7.
CODE Serial numbers -- Model No. AHS-18:
001365, 001366, 001367, 001399, 001404, 001405, 001408,
001480, 001485, 001495, 001496, 001497, 001498, 001499,
001500, 001506, 001507, 001508, 001509, 001510, 001511,
001585, 001593, 001594, 001595, 001596, 001597, 001598,
001599, 001600, 001601, 001602, 001628, 001629, 001630,
001647.
Model No. AHR-24:
001368, 001369, 001370, 001381, 001382, 001406, 001407,
001477, 001479, 001512, 001530, 001531, 001532, 001648,
001649.
Model No. LTC-60:
001478, 001501, 001502, 001503, 001504, 001505, 001524,
001548, 001549, 001550, 001551, 001552, 001553, 001554,
001571, 001572, 001573, 001574, 001575, 001576, 001577,
001578, 001579, 001580, 001581, 001582, 001586, 001591,
001592, 001623, 001624, 001626, 001627, 001636, 001645,
001646, 001655, 001656, 001657.
Model No. LGS-10:
001386, 001452, 001455, 001492, 001527, 001538, 001539,
001540, 001541, 001542, 001543, 001555, 001558, 001562,
001565, 001567, 001611, 001614, 001617, 001620, 001631,
001638, 001642, 001666.
Model No. LGM-20:
001389, 001453, 001456, 001528, 001544, 001556, 001559,
001563, 001568, 001583, 001589, 001590, 001603, 001604,
001605, 001606, 001607, 001608, 001609, 001610, 001612,
001615, 001618, 001621, 001625, 001632, 001637, 001639,
001643, 001651, 001667.
Model No. LGL-30:
001376, 001377, 001380, 001387, 001388, 001392, 001393,
001401, 001402, 001403, 001416, 001417, 001418, 001419,
001420, 001424, 001425, 001426, 001427, 001428, 001429,
001430, 001431, 001432, 001433, 001437, 001450, 001454,
001457, 001458, 001459, 001460, 001487, 001488, 001493,
001529, 001545, 001557, 001560, 001564, 001566, 001569,
001587, 001588, 001613, 001616, 001619, 001622, 001633,
001634, 001635, 001640, 001641, 001644, 001652, 001664,
001665, 001668.
-17- Model No. LGA-50:
(Serial Nos. are those on the individual shield): 001383,
001384, 001385, 001409, 001410, 001411, 001412, 001413,
001414, 001438, 001439, 001440, 001441, 001442, 001443,
001444, 001445, 001446, 001462, 001463, 001464, 001465,
001466, 001467, 001468, 001469, 001470, 001471, 001472,
001473, 001489, 001490, 001491, 001658, 001659, 001660,
001661, 001662, 001663.
Model No. LMS-12:
001362, 001363, 001364, 001481, 001482, 001483, 001484,
001561, 001650, 001653, 001654.
Model No. LML-15: 001525, 001526, 001547.
Model No. LBC-18: 001522, 001523, 001546.
Model No. LBC-24: 001570.
Model No. LBC-48: 001345, 001475, 001476, 001494.
MANUFACTURER Techno-Aide, Division of National Service
Industries, Inc., Nashville, Tennessee (Finished
Devices).
The Kennedy Company, Scottsboro, Alabama (Supplier Leaded
Vinyl).
RECALLED BY Techno-Aide, Nashville, Tennessee, by letter dated
July 14, 1997. Firm-initiated recall ongoing.
QUANTITY 283 devices were distributed.
REASON Radiation protection devices contain lead contaminated
with small amounts of radioactive substances.
_______________
PRODUCT Dimension Clinical Chemistry Systems, used for glucose
testing:
a) Model XL, All Serial Numbers manufactured since 7/13/97;
b) Model RxL, All Serial Numbers manufactured since
10/21/96. Recall #Z-832/833-7.
CODE a) All serial numbers manufactured since 7/13/95; b) All
serial numbers manufactured since 10/21/96.
MANUFACTURER Dade International, Newtown, Connecticut
(instrument); Dade International, Newark, Delaware
(reagent cartridge).
RECALLED BY Dade International, Newark, Delaware, by letter
dated May 7, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY a) 231 units; b) 68 units were distributed.
-18-REASON When the devices perform testing using Glucose Flex
reagent cartridges, they report unflagged glucose
results which can be as much as 40% below expected
values.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT AMRESCO LDH-L Reagent, Catalog No. 7711, for the
quantitative determination of lactate dehydrogenase
(LDH) activity in human serum. Recall #Z-801-7.
CODE Lot No. 3017A67.
MANUFACTURER AMRESCO, Inc., Solon, Ohio.
RECALLED BY Manufacturer, by letter on July 18, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Florida and Texas.
QUANTITY 9 kits were distributed.
REASON The device contains less of the powdered reagent than
is labeled.
_______________
PRODUCT 1.3mm Ti Box Plate (Bone Fixation Plate), Part 421.095,
an orthopaedic medical device used for bone fixation.
Recall #Z-808-7.
CODE Lot No. A3GL518.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania, by memorandum
on November 12, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 50 units were distributed.
REASON The plates immediate container was identified with a
green colored label instead of a yellow colored label.
_______________
PRODUCT 1.3mm Ti Oblique L-Plate (Bone Fixation Plate), Part
421.052, an orthopaedic medical device used for bone
fixation.
Recall #Z-809-7.
CODE Lot No. A3GK392.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania, by memorandum
on April 24, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON The plates immediate container was identified with a
green colored label, which is used for 1.0mm plates,
instead of a gold colored label.
-19-_______________
PRODUCT 1.7mm Ti Emergency Screws with Fluted Tips, orthopaedic
medical devices used for bone fixation: a) 1.7mm Ti
Emergency Screw (5mm), Part 400.655; b) 1.7mm Ti
Emergency Screw (3mm), Part 400.653. Recall #Z-810/811-7.
CODE Lot Numbers: a) A3GJ390; b) A3GJ393.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania, by memorandum
on April 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, Virginia, North Carolina, South
Carolina, Kentucky, Florida, Texas, Minnesota,
Wisconsin, Ohio, Kansas, California.
QUANTITY Firm estimates none remains on the market.
REASON The screws were anodized with a gold color instead of a
teal color.
_______________
PRODUCT 1.5mm Ti L-Plate, Part 446.516, orthopaedic medical
device used for bone fixation.
Recall #Z-812-7.
CODE Lot No. A3IC949.
MANUFACTURER Synthes (USA), Monument, Colorado.
RECALLED BY Synthes (USA), Paoli, Pennsylvania, by memorandum
on September 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION Texas, Kansas, Missouri, Arkansas, Pennsylvania.
QUANTITY Firm estimates none remains on the market.
REASON The screws were anodized with a gold color instead of a
teal color.
-20-
END OF ENFORCEMENT REPORT FOR AUGUST 13, 1997. BLANK PAGES MAY
FOLLOW.
####
End of Enforcement Report for August 13, 1997
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