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.

ENFORCE
04/28/1993

Recalls and Field Corrections: Foods -- Class II -- 04/28/1993

APRIL 28, 1993 93-17

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________
PRODUCT Tiffany and Co. Exclusive Dinnerware, handpainted in Fran,
private stock ceramic dinnerware as follows:
(a) Escalier Pattern;
(b) Couer Fleur Pattern;
(c) Carousel Pattern;
(d) Kensington Pattern;
(e) Halcyon Pattern. Recall #F-296/300-3.
CODE All lots.
MANUFACTURER Le Tallec, Paris, France.
RECALLED BY Tiffany and Company, New York, by letter January 27, 1993,
followed by telephone on or about February 3, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON The product contains excessive levels of leachable lead.

PRODUCT Nutrasweet brand Aspartame Sweetener, in bulk drums, non-
nutritive sweetener for further manufacture.
Recall #F-307-3.
CODE Lot numbers: U30227, U30228, U30301, U30302, U30303,
U30304, U30305, U30306, U30307, U30308, U30309.
MANUFACTURER The NutraSweet Company, University Park, Illinois.
RECALLED BY The NutraSweet Company, Deerfield, Illinois, by telephone
March 24, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Barbados, Honduras, South Africa, Mexico,
Trinidad, Panama.
QUANTITY 56,775 kg was distributed; firm estimates 30 percent of the
product remains on the market.
REASON Product is contaminated with stainless steel metal
fragments.

_______________
PRODUCT Haagen-Dazs Extraas brand Triple Brownie Overload,
chocolate ice cream with brownies, Fudge Chunks and Pecans
Flavor Ice Cream. Recall #F-308-3.
CODE Best before 11 Sept. 93 DE 1927.
MANUFACTURER The Haagen Dazs Company, Inc., Woodbridge, New Jersey.
RECALLED BY The Hazagen Dazs Company, Fairfield, New Jersey, by
telephone September 26, 1992, followed by fax. Firm-
initiated recall complete.
DISTRIBUTION Connecticut, Florida, Illinois, Maryland, Massachusetts,
Minnesota, New Jersey, New York, North Carolina, Virginia.
QUANTITY 46,820 pints were distributed.
REASON Product contains almonds instead of labeled pecans.

_______________
PRODUCT Family brand Mandarin Orange Segments, in light syrup, in
11 ounce cans. Recall #F-309-3.
CODE All codes with P20 on top line.
MANUFACTURER Food Finned Factory, Hunan, People's Republic of China
RECALLED BY Family Food Company, Inc., Honolulu, Hawaii, by telephone
December 29, 1992. State of Hawaii Department of Health
issued a press release on January 8, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Hawaii.
QUANTITY Approximately 1,000 cartons (24 cans per carton) were
distributed.
REASON The product contains excessive levels of lead.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________
PRODUCT Ocean Spray Products, in 64 fluid ounce plastic bottles:
(a) Cranberry Juice Cocktail;
(b) Cranapple Juice; (c) Cran-Grape Juice;
(d) Cran-Raspberry Juice;
(e) Cran-Strawberry Juice. Recall #F-301/305-3.

-2-CODE All production with codes of A01113- through and including
A01153-, representing production between 1/11/93 through
1/15/93.
MANUFACTURER Whitfield Foods, Inc., Montgomery, Alabama.
RECALLED BY Ocean Spray Cranberries, Inc., Lakeville-Middlebboro,
Massachusetts, by letter. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Georgia, Illinois, Kentucky, Michigan,
Mississippi, Ohio.
QUANTITY (a) 148,576 bottles; (b) 73,792 bottles; (c) 67,584
bottles; (d) 40,848 bottles; (e) 31,144 bottles were
distributed.
REASON Product is contaminated with mold.

