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 20, 1997 97-34
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Sugar Free Assorted Cookies, manufactured for BJ's Wholesale Club, packaged in
2 pound boxes. Recall #F-636-7.
CODE All product distributed between May 1, 1997 through July 10, 1997.
MANUFACTURER The Cookie Jar, Centry Cookies, Division of Boca Foods, Harrison, New
Jersey.
RECALLED BY BJ's Wholesale Club, Natick, Massachusetts, by E-mail and by press release
on July 10, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Maine, Rhode Island, Connecticut, Massachusetts, New Hampshire, New
York, New Jersey, Delaware, Pennsylvania, Maryland, Virginia, Florida.
QUANTITY Approximately 9,500 boxes were distributed.
REASON The product contains undeclared peanut, oat, and soy based ingredients.
_______________
PRODUCT a) Butterfinger Ice Cream, retail and bulk sizes under the Genesee Farms label.
b) Mexican Sundae Ice Cream, retail and bulk sizes under the Genesee Farms label.
c) Snookers Ice Cream, retail and bulk sizes under the Genesee Farms label.
d) Pralines & Cream Ice Cream, retail and bulk sizes under the Genesee Farms label.
e) Chocolate Fudge Delight Ice Cream, retail and bulk sizes under the Genesee Farms
label.
f) Peanut Butter Cup Ice Cream, retail sizes under the Genesee Farms label.
g) Chocolate and Peanut Butter Ice Cream, retail sizes under the Genesee Farms label.
h) Butter Pecan Ice Cream, retail sizes under the Genesee Farms label.
Recall #F-637/644-7.
CODE All product bearing partial or no ingredient statements.
MANUFACTURER Genesee Farms, Batavia, New York.
RECALLED BY Manufacturer, by letter dated February 25, 1997 and by visit. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY Approximately 560 various size containers remained on the market at the time the
recall was initiated.
REASON a) Undeclared peanuts and FD&C Yellow No. 5.
b), c) Undeclared peanuts.
d) Undeclared pecans.
e) Undeclared walnuts and wheat flour.
f), g) Undeclared peanuts.
h) Undeclared pecans and FD&C Yellow No. 5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT a) Butter Pecan Ice Cream, bulk size under the Genesee Farms label.
b) Heavenly Hash Ice Cream, retail and bulk sizes under the Genesee Farms label.
c) Chocolate Almond Ice Cream, retail sizes under the Genesee Farms label.
d) Heath Bar Crunch Ice Cream, retail and bulk sizes under the Genesee Farms label.
e) Cookies & Cream Ice Cream, retail and bulk sizes under the Genesee Farms label.
f) Pistachio Nut Ice Cream, retail sizes under the Genesee Farms label.
g) Pistachio Nut Ice Cream, bulk size under the Genesee Farms label.
-2- h) Butter Crunch Ice Cream, retail and bulk sizes under the Genesee Farms label.
i) Vanilla and Orange Sherbet, retail and bulk sizes under the Genesee Farms label.
j) Superman Ice Cream, retail and bulk under the Genesee Farms label.
k) Banana Ice Cream, retail and bulk sizes under the Genesee Farms label.
l) Peppermint Chip Ice Cream, retail and bulk sizes under the Genesee Farms label.
m) Vanilla:Chocolate:Strawberry Ice Cream, retail and bulk sizes under the Genesee
Farms label.
n) Crazy Peppermint Ice Cream, retail and bulk sizes under the Genesee Farms label.
o) Vanilla Ice Cream, half gallon cartons, labeled as Genesee Farms Family Pack.
p) Chocolate Thunder Ice Cream, pint tubs, sold under the Oliver's label.
q) Chocolate Almond Frozen Yogurt, retail size under the Genesee Farms label.
r) Bananaberry Frozen Yogurt, retail and bulk sizes under the Genesee Farms label.
s) Peach Frozen Yogurt,retail and bulk sizes under the Genesee Farms label.
t) Pumpkin Frozen Yogurt,retail and bulk sizes under the Genesee Farms label.
u) Orange Sherbet, retail and bulk sizes under the Genesee Farms label.
v) Lemon Sherbet, retail and bulk sizes under the Genesee Farms label.
w) Lime Sherbet, retail and bulk sizes under the Genesee Farms label.
x) Rainbow Sherbet, retail and bulk sizes under the Genesee Farms label.
