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
01/31/1996
ENFORCEMENT REPORT FOR 01/31/96
January 31, 1996 96-05
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ===========
_______________
PRODUCTS Ice Cream, Frozen Yogurt, Sherbet, Sorbet, and
Ice Cream Mix (bulk), all sizes, all flavors,
manufactured between August 1, 1995 and
October 18, 1995 packaged under seventeen (17)
different labels listed as follows:
ICE CREAM: Ice Cream, [1 pint size], packaged
under the labels: Royal Premium, Pierre's
French, and Heinen's French, and Parmalat.
Flavors: Black Cherry, Butter Pecan,
Cappuccino Chunk, Cherry Vanilla, Chocolate,
Choc. Malt Chip, Choc. Chip, Coconut Bar,
Cookie Dough, Spumoni, Strawberry, Vanilla,
Black Walnut, Cookie-Cream Vanilla,
Neapolitan, Coffee, Mint Choc. Chip,
Peppermint Stick, Tin Roof, Praline & Cream.
Ice Cream, [½ gallon size], packaged under the
labels: Pierre's French, Pierre's No Added
Sugar, Pierre's Fat Free, Pierre's Low Fat,
Royal Premium, Flavorful, Bi-Rite, Convenient,
Dave's, Eagle, Food Centre, Heinen's, Heinen's
French, Hillside, Marc's, Medic, Shoprite,
Simply Delicious, Parmalat, Russo's.
Flavors: Neapolitan, Choc. Pretzels & Cream, Black Walnut, Brownie Nut Sundae, Butter
Pecan, Choc. Chip, Cherry Vanilla, Chocolate,
Choc. Fudge Mousse, Choc. Malt Chip, Choc.
Almond, Cinnamon, Citrus Cooler, Coco-Pine,
Coffee, Cookie Dough, Cookie-Cream-Vanilla,
Double Fudge Brownie, Greatest Hit, Toffee
Crunch, Lemon Chiffon, Mint Choc. Chip, Mocha
Almond Fudge, Nutcracker Sweet, Orange Pine,
Peach & Cream, Peppermint Stick, Pistachio
Nut, Peanut Butter Cup, Praline Pecan, Pumpkin
Pie, Rocky Road, Rum-Raisin, Slam Dunk Chunk,
Spumoni, Strawberry, Strawberry Shortcake, Tin
Roof, Triple Play, Vanilla, Black Cherry,
Espresso & Cream, Bicentennial Brownie Blitz,
Cherries & Choc. Fudge, Fruit Salad, Carmel
Nut Crunch, Chocolate Trio, Peach Cobbler,
Sundae with Heath Pieces, Chocolate Parfait,
Vanilla Raspberry, Vanilla Orange, Golden
Vanilla, Peach, Chocolate Marshmallow,
Heavenly Hash, Strawberry Ripple,
Ice Cream, [5 quart pail size], packaged under
the label: Superscoop.
Flavors: Butterscotch Ripple, Chocolate,
Choc. Parfait, Cookie-Cream-Vanilla,
Neapolitan, Rainbow Burst, Vanilla, Vanilla
Orange.
Ice Cream, [3 gallon size], packaged under the
labels: Royal Premium, Pierre's French,
Pierre's No Added Sugar, Parmalat, Ardwin
Hayes.
Flavors: Neapolitan, Banana, Black Cherry,
Bubble Gum, Choc. Chunk, Cherry Vanilla,
Chocolate, Choc. Chip, Cinnamon, Citrus
Cooler, Coco-Pine, Coffee, Cookie Dough,
Cookie-Cream-Vanilla, Double Dark Chocolate,
Egg Nog, Toffee Crunch, Lemon Chiffon, Mint
Choc. Chip, Mississippi Mud, Peach & Cream,
Peppermint Stick, Peanut Butter Cup, Pumpkin
Pie, Rum-Raisin, Spumoni, Strawberry,
Strawberry Cheesecake, Superman, Triple Play,
Vanilla, Vanilla Bean, Bicentennial Brownie
Blitz, Cherries & Choc. Fudge, Toffee Sundae
with Heath Candy, Fudge Whirl, Peach, Carmel
Fudge, Choc. Marshmallow, French Vanilla,
Vanilla Fudge, Black Walnut, Brownie Nut
Sundae, Butter Pecan, Mocha Almond Fudge,
Pistachio Nut, Praline Pecan, Rocky Road, Tin
Roof, Praline & Cream.