_______________
PRODUCT Infant's Choice Water, Calcium and Fluoride Added, Sodium
Free, in 1 gallon plastic jugs. Recall #F-306-3.
CODE All lots.
MANUFACTURER Magnetic Springs Water Company, Columbus, Ohio.
RECALLED BY Manufacturer, by letter March 18, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Ohio.
QUANTITY 24,000 gallons were distributed; firm estimates 2,000 to
3,000 gallons remain on the market.
REASON Product is mislabeled.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________
PRODUCT Quinidine Gluconate Extended Release Tablets, 324 mg, a Rx
anti-arrhythmic, under the following labels and numbers per
bottle:
Blue Cross -- 100, 250, 500, 1,000;
H.L. Moore -- 100, 250, 500,
Rugby -- 100, 100, 250, 500,
Aligen -- 100 & 250;
Harber -- 100, 250, 500,
Mason -- 100, 500,
Para-Med --100, 250, 500, 1,000;
Major -- 100, 250, 500,
Interstate Drug Exchange -- 250;
Purepac -- 100, 250;
Warner Chilcott -- 100;
Qualitest Products -- 100, 500;
Goldline -- 100, 250, 500. Recall #D-231-3.
CODE All lots within expiration date.
MANUFACTURER Halsey Drug Company, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by telephone March 12, 1993, followed by
letters of March 19 and 22, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.

-3-
QUANTITY Approximately 102.2 million tablets were distributed; firm
estimates no greater than 3 percent remain on the market.
REASON Use of unapproved inactive ingredients.

________________
PRODUCT Bumex (Bumetanide) Tablets, physician sample packages, all
dosage strengths, 0.5 mg, 1 mg, and 2 mg tablets, in 2 unit
blister pack card. Recall #D-238/240-3.
CODE All in-date lots.
MANUFACTURER Roche Laboratories, division of Hoffmann-LaRoche
Laboratories, Inc., Nutley, New Jersey.
RECALLED BY Manufacturer, by letters of December 7, 8, and 15, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 51,483 cartons of 10 cards (1x2);
(b) 113,369 cartons of 10 cards (1x2);
(c) 25,419 cartons of 10 cards (1x2); firm estimates
450,000 cartons of 10 cards remain on the market.
REASON Some blister cavities contained two tablets instead of one.

_______________
PRODUCT Nifedipine Softgel Capsules, USP, 10 mg, packaged in unit
dose cartons of 100 capsules, an oral Rx drug used for the
management of vasospastic angina and chronic stable angina.
Recall #D-241-3.
CODE Lot numbers: 1K933, 1K922, 1K917, 1I771, 1I760, 1I709,
1H638.
MANUFACTURER Chase Laboratories, Inc., Rockford, Illinois.
RECALLED BY UDL Laboratories, Rockford, Illinois, by telephone
September 19, 1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 40,897 unit dose cartons were distributed.
REASON Lack of assurance that product meets dissolution
specifications.

_______________
PRODUCT Methotrexate Film Coated Tablets, 2.5 mg, in bottles of 36
and 100, Rx used in treatment of cancer. Recall #D-242-3.
CODE Lot numbers: 1C572BD, 1C572BE EXP 7/93.
MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY Manufacturer, by letter April 12, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,976 36-tablet bottles, 1,568 100-tablet bottles of lot
1C572BD and; 2,588 100-tablet bottles of lot 1C572BE were
distributed.
REASON Subpotency.

-4-_______________
UPDATE Dilantin (Extended Phenytoin Sodium Capsules, USP)
Kapseals, 100 mg, Recall #D-191-3, which appeared in the
April 7, 1993 Enforcement Report has been extended to
include the following lot numbers:
09022 FA, 07681 FA, 07781 FA.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________
PRODUCT Bulk Sodium Phosphate Monobasic USP Monohydrate Granular
Tac, a pharmaceutical chemical, in 100 pound drums.
Recall #D-230-3.
CODE Lot numbers: SJK010 through SJK015, SJL016 through SJL019,
SJM024 through SJL023, SJM024 through SJM026, SJM032.
MANUFACTURER Mallinckrodt Specialty Chemicals Company, St. Louis,
Missouri.
RECALLED BY Manufacturer, by letter February 10, 1993. Firm-initiated
recall complete.
DISTRIBUTION 15 domestic consignees, Canada, Guatemala.
QUANTITY 66,950 pounds were distributed.
REASON Some lots may fail USP specifications for pH.