Recall #F-645/668-7.
CODE All product bearing partial or no ingredient statements.
MANUFACTURER Genesee Farms, Batavia, New York.
RECALLED BY Manufacturer, by letter dated February 25, 1997, and by visit. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY Approximately 850 various sized containers remained on the market at time the
recall was initiated.
REASON a) Undeclared FD&C Yellow No. 5 (the
undeclared pecans are unlikely to pose a
hazard to health as they are named in the
product's identity).
b), c), d) Undeclared almonds.
e) Undeclared wheat flour.
-3- f) Undeclared pistachios and FD&C Yellow
No. 5.
g) Undeclared FD&C Yellow No. 5 (the
undeclared pistachios are unlikely to pose
a hazard to health as they are named in the
product's identity).
h) - p) Undeclared FD&C Yellow No. 5.
q) Undeclared almonds.
r) Undeclared FD&C Yellow No. 5, FD&C Yellow
No. 6, and FD&C Red No. 40.
s) Undeclared FD&C Yellow No. 6.
t), u) Undeclared FD&C Yellow No. 6 and FD&C
Red 40.
v) Undeclared FD&C Yellow No.5 and FD&C Yellow
No. 6.
w) Undeclared FD&C Yellow No.5 and FD&C Blue
1.
x) Undeclared FD&C Yellow No.5, FD&C Yellow
No. 6, FD&C Red 40, FD&C Red 3, and FD&C
Blue 1.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III =========
_______________
PRODUCT Sea Deli brand Fresh Frozen Shrimp, product of Panama, in 5 pound cartons.
Recall #F-631-7.
CODE Lot #90209 and 90306.
MANUFACTURER Sea-Deli Panama, S.A. Panama R Dep.
RECALLED BY Darik Enterprises, Inc., Woodside, New York (importer), by telephone, fax
and by express mail letters dated June 17, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION New York, Massachusetts, Florida, Illinois.
QUANTITY Approximately 100 5-pound cartons of lot 90306 and 102 5-pound cartons of lot
90209 were distributed.
REASON Product may contain pieces of metal.
_______________
PRODUCT Minute Maid Punch, 10-packs:
a) Berry Punch; b) Tropical Punch; c) Fruit Punch. Recall #F-632/634-7.
a) Minute Maid Berry Punch:
Package Code: Case Code:
NOV2397H NOV2397
OCT0297H OCT0279
DEC0297H DEC0297
b) Minute Maid Tropical Punch:
Package Code: Case Code:
OCT0897H OCT0897
NOV1497H NOV1497
NOV1597H NOV1597
Minute Maid Fruit Punch:
-4- c) Package Code: Case Code:
OCT0297H OCT0297
NOV1397H NOV1397
NOV1497H NOV1497
DEC0897H DEC0897
DEC0997H DEC0997
MANUFACTURER The Minute Maid Company, Hightstown, New Jersey.
RECALLED BY The Minute Maid Company, Houston, Texas, by telephone on June 19,
1997, followed by visit. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, New York, Pennsylvania, Maryland, Connecticut, Virginia,
Vermont, Maine, New Jersey, Texas, New York, Florida.
QUANTITY 9,762 cases were distributed.
REASON The products are labeled 100% fruit juice on the outer labeling when in fact they
are 10% juice.
_______________
PRODUCT Various ice cream, frozen yogurt, and sherbet:
a) Orange Mango Fat Free Ice Cream, retail and bulk sizes under the Genesee Farms label.
b) Cappuccino Fat Free Ice Cream, retail and bulk sizes under the Genesee Farms label.
c) Peanut Butter Cup Ice Cream, bulk size under the Genesee Farms label.
d) Chocolate and Peanut Butter Ice Cream, bulk size under the Genesee Farms label.
e) Chocolate Almond Ice Cream, bulk size under the Genesee Farms label.
f) Chocolate Almond Frozen Yogurt, bulk size under the Genesee Farms label.
g) Black Raspberry Frozen Yogurt, retail and bulk sizes under the Genesee Farms label.
h) Strawberry Frozen Yogurt, retail and bulk sizes under the Genesee Farms label.
i) Red Raspberry Sherbet, retail and bulk sizes under the Genesee Farms label.
j) Strawberry Sherbet, retail and bulk sizes under the Genesee Farms label.
k) Black Raspberry Sherbet, retail and bulk sizes, under the Genesee Farms label.