YOGURT: Frozen Yogurt, [1 pint size],
packaged under the label: Pierre's No Added
Sugar.
-2- Flavors: Cherry Cordial, Choc. Almond, Tin
Roof, Chocolate, Cookie Dough, Strawberry,
Vanilla.
Frozen Yogurt, [½ gallon size], packaged under
the labels: Pierre's Soft, Pierre's Fat Free,
Heinen's, Parmalat.
Flavors: Butter Pecan, Carmel Pecan Fudge,
Choc. Chunk, Cherry Pie, Chocolate, Choc.
Peanut, Cookie Dough, Toffee Crunch, Peach,
Raspberry, Strawberry, Vanilla, Cherry
Vanilla, Choc. Malt Swirl, Coconut Bar, Lemon
Meringue Pie, Mocha Fudge, Rocky River,
Vanilla Fudge.
Frozen Yogurt, [3 gallon size], packaged under
the labels: Pierre's Soft, Pierre's Fat Free.
Flavors: Butter Pecan, Choc. Chip Chunk,
Chocolate, Toffee Crunch with Heath Candy,
Peach, Raspberry, Strawberry, Vanilla.
SHERBET: Sherbet, [1 quart size], packaged
under the labels: Pierre's and Parmalat.
Flavors: Cherry Lemon, Lemon, Orange,
Pineapple, Rainbow, Raspberry.
Sherbet, [3 gallon size], packaged under the
label: Pierre's.
Flavors: Lemon, Lime, Orange, Pineapple, Pink
Champagne, Rainbow, Raspberry.
SORBET: Sorbet, [3 gallon size], packaged
under the label: Pierre's.
Flavors: Lemon, Raspberry.
Ice Cream Mix, [bulk], is trucked only to
Frecker's Ice Cream Co. Recall #F-150/259.
CODES All codes between "95213" and "95291". The
code is embossed or stamped on the retail box.
No identification appears on the shipping
master cases.
MANUFACTURER Royal Ice Cream Company, doing business as
Pierre's French Ice Cream Company, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters and by press releases
on October 30, 1995, November 2 and 17, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Ohio, Indiana, Pennsylvania, Michigan,
Georgia, North Carolina, South Carolina,
Tennessee, Kentucky, Virginia.
QUANTITY Approximately 420,000 gallons were
distributed.
REASON Products are or may be contaminated with
Listeria monocytogenes.
_______________
PRODUCT Safeway Select Light Rocky Road Ice Cream, in
half gallon containers. Recall #F-268-6.
-3- CODE 031996.
MANUFACTURER Jerseymaid Dairies, Commerce, California.
RECALLED BY Safeway, Inc., Oakland, California, by sending
E-Mail messages beginning on December 1, 1995,
by press release on December 14, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION California, Arizona, Hawaii, New Mexico,
Nevada.
QUANTITY Approximately 1,010 cases were distributed;
firm estimates none remains on market.
REASON Product is contaminated with Listeria
monocytogenes.
_______________
PRODUCT Various Ice Cream in quart, 1/2 gallon, 5
quart pail and 3 gallon bulk tubs:
(a) Chocolate Ice Cream, Vanilla Ice Cream.
Recall #F-269/270-6.
CODE Date code: 5311, 5313, 5318, 5325, 5332.
MANUFACTURER Jilbert Dairy, Inc., Marquette, Michigan.
RECALLED BY Manufacturer, by press release December 18,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Michigan.
QUANTITY Undetermined.
REASON Product is contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Egg Bagels sold in bulk bins and occasionally
packaged with other flavors in four bagel
packs. Recall #F-148-6.
CODE All codes shipped prior to 5/3/95.
MANUFACTURER The Great American Bagel Company, Waukarusa,
Indiana.
RECALLED BY Manufacturer, by letter May 1, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 13,136 dozen were distributed; firm estimated
that 400 dozen remained on market at time of
recall initiation.
REASON Product contains undeclared FD&C Yellow No. 5
& 6.
_______________
PRODUCT Raisin Sweet Rolls, in 17.5 ounce packages in
clear plastic bags. Recall #F-149-6.
CODE All products with an expiration date on or
before Nov. 18, 1995.
MANUFACTURER John Pitta Baking Corporation, Newark, New
Jersey.