_______________
PRODUCT Anti-Tussive Cough Formula with DM, packaged under the Stop
N Shop label, in 8 ounce bottles. Recall #D-232-3.
CODE Lot numbers: L1203FA EXP 11/94, M1055FA EXP 12/94, M1074FB
EXP 12/94.
MANUFACTURER Pennex Products Company, Inc., Verona, Pennsylvania.
RECALLED BY Manufacturer, by letter January 20, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Connecticut.
QUANTITY 479 dozen bottles were distributed; firm estimates 80 to 85
percent of product distributed remains on the market.
REASON Label misprint -- Alcohol content declared as 14% instead
of 1.4%. Carton is correct.

_______________
PRODUCT OTC products: (a) Trimaphen Expetorant Yellow, under Good
Health label; (b) Anti-Tussive DM, cough Syrup, under The
Legend, Good Health, Stop N Shop, and Roval labels; (c)
Calohist Lotion, under Treasury, and Good Health labels.
Recall #D-233/235-3.
CODE Lot numbers: (a) G1216FA EXP 7/95; (b) G1203FA EXP 7/94,
G1203FB; (c) H1017FA, H1017FB EXP 8/95.
MANUFACTURER Pennex Products Company, Inc., Verona, Pennsylvania.
RECALLED BY Manufacturer, by letter March 10, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION (a) California, Texas, Ohio, Utah, Florida, New York,
Virginia, Illinois, Lebanon;

-5-
(b) Florida, Massachusetts, New Jersey, New York,
Tennessee, Illinois, Indiana, Ohio;
(c) Illinois, Virginia, Florida, Michigan, New Jersey,
Pennsylvania, Wisconsin, Louisiana, Kentucky, West
Virginia, West Virginia, New York, Trinidad, Hong Kong,
Dominican Republic.
QUANTITY Approximately (a) 230 dozen; (b) 188 dozen; (c) 300 dozen
bottles were distributed.
REASON (a & b) Alcohol ingredient fails stability specifications;
(c) Subpotency.

_______________
PRODUCT Phenazopyridine Hydrochloride Tablets, USP, in unit dose
cartons of 100, and in bottles of 100: (a) 100 mg;
(b) 200 mg, an oral Rx drug indicated for the symptomatic
relief of pain burning, urgency, frequency and other
discomforts arising from irritation of the lower urinary
tract mucosa. Recall #D-236/237-3.
CODE Lot numbers: (a) 1S262, 2C703, 2I989 (unit dose)
91171, 91210 (bottles of 100);
(b) 1P152 2A469, 2F834 (unit dose), 91212, 92037 (bottles
of 100).
MANUFACTURER Amide Pharmaceuticals, Little Falls, New Jersey.
RECALLED BY UDL Laboratories, Rockford, Illinois, by letter September
1, 1992, October 14, 1992 and December 18, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 13,258 unit dose cartons and 2,640 100-tablet bottles;
(b) 9,604 unit dose cartons and 2,260 100-tablet bottles
were distributed; firm estimates 30 percent of the product
remains on the market.
REASON Products do not meet dissolution specifications.

_______________
PRODUCT Hydrocodone Bitartrate and Acetaminophen Tablets, 5 mg/500
mg, Rx for the relief of moderate to moderately severe
pain, packaged under the following labels:
Duradyne DHC, in 100 and 1,000 tablet bottles;
Anodynos DHC, in 100 tablet bottles. Recall #D-243-3.
CODE 19044.
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., Maryland Heights, Missouri,
by telephone beginning March 3, 1992 through approximately
March 10, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide
QUANTITY Duradyne DHC -- 3,282 bottles of 100 and 195 bottles of
1,000; Anodynos DHC -- 96 bottles of 100 were distributed.
REASON Product had an incorrect expiration date of 3/93 instead of
3/92.