Recall #F-669/679-7.
CODE All products bearing partial or no ingredient statements.
MANUFACTURER Genesee Farms, Batavia, New York.
RECALLED BY Manufacturer, by letter dated February 25, 1997, and by visit. Firm-initiated recall complete.
DISTRIBUTION New York.
-5-QUANTITY Approximately 340 various sized containers remained on the market at the time the
recall was initiated.
REASON a) and b) Undeclared aspartame. In addition, it does not bear the required
aspartame warning statement.
c) to f) The products do not bear ingredient statement, the undeclared nut component
does not pose a hazard to health as an individual sensitive to that nut would avoid the
product based on its name only.
g) Undeclared FD&C Red No. 40 and FD&C Blue No. 1.
h) Undeclared FD&C Red No. 40.
i) Undeclared FD&C Red No. 40, FD&C Red No. 3, and FD&C Blue No. 1.
j) Undeclared FD&C Red No. 40.
k) Undeclared FD&C Red No. 40 and FD&C Blue No. 1.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
==========
_______________
PRODUCT REVCO brand Decongestant Cold Tablets, Multi-Symptom, (Acetaminophen 325
mg/Chlorpheniramine Maleate 2 mg/Phenylephrine HCl 5 mg), OTC, in bottles of
40.
Recall #D-237-7.
CODE Lot #ZB6K57.
MANUFACTURER Pharmaceutical Formulations, Inc., Edison, New Jersey.
RECALLED BY Manufacturer, by letter on January 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, South Carolina, Indiana, North Carolina.
QUANTITY 15,336 bottles were distributed.
REASON Product failed content uniformity for chlorpheniramine maleate due to low tablet
weights.
_______________
PRODUCT Benadryl Itch Stopping Gel, Original Strength, (1%), in 4 fluid ounce containers.
Recall #D-246-7.
CODE Lot #80236L.
MANUFACTURER Paco Pharmaceutical Services, Lakewood, New Jersey.
RECALLED BY Warner-Lambert Company, Consumer Healthcare Division, Morris Plains,
New Jersey, by letter dated April 14, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
-6-REASON Product fails to meet zinc acetate content specifications throughout shelf-life
(stability).
_______________
PRODUCT Choledyl SA Tablets (Oxtriphylline, USP), Extended Release, 600 mg, Rx, in
bottles of 100, indicated for the relief of acute and chronic bronchial asthma and
chronic bronchial asthma and for reversible bronchospasm associated with chronic
bronchitis and emphysema. Recall #D-247-7.
CODE Lot #77435D EXP 4/97.
MANUFACTURER Warner Lambert Company, Morris Plains, New Jersey.
RECALLED BY Manufacturer, by letter on February 21, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 562,100 tablets were distributed; firm estimated that less than 5,000 tablets
remained on market at time of recall initiation.
REASON Dissolution failure.
_______________
UPDATE Recall #D-187-7, Benadryl Itch Stopping Gel, 2%, Extra Strength, in 4 ounce
containers, which appeared in the June 18, 1997, Enforcement Report has been
extended to include lot numbers 80936L, 80046L, 80946L.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Fresh Frozen Plasma; b) Plasma (Cryo-Poor).
Recall #B-995/996-7.
CODE Unit numbers: a) 29270-9489; b) 29135-0725, 29134-9964, 23134-9976, 29134-8606,
29135-0080, 29134-1983.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on May 20, 21, 23 and 27, 1997, and by letter
on June 24, 1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY a) 1 unit; b) 6 units were distributed.
REASON Blood products were subject to quarantine because they may have been improperly
tested for viral markers.
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-1138/1139-7.
CODE Unit #20261-2339.
-7-MANUFACTURER United Blood Services, Lafayette, Louisiana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter on February 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were drawn from a donor whose suitability was not adequately
determined.
_______________
PRODUCT Plasma (Cryo-Poor). Recall #B-1190-7.
CODE Unit 29134-4493.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on May 7, 1997, and by letter on June 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was subject to quarantine because it may have been improperly
tested for viral markers.
_______________
PRODUCT Plasma (Cryo-Poor). Recall #B-1191-7.
CODE Unit 29134-0100.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on May 5, 1997, and by letter on June 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was subject to quarantine because it may have been improperly
tested for viral markers.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis; d) Plasma, Cryo-depleted.