-4- RECALLED BY Manufacturer, by letter dated November 1,
1995. FDA/State-initiated recall complete.
DISTRIBUTION New Jersey and New York.
QUANTITY 6,800 packages were distributed.
REASON Product contained undeclared FD&C Yellow No. 5
and 6.
_______________
PRODUCT Various custom pieces of ceramicware for food
service manufactured with solid olive green
overglaze. Recall #F-261-6.
CODE No product coding used - "goehring" and "95"
or "94" written/engraved on bottom of pieces.
MANUFACTURER Square One International, Inc., Tampa,
Florida.
RECALLED BY Manufacturer, by letter mailed beginning on
December 5, 1995. FDA-initiated recall
complete.
DISTRIBUTION Oregon, Georgia, Minnesota, North Carolina,
Texas, Washington, Connecticut.
QUANTITY 15 pieces were distributed.
REASON Products contained excessive levels of
leachable lead.
_______________
PRODUCT Ceramicware-Luneville Strasbourg Pattern, Rose
Design and Tulip Design. Recall F-265/266-6.
CODE All lots.
MANUFACTURER Luneville, Paris, France.
RECALLED BY The Zrike Company, Inc., Pompton Plains, New
Jersey, by letter November 27, 1995. FDA-
initiated recall ongoing.
DISTRIBUTION Rhode Island, Virginia, New York, California,
Massachusetts, Florida.
QUANTITY 6,064 pieces were distributed.
REASON Product contains excessive levels of leachable
lead.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT La Sousa brand Seasoning:
(a) La Sosua Adobo Completo con o sin pimienta
(Complete Seasoning with & without pepper),
5.65 and 7.5 oz. plastic containers
(b) La Sosua Cebolla Picada (Chopped Onion),
1.23 and 2.33 oz. plastic containers
(c) La Sosua Ajo Picado (Chopped Garlic), 2.5
and 3.84 oz. plastic containers.
Recall #F-262-264-6.
CODE UPC Codes: (a) 59417-1, 59419-5 (with
pepper); 59418-8, 59420-1 (without pepper);
(b) 59405-8, 59409-6; (c) 59411-9, 59415-7.
-5- MANUFACTURER La Sosua Food Corporation, Fairview, New
Jersey.
RECALLED BY Manufacturer, by visit on or about June 1,
1995. Firm-initiated recall complete.
DISTRIBUTION New York and New Jersey.
QUANTITY 60,000 units were distributed.
REASON Product label fails to bear the identity of
the product and the ingredient statement in
English.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Levothyroxine Sodium Tablets, USP 0.025 mg in
bottles of 100 and 1,000, Rx drug indicated to
treat hypothyroidism, under the following
labels: MOVA Pharmaceutical, Pharmascience
Inc., Warner Chilcott, Duramed
Pharmaceuticals, H.I. Moore Drug Exchange,
Goldine Laboratories, Lederle Laboratories
Division. Recall #D-079-6.
CODE LOT # EXP. DATE LOT # EXP. DATE
MLT0222A 7/96 MLTO441C 9/96
MKT2132C 3/96 MKT2132B 3/96
MKT0221A 7/96 MLT0322A 9/96
MLT0441A 9/96
MKT2131A 3/96 MKT2132A 3/96
MLT0223A 7/96 MLT0321A 9/96
MLT0442A 9/96 MLT0441E 9/96
MLT4441A 4/97 MLT4442A 4/97
MLT0225A 7/97 MLTO444A 9/96
MLT0224A 7/96 MLT0443A 9/96
MLT1541A 1/97
398-124 9/96 388-132 3/96
MLT0441B MLT0441D.
MANUFACTURER MOVA Pharmaceutical Corporation, Caguas,
Puerto Rico.
RECALLED BY Manufacturer, by letter December 29, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 26,891 units were distributed; firm estimated
that 10,100 units remained on market at time
of recall initiation.
REASON Potency not assured through expiration date.
_______________
PRODUCT Ethex Nitroglycerin Extended-release Capsules,
6.5 mg, packaged in 100-capsule bottles, Rx
for the prevention of angina pectoris due to
coronary artery disease. Recall #D-081-6.
CODE Lot #V3112 EXP 5/97.
-6- MANUFACTURER KV Pharmaceutical Company, St. Louis,
Missouri.
RECALLED BY Ethex Corporation, St. Louis, Missouri, by
letter dated January 10, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,453 bottles were distributed.