-6-_______________
PRODUCT Dramamine brand Dimenhydrinate 50 mg antiemetic tablets,
packaged in 36 ounce blister strip in carton.
Recall #D-244-3.
CODE Lot numbers: 519JP EXP 9/30/94, 294JW EXP 10/31/94; 295JW
EXP 10/31/94.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter April 14, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 123,368 cartons were distributed.
REASON Incorrect declaration of inactive ingredients.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________
PRODUCT Recovered Plasma. Recall #B-150-3.
CODE Unit numbers: 2712632, 2712633, 2712634, 2712635, 2712636,
2712637, 2712638, 2712639, 2712642, 2712643, 2712644,
2712669, 2712671, 2712672, 2712674, 2793144, 2793145,
2793146, 2793148, 2793150, 2793151, 2793152, 2793153,
2793154, 2793155, 2793157, 2793159.
MANUFACTURER Department of the Army Brooke Army Medical Center, Fort Sam
Houston, Texas.
RECALLED BY Manufacturer, by letter November 9, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 27 units.
REASON Blood products, which tested non-reactive for the antibody
to hepatitis C virus (anti-HCV) using the single antigen
test kit, but were not tested by the licensed anti-HCV
multi-antigen test kit, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-224/225-3.
CODE Unit #2211767.
MANUFACTURER Department of the Army, U.S. Army Medical Department
Activity, T/A Frank R. Camp Memorial Blood Center, Fort
Knox, Kentucky.
RECALLED BY Manufacturer, by letter November 20, 1992. Firm-initiated
recall complete.
DISTRIBUTION Missouri, Florida.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for all required or
recommended tests but were collected from a donor who
previously participated in high risk behavior, were
distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-233-3.
CODE Unit #29FP06014.

-7-MANUFACTURER American Red Cross Services, Norfolk, Virginia.
RECALLED BY Manufacturer, by telephone November 2, 1991. Firm-
initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit.
REASON Blood product, with the incorrect expiration date was
distributed.

_______________
PRODUCT Platelets. Recall #B-234-3.
CODE Unit #7148188.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone followed by letter on July 27,
1992. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, collected from an ineligible donor due to a
history of white spots or unusual blemishes in the mouth, a
symptom of infection with the human immunodeficiency virus
type 1 (HIV-1), was distributed.

_______________
PRODUCT Plasma, Platelets Poor. Recall #B-235-3.
CODE Unit #SG012548.
MANUFACTURER Biological Specialty Corporation, Lansdale, Pennsylvania.
RECALLED BY Manufacturer, by telephone November 20, 1992, followed by
letter November 23, 1992. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV),
was not retested in duplicate as required and was
distributed for further manufacture into non-injectable
products incorrectly labeled as anti-HCV negative.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-151/152-3.
CODE Unit numbers: (a) 2793052; (b) 2712593, 2712598, 2712614,
2793089, 2793104.
MANUFACTURER Department of the Army, Brooke Army Medical Center, Fort
Sam Houston, Texas.
RECALLED BY Manufacturer, by letter dated September 23 1992 and July
31, 1992. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY (a) 1 unit; (b) 5 units.
REASON Blood products, which tested non-reactive for the antibody
to hepatitis C virus (anti-HCV) using the single antigen
test kit, but were not tested by the licensed anti-HCV
multi-antigen test kit, were distributed.