Recall #B-1194/1197-7. (Extension of Recall #B-1023/1025-7 which appeared in the July
30, 1997 Enforcement Report).
CODE Units collected on August 1, 1996. Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 594-1191 for individual unit numbers recalled.
MANUFACTURER New York Blood Services, also known as New York Blood Center, New
York, New York.
RECALLED BY Manufacturer, by letter dated April 30, 1997. Firm-initiated recall ongoing.
DISTRIBUTION New York and New Jersey.
QUANTITY a) 70 units; b) 45 units; c) 1 unit; d) 5 units were distributed.
-8-REASON Blood products may have been improperly tested (fixed plates) for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1).
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1198/1199-7. (Extension of Recall #B-1052/1053-7 which appeared in the July
30, 1997 Enforcement Report).
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301)
594-1191 for individual unit numbers recalled.
MANUFACTURER New York Blood Services, also known as New York Blood Center, New
York, New York.
RECALLED BY Manufacturer, by letter dated April 30, 1997. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY a) 33 units; b) 27 units were distributed.
REASON Blood products may have been improperly tested for the antigen to the human
immunodeficiency virus type 1 (HIV-1 p24 Antigen).
_______________
PRODUCT CPD Red Blood Cells. Recall #B-1201-7.
CODE Unit #33LT64266.
MANUFACTURER American Red Cross, Farmington, Connecticut.
RECALLED BY Manufacturer, by telephone and letter on February 25, 1997. Firm-initiated
recall complete.
DISTRIBUTION Connecticut.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with extended expiration date.
_______________
PRODUCT Haemonetics Plasma Collection System-2 (PCS-2) Software. Recall #B-1202-7.
CODE All Software Versions prior to revision "F".
MANUFACTURER Haemonetics Corporation, Braintree, Massachusetts.
RECALLED BY No notification by firm. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,295 PCS-2 devices were distributed.
REASON The PCS-2 Software Version, prior to revision "F", allows condensation to build
up in the bowl which causes the voltage produced by the sensing system to fall
below operating levels triggering a safety system to stop the collection process of
a donor.
-9-_______________
PRODUCT Red Blood Cells. Recall #B-1203-7.
CODE Unit #4812368.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter on May 2, 1997. 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 a) Red Blood Cells; b) Cryoprecipitate;
c) Recovered Plasma. Recall #B-1204/1206-7.
CODE Unit #4657946.
MANUFACTURER BloodCare Dallas, Texas.
RECALLED BY Manufacturer, by letter dated April 23, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of cancer.
_______________
PRODUCT Red Blood Cells. Recall #B-1211-7.
CODE Unit #21-GJ77033.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter on June 11, 1997. Firm-initiated recall complete.
DISTRIBUTION California.
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 Plague Vaccine, USP. Recall #B-1218-7.
CODE Lot #0829Y1.
MANUFACTURER Greer Laboratories, Lenoir, North Carolina.
RECALLED BY Manufacturer, by letter on June 30, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,895 vials were distributed.
REASON Vaccine has demonstrated in the firm's stability program to have decreased
potency, although the vaccine met potency requirements at release.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelet Concentrate. Recall #B-1200-7.
-10-CODE Unit KH76925.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on May 20, 1997. Firm-initiated recall
complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with hemochromatosis.
_______________
PRODUCT Red Blood Cells. Recall #B-1207-7.
CODE Unit #4817949.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by telephone on January 3, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined due to slow bleed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=========
_______________
PRODUCT Penlon Sigma Elite Vaporizer.
Recall #Z-689-7.
CODE None.
MANUFACTURER Penlon Ltd., Abingdon, Oxon, England.
RECALLED BY Manufacturer, by letters on March 7, 1997, and by fax on May 22, 1997,
and July 21, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON The device does not properly fit a specific model of anesthesia machine (Ohmeda
Model 8000); use with this machine may result in leaks and patient injury.
_______________
PRODUCT Dial Brand Acid Concentrate for Bicarbonate Dialysis Product #AC-DM-08.
Recall #Z-798-7.
CODE Lot 624313C.
MANUFACTURER Gambro Healthcare, Deland, Florida.
RECALLED BY Manufacturer, by -letter dated April 14, 1997. Firm-initiated recall
complete.