REASON Product does not meet dissolution
specification.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Maalox Cherry Suspension, in 26 fluid ounce
bottles, for use as an antacid.
Recall #D-080-6.
CODE Lot #CN00123.
MANUFACTURER CIBA Self-Medication, Inc., Fort Washington,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated November 21,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 16,429 units of lot CN00123 were distributed.
REASON Product bears incorrect front panel label
which declares simethicone ingredient. Back
panel is correct.
_______________
PRODUCT Inulin and Sodium Chloride Injection, USP, in
50 ml vials, indicated for the measurement of
Glomerular Filtration Rate (GFR).
Recall #D-082-6.
CODE Lot #299505B EXP 6/30/96.
MANUFACTURER Ben Venue Laboratories, Inc., Bedford, Ohio.
RECALLED BY Cypros Pharmaceutical Corporation, Carlsbad,
California, by letter on December 13, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, South Africa, Spain.
QUANTITY 1,719 vials were distributed.
REASON Product does not meet stability
specifications.
_______________
UPDATE Hemorrhoidal HC 25 mg Suppositories, Recall
#D-043-6 which appeared in the December 27,
1995 Enforcement Report has been extended to
include three additional lot numbers:
A005 - 6,314 cartons were distributed;
A006 - 1,008 cartons were distributed;
A006A - 3,541 cartons were distributed.
-7- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells. Recall #B-146-6.
CODE Unit #21GH10866.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated June 14, 1994.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had
traveled to an area designated as endemic for
malaria, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma; (c)
Platelets. Recall #B-150/152-6.
CODE Unit numbers: (a) 04FJ56861, 04FK93084; (b)
04FJ56861, 04FK93084; (c) 04FK93084.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letters dated January 31,
1991. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, New York.
QUANTITY (a) 2 units; (b) 2 units; (c) 1 unit.
REASON Blood products, which were collected from a
donor with a previous history of hepatitis,
were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-157/159-6.
CODE Unit numbers: 8424912, 8449884.
MANUFACTURER The Blood Center for Southeast Louisiana, New
Orleans, Louisiana.
RECALLED BY Manufacturer, by letter dated February 21,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Louisiana, California.
QUANTITY 2 units of each component.
REASON Blood products, which were collected from a
donor with a medical history of hepatitis,
were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-161/163-6.
CODE Unit numbers: (a) 8432749, 8464037; (b)
8432749 (Salvaged), 8464037; (c) 8432749,
8464037.
MANUFACTURER The Blood Center for Southeast Louisiana, New
Orleans, Louisiana.
RECALLED BY Manufacturer, by letter dated August 17, 1994.
Firm-initiated recall ongoing.
-8- DISTRIBUTION Louisiana.
QUANTITY 2 units of each component.
REASON Blood products, which tested nonreactive for
the antibody to the hepatitis B core antigen
(anti-HBc), but were collected from a donor
who previously tested repeatedly reactive for
anti-HBc, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-164/166-6.
CODE Unit #8546377.
MANUFACTURER The Blood Center for Southeast Louisiana, New
Orleans, Louisiana.
RECALLED BY Manufacturer, by letters dated September 6,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Louisiana, California.
QUANTITY 1 unit of each component.
REASON Blood products, which were initially tested
from first generation anti-HCV kits were
negative. Second generation test kit sample
was not retested in duplicate, and found to be
initially reactive. Subsequent donations did
not identify the donor as deferred and
subsequent donations were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-167-6.
CODE Unit #4558812.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter dated August 30, 1995.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which was collected from a
donor who had visited an area designated as
endemic for malaria, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-181/182-6.
CODE Unit #25FR53321.
MANUFACTURER American Red Cross Blood Services, Syracuse,
New York.
RECALLED BY Manufacturer, by letters dated September 26,
1994. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a
donor who had visited an area endemic for
malaria, were distributed.
-9- _______________
PRODUCT Red Blood Cells. Recall #B-183-6.
CODE Unit #GP61402.
MANUFACTURER The Blood Center for Southeastern Wisconsin,
Milwaukee, Wisconsin.
RECALLED BY Manufacturer, by telephone on March 6, 1995.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit.
REASON Blood product, collected from a donor with a
previous history of hepatitis, was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-186/187-6.