-8-_______________
PRODUCT Recovered Plasma. Recall #B-217-3.
CODE 92-0552, 92-0569, 92-0573, 92-0574, 92-0588, 92-0592,
92-0593, 92-0597, 92-0604, 92-0612, 92-0613, 92-0614,
92-0616, 92-0622, 92-0623, 92-0630, 92-0634, 92-0639,
92-0648, 92-0672, 92-0679, 92-0699.
MANUFACTURER Davis Memorial Hospital, Elkins, West Virginia.
RECALLED BY Manufacturer, by letter November 5, 1992. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 22 units were distributed.
REASON Blood products, tested for the antibody to hepatitis C
virus (anti-HCV) with the multi-antigen test kit in a
manner inconsistent with the manufacturer's test kit
instructions, were distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-222-3.
CODE Unit #22-08511.
MANUFACTURER Itasca Medical Center Blood Bank, Grand Rapids, Minnesota.
RECALLED BY Manufacturer, by telephone January 28, 1993, and by letter
February 8, 1993. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 Unit.
REASON Recovered Plasma, which tested initially reactive for the
hepatitis B surface antigen (HBsAg), was distributed.

RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS II
_______________
PRODUCT Select Shoulder System Glenoid Component. This system is
designed to address anatomic considerations and
postoperative motion in total shoulder replacement and
hemiarthroplasty. Recall #Z-132-3.
CODE Catalog numbers Lot numbers
7501-00-002 51834 (medium)
7501-00-003 51835 (large).
MANUFACTURER Intermedics Orthopedics, Inc., Austin, Texas.
RECALLED BY Manufacturer, by fax on September 10, 1992. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Switzerland.
QUANTITY 30 components were distributed. All returned units have
been reconditioned by relabeling and repackaging.
REASON Products were labeled with incorrect sizes, medium size
labeled as large.

_______________
PRODUCT Diameter Check Option for the DM Series of Drilling
Machines. Recall #Z-468-3.
CODE Serial numbers: Undetermined.
MANUFACTURER Dynamotion Corporation, Santa Ana, California.

-9-RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan March 29, 1993. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide.
QUANTITY 8 units were distributed.
REASON Noncompliance with the performance standards for laser
products in that the interlock failed to have indication of
defeat, products contain incorrect protective housing
label, lack of certification labels, and the user manuals
lacked required information.

_______________
PRODUCT Axial Lead Component Inserter, DIP Component Inserter, and
High-Speed Chip Placer, Models V12000, DD4500, and I2200.
Recall #Z-469-3.
CODE Serial numbers: None.
MANUFACTURER Dynapert, Inc., Beverly, Massachusetts.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan March 29, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 58 units were distributed.
REASON Noncompliance with the performance standards for laser
products in that initial or model change reports had not
been submitted for the above referenced products.

_______________
PRODUCT Oscillating saw blades, sterile, single-use devices
intended for use with powered surgical instruments for
reconstructive and traumatic bone surgery, as follows:
Catalog #2000-00-105 - 1" (STRYKER FIT)
Catalog #2000-00-106 - 1" CAP (STRYKER FIT)
Catalog #2000-00-150 - 1/2" (STRYKER FIT)
Catalog #2000-00-151 - 1/2" CAP (STRYKER FIT)
Catalog #2000-01-150 - 1/2" (3M FIT)
Catalog #2000-01-200 - 1" (3M FIT)
Catalog #2000-02-111 - 1" (ZIMMER FIT)
Catalog #2000-02-151 - 1/2" (ZIMMER FIT)
Catalog #2000-99-100 - 1/2" AESCULAP
Catalog #2000-99-101 - 1" AESCULAP
Catalog #2000-99-105 - 1" (3M FIT) INTL
Catalog #2000-99-150 - 1/2" A.O. SYNTHES, Recall #Z-484-3.
CODES All oscillating saw blades manufactured by Betzler
Manufacturing, El Monte, CA distributed June 24, 1992 to
January 21, 1993.
Note: Labels of the recalled blades are blank in the lower
left-hand corner. Labels of blades not involved in the
recall indicate in the lower left-hand corner that the
blades were manufactured by Micro-Aire Surgical
Instruments, Inc., Valencia, California.
MANUFACTURER Betzler Manufacturing, El Monte, California (blade).