DISTRIBUTION New Jersey, California, Pennsylvania, Florida, New York, Maryland,
Massachusetts, Illinois, Virginia, Iowa.
QUANTITY 124 cases (4 gallons per case) were distributed.
REASON The concentrate may contain mold.
-11-_______________
PRODUCT Dial Brand Acid Concentrate for Bicarbonate Dialysis Product #AC-2412, in 1
gallon containers. Recall #Z-800-7.
CODE Lot 714503C.
MANUFACTURER Gambro Healthcare, Deland, Florida.
RECALLED BY Manufacturer, by telephone on June 20, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 961 cases (4 units per case) were distributed.
REASON The concentrate had been contaminated with Peracetic Acid during the
manufacturing process.
_______________
PRODUCT Punctur-GuardR Blood Collection Needles, Product Code 4222. Recall #Z-807-7.
CODE Master Lot #M1362210; Lot #s L2151C, L2251C, L2751C, L2851C, L2852C, L2951C,
L3051C, M0151C, M0451C, M0551C, M0651C, M0751C, M0851C, M1151C, M1251C,
M1351C, M1551C, M1851C, A1061C, A1161C, A1261C, A1561C, A1761C, A1961C.
MANUFACTURER Bio-Plexus, Inc., Vernon, Connecticut.
RECALLED BY Manufacturer, by letter on May 12, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 92,900 units were distributed.
REASON The blunting member (safety mechanism) separates from the rest of the device and
remains stuck in the tip of the vacuum tube.
_______________
PRODUCT Laurus Push & Catch Suturing Devices, used in general suturing applications
during open or endoscopic surgery:
a) Model No. 10-1032; b) Model No. 40-2025.
Recall #Z-834/835-7.
CODE Lot Numbers: a) 017711; b) 017710, 024708, 065701.
MANUFACTURER Gish Biomedical, Inc., Irvine, California.
RECALLED BY Laurus Medical Corporation, Irvine, California, by letters dated April 25,
1997, and May 2, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 415 units were distributed.
REASON Under certain conditions, the pull strength in the drive mechanism may be lower
than the firm's specifications, which if exceeded, the wire which connects the
button to the drive mechanism can separate rendering the instrument
non-functional.
-12-_______________
PRODUCT Chief 107SR "Stand O Sheer Recline" Powered Wheelchair, designed to transport
and to assist a paraplegic to an upright position.
Recall #Z-838-7.
CODE Serial Nos. 21448, 21680, 21820, 21939, 22121, 22682, 22914.
MANUFACTURER Redman, Inc., Tucson, Arizona.
RECALLED BY Manufacturer, by letter dated April 17, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Virginia, Utah, Tennessee, New Jersey, Missouri, Illinois.
QUANTITY 15 units were distributed.
REASON A frame fracture at the gooseneck section of the wheelchair may occur when there
is a hole drilled in the that section during manufacture, or when the weight of the
user exceeds 190 pounds.
_______________
PRODUCT Personnel and Patient Protective Shields:
a) Apron, Product Nos. 67400, 60947, 66400, 61420, 67405, 60948, 60895, 60949,
65300, 60030, 65350, 60008, 66450, 60949, 66425, 60975, 65320, 60034, 65319, 60032,
65399, 60897, 66036, 60036, 66037, 60037, 66038, 60038, 66039, 60039, 66926, 66927,
66928, 66929, 66924, 60924, 600926, 600927, 600928, 600929
b) Skirts/Vest, Product Nos. 66650, 66655, 66660, 66665, 63259, 64075, 67130, 69205,
66605, 66610, 66615, 66620, 64250, 63601, 67320, 69106
c) Thyroid Collars, Product Nos. 60821, 66821, 69997, 66997
d) Breast Stoles, Product Nos. 60939, 66930
e) Gonad Shields, Product Nos. 63923, 65923, 65950
f) Diapers, Product No. 60923
g) Gloves, Product Nos. 69303, 69304, 69304, 69300, 69299, 69309, 69325, 69360,
69358, 69359, 695550
h) Curtains/Barriers, Product Nos. 62531, 62532, 62533, 62534, 62535, 62540, 67326,
62307, 64251, 64055, 68218, 67444, 61937, 61938, 61939, 63101, 64101, 60101, 61101,
65101, 66101, 68451, 68472, 68432, 68454, 68429, 68446, 68450, 68469, 68477, 68452,
68415, 68456, 68424, 68437, 68447, 68455, 68460, 68333, 68433, 68478, 68457, 68466,
68402, 68413, 68458, 68435, 68443, 68439, 68462, 68336, 68475, 68453, 68465.