CODE Unit numbers: (a) 21Y18855 and 21GM16233; (b)
21Y18855.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letters dated March 8, 1995.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY (a) 2 units; (b) 1 unit.
REASON Blood products, collected from a donor who had
lived in an area designated as endemic for
malaria, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Frozen Plasma. Recall #B-168-6.
CODE 04H85880, 04L08035, 04L08040, 04L08053,
04L08028, 04L08025.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letters dated January 15,
1991, and May 30, 1991. Firm-initiated recall
complete.
DISTRIBUTION California, Massachusetts.
QUANTITY 6 units.
REASON Blood products, corresponding to pooled
platelets, which were possibly contaminated
with Staphylococcus aureus, were distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-188-6.
CODE Unit #542087.
MANUFACTURER Belle Bonfils Memorial Blood Center, Denver,
Colorado.
RECALLED BY Manufacturer, by letter dated December 9,
1994. Firm-initiated recall complete.
DISTRIBUTION California.
-10- QUANTITY 1 unit.
REASON Blood product, which tested negative for the
antibody to the human immunodeficiency virus
types 1 and 2 (anti-HIV-1/2), but was
collected from a donor who previously tested
repeatedly reactive for anti-HIV-1, was
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-192-6.
CODE Unit #41-17773.
MANUFACTURER Michigan Community Blood Center, Grand Rapids,
Michigan.
RECALLED BY Manufacturer, by letter dated December 2,
1993. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an
extended expiration date, was distributed.
_______________
UPDATE Recall #B-144-6, Red Blood Cells, Unit
56H00385, recalled by American Red Cross Blood
Services, Syracuse, New York, which appeared
in the December 27, 1995, Enforcement Report
as a Class II recall has been reclassified as
a Class III recall.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Orthophos Dental Panoramic Diagnostic X-Ray
Imaging System, Model 3/3C. Recall #Z-240-6.
CODE Serial numbers 1654 and below.
MANUFACTURER Siemens AG, Bensheim, Germany.
RECALLED BY Pelton & Crane Company, Division Siemens
Medical Systems, Charlotte, North Carolina, by
letter on October 5, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 163 units.
REASON If rotating section were to tilt and hit
patient in the head, this could result in
scalp laceration or facial injury.
_______________
PRODUCT Mobile X-Ray Systems: (a) Stenoscop 1 Model
828490/828490G15/828490G015; (b) Stenoscop
D6/D9 Model 828490G015/828490G025.
Recall #Z-364/365-6.
-11- CODE Serial numbers (a) 88/11438/01 through
90/11466/05; (b) Model 828490G015: Serial
numbers 89/11000/01 through 91/10958/10,
Model 828490G025: Serial numbers 91/10959/01
through 93/11029/10.
MANUFACTURER General Electric Medical Systems (GEMS),
Lancin, Belgium.
RECALLED BY General Electric Medical Systems (GEMS),
Waukesha, Wisconsin, by issuing a Field
Modification Instruction (FMI 11663) on April
18, 1995. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,007 units.
REASON The casters upon which the cart is supported
during transport can come off, allowing the
cart to tip over, possibly resulting in cuts,
abrasions, or broken bones.
_______________
PRODUCT Surcell Strep A Test Kit, an enzyme
immunoassay for the visual detection and
confirmation of Group A Streptococcal Antigen
from throat swabs and blood agar plates.
(a) Catalog No. 805-4926, 25 test kits,
(b) Catalog No. 129-2994, 100 test kits.
Recall #Z-372/373-6.
CODE Lot numbers: (a) STC 30954; (b) STH 30896,
STH 30897, STH 30902, STH 30928.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Inc.,
Rochester, New York.
RECALLED BY Manufacturer, by letter dated November 14,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 687 kits were distributed.
REASON The test kit bottle A reagent conjugate was
contaminated with bacteria causing an
unacceptable level of background color in all
three wells, which could cause invalid test
results.
RECALL AND FIELD CORRECTIONS DEVICES -- CLASS III ===========
_______________
PRODUCT Neoprobe 1000, Portable Radioisotope Detector
Probe, used either externally, or intra-
operatively, for the medical procedures where
gamma emitting isotopes are administered.
Recall #Z-330-6.
-12- CODE Serial Numbers: DP90102, DP90115, DP91103,
DP91112, DP91117, DP91119, DP91120, DP91121,
DP91124, DP91128, DP91130, DP91135, DP93090,
DP94003, DP94007, DP94008, DP94017, DP94032,
DP94040, DP94041.