-10-RECALLED BY Intermedics Orthopedics, Inc. (IOI), Austin, Texas, by
letter January 21 and 29, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Switzerland, Canada.
QUANTITY 5,111 blades were distributed.
REASON Failure of the saw blades to meet hardness specification
resulted in dull blades.

_______________
PRODUCT Photon ERA Software, Versions 3.8M, 3.8 MD, 4.01 and ERA-QA
1.01, used in the Photon ERA Automated Immunoassay
Analyzer. Recall #Z-470-3.
CODE Model: Photon ERA-QA, part/catalog #20100001 - All serial
numbers; Software Version 1.01, Disk Set Catalog #20135002;
System Disk Catalog #20113002, all lot numbers.
Model: Photon ERA, part/catalog #9R1001 and 998000, all
serial numbers and with 3 associated software versions.
Software version 4.01, Disk Set Catalog #20110002; System
Disk Catalog #20107002, all lot numbers. Software version
3.8 MD, disk set catalog #2056; system disk catalog
#998087, all lot numbers. Software version 3.8M, disk set
catalog #2055, system disk catalog #998097, all lot
numbers.
MANUFACTURER Hybritech, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter on or about February 5, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 663 units were distributed.
REASON There are three software problems, which, in some cases,
could lead to incorrect calculation of patient results on
photon ERA assays.

_______________
PRODUCT Redi-Pak Sterile Exodontia Sponges, a cotton-filled 2 x 2
sterile exodontia sponge contained in a heat sealed paper
pouch. Recall #Z-477-3.
CODE Product code 300404, lot #R2M024.
MANUFACTURER Richmond Dental Cotton Company, a subsidiary of Barnhart
Manufacturing Company, Inc., Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone followed by letter February 5,
1993. Firm-initiated recall complete.
DISTRIBUTION Maryland, Massachusetts, Georgia.
QUANTITY 35 cases were distributed.
REASON The sterility of the device may have been compromised due
to packaging wrinkles and leaks.

_______________
PRODUCT Invivo brand Oxi-Clip Finger Probe, Model 9383 Adult Site,
an accessory to the Invivo brand Pulse Oximeter which
monitors the patient's pulse rate and blood oxygen
saturation. Recall #Z-478-3.

-11-CODE Serial numbers F-01421 through F01514 and F03746 through
F04083.
MANUFACTURER Invivo Research, Inc., Orlando, Florida
RECALLED BY Manufacturer, by letter January 12, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 267 units were distributed.
REASON A problem with signal cross-talk may result in erroneous
saturated oxygen levels.

_______________
PRODUCT Coburn Intraocular Lens, Models (a) 62; (b) 62N; (c) 72;
(d) 72N; (e) 120UV. Recall #Z-479/483-3.
CODE Control numbers: (a) J24037; (b) 103421; (c) 135316;
(d) 137815, J31033, 126903, 135316, 136205, 136227; (e)
102133,102143, 109005, 109931, 109933.
MANUFACTURER Storz Ophthalmics, Inc., Clearwater, Florida.
RECALLED BY fax or overnight courier December 23, 1992, followed by
telephone December 31, 1992. Firm-initiated recall
complete.
DISTRIBUTION South Carolina, Tennessee, Kentucky, California, Texas, New
York, Iowa, New York, Florida, Michigan.
QUANTITY 54 units were distributed.
REASON Rejected lenses of the incorrect diopter and size may have
been labeled incorrectly.