Recall #Z-839/846-7.
-13-CODE Finished product shipped from January 18, 1997 through May 30, 1997.
MANUFACTURER Bar-Ray Products, Inc., Littlestown, Pennsylvania.
RECALLED BY Manufacturer, by letter dated July 11, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON The personnel and patient protection devices were manufactured from components
contaminated with radioactive materials.
_______________
PRODUCT Sterile Disposable Non-Invasive Blood Pressure Cuffs: a) Small Medium and
Large Adult
b) Neonatal (4 sizes). Recall #Z-849/850-7.
CODE Adult: M1808A (small = 10.5 cm)
M1809A (Adult = 14.0 cm)
M1829A (Lg. Adult = 17 cm)
Neonatal M1867A (Size 1 = 3.3-5.7 cm)
M1869A (Size 2 = 4.3-8.0 cm)
M1871A (Size 3 = 5.8-10.9 cm)
M1873A (Size 4 = 7.1 - 13.1 cm)
Devices shipped from January 1994-May 1997.
MANUFACTURER Gregory Manufacturing Inc., Holyoke, Massachusetts (OEM supplier).
RECALLED BY Hewlett Packard Company, Medical Products Group, Andover,
Massachusetts, by letter on July 3, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,852 cases were distributed.
REASON There is a defect in seal integrity that may compromise sterility of the device.
_______________
PRODUCT Assurance Monitors: a) Assurance A-2000H Hospital Monitor; b) Assurance
A-2000 Heart/Respiration Monitor.
Recall #Z-851/852-7.
CODE a) Serial Nos. 30052, 30092, 30233, 30301, 33437, 11935622 - 11938037 (not
consecutive);
b) Serial Nos. 8074, 8082, 8155, 8291, 8449, 8688, 8711, 8834-8958 (not consecutive).
MANUFACTURER Nellcor Puritan Bennett, Inc., Eden Prairie, Minnesota.
RECALLED BY Manufacturer, by telephone on July 3, 1997, followed by letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Hong Kong, Canada, Australia.
QUANTITY a) 54 units; b) 1,310 units were distributed.
REASON Contaminated circuit boards cause the units to malfunction, causing them to go
into continuous ECG Alarm or fail to detect apnea.
-14-_______________
PRODUCT Consensus Hip System Bipolar Head, CoCr, 45mm, for joint replacement. Recall
#Z-858-7.
CODE Lot No. 420026, Catalog No. 1014-0-0045.
MANUFACTURER U.S. Medical Products, Inc., Austin, Texas.
RECALLED BY Manufacturer, by letter on July 11, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Pennsylvania and Oklahoma.
QUANTITY 14 units were distributed.
REASON An incorrect assembly in at least two units of the lot, the presence of which would
allow macro motion between the bipolar head and the bipolar insert.
_______________
UPDATE Recall Z-431/432-7, InstaTrak Straight and Frontal Aspirators, Catalog Nos.
ENT-100AS-01 and ENT-101AF-01, manufactured by Visualization
Technology, Inc., Woburn, Massachusetts, which appeared in the April 23, 1997
Enforcement Report, reason is being amended to include the firms issuance of a
second letter, dated June 5, 1997, requesting the return of all affected devices,
due to GMP compliance problems.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Dial Brand Acid Concentrate for Bicarbonate Dialysis Product #AC-1052. Recall
#Z-799-7.
CODE Lot numbers: 631703C, 631703D, 635801D.
MANUFACTURER Gambro Healthcare, Deland, Florida.
RECALLED BY Manufacturer, by letter dated April 30, 1997. Firm-initiated recall
complete.
DISTRIBUTION Missouri, california, Maine.
QUANTITY 74 1-gallon cases were distributed.
REASON The dialysate values stated in Gm/L on the label of both one gallon and 55 gallon
containers are incorrect.
_______________
PRODUCT Monitor/Defibrillator/Pacemaker and Monitor/Defibrillator, used to convert
fibrillation to sinus rhythms capable of producing hemodynamically significant
heart beats: a) Model No. PD1200, Monitor/Defibrillator/ Pacemaker;
b) Model No. D900, Monitor/Defibrillator. Recall #Z-816/817-7.