MANUFACTURER Random Corporation, Cincinnati, Ohio.
RECALLED BY Neoprobe Corporation, Dublin, Ohio, by letter
November 8, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 20 probes were distributed.
REASON The detector probe may become damaged after
being subject to repeated complete immersions
in an enzymatic cleaning solution.
_______________
PRODUCT HomeChoice Automated PD Set with Cassette, a
single use disposable peritoneal dialysis set
designed for use with the HomeChoice Automated
Peritoneal Dialysis System (5C4471) only:
(a) Product Code 5C4468; (b) Product Code
5C4469; (c) Product Code T5C4452.
Recall #Z-338/340-6.
CODE All lots that begin with H94, H95A, H95B,
H95C01 through H95C05, and lots H95C06XXX
through H95L12XXX with the 7th and 8th digits
equal to 58, 59 or 60 (product code 5C4468 - 9
lots, product code R5C4478 - 3 lots, product
code 5C4469 - 364 lots, product code R5C4479 -
115 lots, product code T5C4452 - 60 lots).
MANUFACTURER Baxter Healthcare Corporation, Mountain Home,
Arkansas.
RECALLED BY Baxter Healthcare Corporation, McGaw Park,
Illinois, by letter dated December 22, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,215,690 sets were distributed domestically
and 581,156 sets were distributed
internationally; firm estimated that less than
20 percent of product remained on market at
time of recall initiation.
REASON Some sets have the heater line and drainage
line switched.
_______________
PRODUCT Codman ME2 (Micro Endoscopic Electrode),
Catalog #83-1367, Sterile, single use,
indicated for cutting tissue during endoscopic
procedures. Recall #Z-363-6.
-13- CODE Catalog #83-1367, Lot numbers: GM-403,
DM-610, DM-404, DM-413, BM-598, BM-581, AM-
580, AM-510, AM-526, ML-634, LL-498, LL-497,
CL-416, CL-436, CL-403, CL-402, AL-489, MK-
472, MK-471, MK-470, MK-469, MK-468.
MANUFACTURER Medical Disposables International (MDI), West
Conshohocker, Pennsylvania.
RECALLED BY Johnson & Johnson Professional, Inc., Raynham,
Massachusetts, by letter dated November 15,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,255 units.
REASON The unit's metal tip could deliver HF current
to healthy/non-target tissue.
_______________
PRODUCT Sarstedt 0.75 ml Microvette CB1000 1 ml
Lithium Heparin, used for plasma separation.
Recall #Z-366-6.
CODE Part #17.458.100, Lot #52645074.
MANUFACTURER Sarstedt, Numbrecht, Germany.
RECALLED BY Sarstedt, Inc., Newton, North Carolina, by
letter dated October 26, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION California, Connecticut, Indiana,
Massachusetts, Michigan, North Carolina,
Oregon, Tennessee, Wisconsin.
QUANTITY 35,000 pieces were distributed; firm estimated
that 46 percent of product remained on market
at time of recall initiation.
REASON A hairline crack may exist at the opening of
the sample tube, that may result in leakage.
_______________
PRODUCT Surcell Chlamydia Test Kits, for the visual
detection of Chlamydia Antigen as an aid in
the diagnosis of Chlamydia infection, for in-
vitro diagnostic use: (a) Catalog No.
193-7804, 10 test kits; (b) Catalog No.
825-0003, 25 test kits; (c) Catalog No.
196-8056, 100 test kits. Recall #Z-367/369-6.
CODE Lot Numbers: (a) CHT09481 and CHT09555;
(b) CHC09556, CHC09528, CHC09532, CHC09559,
CHC09484, CHC09454, CHC09508; (c) CHH09456,
CHH09477, CHH09482, CHH09509, CHH09549.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Inc.,
Rochester, New York.
RECALLED BY Johnson & Johnson Clinical Diagnostics, Inc.,
Rochester, New York, by memorandum dated
December 29, 1994, and by letters dated
January 5 and 10, 1995. Firm-initiated recall
complete.
-14- DISTRIBUTION Nationwide and international.
QUANTITY 3,722 kits were distributed.
REASON The test kit has poor color development with
low levels of test antigen which could result
in false negative being reported when low
levels of antigen are present in the patient
sample.
-15-
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