________________
PRODUCT Posi-Shield Latex Exam Gloves, Small Size, 100 per box.
Recall #Z-485-3.
CODE Gloves shipped between 10/6/92 and 10/26/92.
MANUFACTURER West Chester Marketing, Inc., West Chester, Ohio.
RECALLED BY Manufacturer, by letter dated November 6, 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Michigan, Minnesota, Ohio, Tennessee, Georgia.
QUANTITY 803 boxes were distributed.
REASON The gloves contain more holes than allowed by FDA's
compliance policy guide.
_______________
PRODUCT Phoenix brand vinyl gloves:
(a) Medium Size, Catalog #PV602;
(b) Large Size, Catalog #PV603. Recall #Z-486/487-3.
CODE All lots sold between 7/1/92 and 10/1/92.
MANUFACTURER Miesse Nursing Home Supply, Columbus, Ohio.
RECALLED BY Manufacturer, by letter on or about November 18, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 1 bag; (b) 23 bags were distributed.
REASON The gloves labeled on the shipping cases as being for,
"non-Medical Use," were distributed to nursing homes for
medical use. However, the labeling on the individual bags
which were distributed, failed to indicate whether the
gloves were a medical or non medical grade.

-12-RECALLS AND FIELD CORRECTIONS: MEDICAL DEVICES -- CLASS III
_______________
PRODUCT DiaLyte Concentrate for Bicarbonate Dialysate, in plastic
gallon bottles, used in hemodialysis. Recall #Z-475-3.
CODE Lot numbers Dial Formula # Baxter Product No
01018685 BC-101 5M7709N
01018766 BC-101 5M7709N
01018811 BC-101 5M7709N.
MANUFACTURER Dial Medical of Florida, Inc., Deland, Florida.
RECALLED BY Manufacturer, by letter May 15, 1992. Firm-initiated
recall complete.
DISTRIBUTION Tennessee.
QUANTITY Firm estimates none remains on the market.
REASON Some containers of concentrate may be contaminated with
mold.

_______________
PRODUCT Nellcor N-250 Pulse Oximeter/ECG Monitor Manual.
Recall #Z-476-3.
CODE All serial numbers.
MANUFACTURER Nellcor, Inc., Hayward, California.
RECALLED BY Manufacturer, by ----------------. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 753 units were distributed; firm estimates 559 units remain
on the market.
REASON Product contains incorrect information regarding the
attachment of an external alarm.

INJUNCTION:
_______________
PRODUCT Various sterile medical devices (twist in ear tubes,
suction tubing, and nasal splints, etc.) (91-618-806).
CHARGE The complaint against the defendants charged that the
devices manufactured by them are adulterated in that the
methods used in, and the facilities and controls used for,
the devices' manufacture, packing, and storage are not in
conformity with the good manufacturing practice regulations
for devices. The complaint further charged that the
defendants introduced, and delivered for introduction into
interstate commerce, adulterated articles; and, that the
defendants had adulterated articles while the articles were
held for sale after the shipment of one or more of their
components in interstate commerce.
DEFENDANTS Anthony Products, Inc., and Charles R. Petrucciani,
Indianapolis, Indiana.
FILED April 6, 1993, Complaint; April 7, 1993, Consent Decree of
Permanent Injunction; U.S. District Court for the Southern
District of Indiana, Indianapolis Division;
Civ. #IP93-457C; INJ 1293.

-13-SEIZURES:
_______________
PRODUCT Canned Mandarin Oranges (92-556-382).
CHARGE Adulterated - The article is unfit for food because the
cans are swollen.
FIRM Grimes Distribution Services, Jacksonville, Florida.
FILED December 8, 1992; U.S. District Court for the Middle
District of Florida, Jacksonville Division; Civil
#92-1327-CIV-J-10, FDC #66635.
SEIZED December 10, 1992 - goods valued at approximately $60,000.

_______________
PRODUCT Porcelain food service articles (92-706-261).
CHARGE Adulterated - the articles contain lead, an unsafe food
additive.
FIRM Wing Sing Chong Company, Inc., San Francisco, California.
FILED February 5, 1993; U.S. District Court for the Northern
District of California; Civil #C93-0439-JPV, FDC #66651.
SEIZED February 12, 1993 - goods valued at approximately $6,618.

-14-

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