-15-CODE Serial No. LISTING
a)7030 B96F11407 B97A12034 B97B12072
B97B12118
7321 B96J11810 B97A12035 B97B12073
B97B12119
7355 B97A11995 B97A12036 B97B12074
B97B12120
7425 B97A12000 B97A12037 B97B12075
B97B12121
7429 B97A12002 B97A12038 B97B12076
B97B12122
7450 B97A12003 B97A12039 B97B12077
B97B12123
7523 B97A12004 B97A12040 B97B12078
B97B12124
7608 B97Al2OO5 B97A12041 B97B12079
B97C12138
7764 B97A12006 B97A12042 B97B12080
B97C12155
7789 B97A12007 B97A12043 B97B12081
B97C12156
7963 B97A12008 B97A12044 B97B12082
B97C12157
8148 B97A12009 B97A12045 B97B12083
B97C12158
8300 B97A12010 B97A12046 B97B12094
B97C12159
8426 B97A12011 B97A12047 B97B12085
B97C12160
8720 B97A12012 B97A12048 B97B12086
B97C12162
8769 B97A12013 B97A12049 B97B12087
B97C12163
8857 B97A12014 B97A12050 B97B12088
B97C12178
8968 B97A12015 B97A12051 B97B12089
B97D12198
9186 B97A12016 B97A12052 B97B12090
9300 B97A12017 B97A12053 B97B12091
9324 B97A12018 B97A12054 B97B12092
9495 B97A12019 B97A12055 B97B12093
9869 B97A12021 B97A12056 B97B12094
9935 B97A12022 B97A12057 B97B12095
10347 B97A12023 B97A12058 B97B12097
10364 B97A12024 B97A12059 B97B12098
10430 B97A12025 B97B12060 B97B12102
B95J10696 B97A12026 B97B12061
B97B12108 B95K10808 B97A12027
B97B12063 B97B12109 B95LI0925
B97A12028 B97B12064 B97B12110
B96C11225 B97A12029 B97B12066
B97B12111 B96C11237 B97A12030
-16- B97B12068 B97B12112 B96E11357
B97A12031 B97B12070 B97B12116
B96F11368 B97A12033 B97B12071
B97B12117
b) 3177 C97AO4423 C97AO4429 C97BO4437
C97CO4451
3416 C97AO4424 C97AO4430 C97BO4438
C97CO4457
3595 C97AO4425 C97AO4431 C97BO4442
C97CO4458 C96104370 C97AO4426
C97AO4432 C97CO4448 C97CO4459
C97AO4421 C97AO4427 C97AO4433
C97CO4449 C97AO4422 C97AO4428
C97AO4434 C97CO4450.
MANUFACTURER Zoll Medical Corporation, Burlington, Massachusetts.
RECALLED BY Manufacturer, by letter on May 23, 1997. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY a) 154 units; b) 28 units were distributed.
REASON The devices do not display the alarm off indicator (bell symbol).
_______________
PRODUCT SeraChem Control Level 2, Serum Chemistry (human) and SeraChem Clinical
Chemistry Control Serum Level 2, used as a control for monitoring the accuracy
and precision of automated clinical chemistry methods performed by the IL
Monarch instrument:
a) SeraChem Control Level 2, Serum Chemistry (human), Catalog #181625-12
b) SeraChem Clinical Chemistry Control Serum Level 2, Catalog #2907-63.
Recall #Z-822/823-7.
CODE a) Lot N1064964; b) Lot N1065001.
MANUFACTURER Instrumentation Laboratory Company, Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company, Lexington, Massachusetts, by letter
dated July 16, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Japan, Hong Kong, Mexico, Canada.
QUANTITY a) 8 units; b) 393 units were distributed.
REASON The value listed on the insert sheet for creatine phosphokinase was incorrectly
printed as 252 U/L instead of 352 U/L.
_______________
PRODUCT Rigid Gas Permeable Daily Wear Contact Lenses, Polycon II, Silafocon A. Recall
#Z-826-7.
CODE LEHIU.
MANUFACTURER Wesley Jessen Corporation/PBH, San Diego, California.
-17-RECALLED BY Manufacturer, by telephone followed by letter on April 25, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 54 lenses were distributed.
REASON Some Contact Lenses were labeled with incorrect diopter values that did not
reflect the measured value of the product.
_______________
PRODUCT Surgical Lights: a) PRISMATIC Surgical Lights; b) ANGENIEUX Surgical
Lights.
Recall #Z-836/837-7.
CODE All codes.
MANUFACTURER ALM Equipments Hospitaliers, Le Pre-Saint-Gervals, France.
RECALLED BY ALM Surgical Equipment, Anaheim, California, by letter sent on June 27,
1997. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY a) 7,505 lights; b) 606 lights were distributed.
REASON Device label fails to declare the name and address of the manufacturer or
distributor as required by the Federal Food, Drug and Cosmetic Act.
_______________
PRODUCT Anesthesia Gas and Power Delivery Systems:
a) Model DVE4000 Series; b) Model DVE8000 Series. Recall #Z-847/848-7.
CODE All codes.
MANUFACTURER Dragerwerk Lubeck, Germany.
RECALLED BY ALM Surgical Equipment, Anaheim, California, by letter on April 29,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 250 units were distributed.
REASON Label fails to declare the name and address of the manufacturer or distributor as
required by the Federal Food, Drug and Cosmetic Act.
_______________
PRODUCT Kodak Diagnostic X-Ray Films:
a) T-MAT G/RA Film:
CAT. # SIZE QUANTITY per box
137 3125 35 x 43 cm 100 sheets
151 0023 24 x 30 cm 100 sheets
151 7473 24 x 24 cm 100 sheets
151 7887 30 x 35 cm 100 sheets
175 6196 8 x 10 in 100 sheets
830 1905 35 x 35 cm 100 sheets
174 6049 14 x 36 in 100 sheets
-18- 167 3805 8 x 10 in 500 sheets.
b) T-MAT L/RA Film:
CAT. # SIZE QUANTITY per box
121 9849 35 x 35 cm 100 sheets
170 9039 24 x 30 cm 100 sheets
179 9980 30 x 35 cm 100 sheets
181 4631 35 x 43 cm 100 sheets
819 0316 35 x 43 cm 300 sheets
831 0286 18 x 43 cm 100 sheets
840 7710 8 x 10 in 100 sheets
840 8858 24 x 24 cm 100 sheets
841 0789 18 x 24 cm 100 sheets
844 7054 11 x 14 in 100 sheets
807 0997 18 x 24 cm 100 sheets
842 7825 10 x 12 in 100 sheets
c) T-MAT S/RA Film:
CAT. # SIZE QUANTITY per box
124 7063 35 x 43 cm 100 sheets
151 7564 35 x 35 cm 100 sheets
191 3094 10 x 12 in 100 sheets
804 8365 24 x 24 cm 100 sheets
805 1419 8 x 10 in 100 sheets
806 3604 18 x 43 cm 100 sheets
809 2421 12 x 15 in 100 sheets
834 1422 24 x 30 cm 100 sheets
198 7122 35 x 43 cm 500 sheets
199 0217 14 x 36 in 25 sheets
136 2847 30 x 35 cm 500 sheets
155 6794 24 x 30 cm 500 sheets
189 7636 18 x 24 cm 500 sheets
d) ClinicSelect CSG/1 Film:
CAT. # SIZE QUANTITY per box
834 7098 18 x 24 cm 100 sheets
863 8041 35 x 43 cm 100 sheets
893 1537 24 x 30 cm 100 sheets
899 9245 8 x 10 in 100 sheets
e) Min-R 00 Film:
CAT. # SIZE QUANTITY per box
812 6393 24 x 30 cm 100 sheets
838 7441 18 x 24 cm 100 sheets.
Recall #Z-853/857-7.
CODE Emulsion Roll Numbers: 567 emulsion roll numbers. All emulsion roll numbers subject to
recall have EXP. DATES of "1999-06".
MANUFACTURER Eastman Kodak Company, Windsor, Colorado.
RECALLED BY Eastman Kodak Company, Rochester, New York, by letter on July 10, 15,
and 17, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 35,418 sales units were distributed.
-19-REASON The firm found a small quantity of the subject products could exhibit straight bands
of safelight fog due to operator error during the sensitized coating operation.
-20-
END OF ENFORCEMENT REPORT FOR AUGUST 20, 1997. BLANK PAGES MAY FOLLOW.
####
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