FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and
Drug Administration,
U.S. Public Health Service, Department of Health and Human
Services. It contains information
on actions taken in connection with agency regulatory
activities.
February 26, 1997 97-09
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT POWERaDE Lemon-Lime Thirst Quencher, in 20
ounce containers. Recall #F-237-7.
CODE Lot #6346WT.
MANUFACTURER The Minute Maid Company, Waco, Texas.
RECALLED BY Coca Cola Company, Atlanta, Georgia, by fax,
followed by telephone on February 3, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, California, Nevada, Arizona, Hawaii,
Oklahoma, New Mexico, Guam.
QUANTITY 8,411/24 bottles per case were distributed.
REASON The product contains undeclared FD&C Yellow
No. 5. Some bottles containing Lemon-Lime
flavor are labeled as Mountain Blast flavor,
which does not list FD&C Yellow No.5 as an
ingredient.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Welch's White Grape Classics Juices, 3
varieties: (a) White Grape Peach; (b) White
Grape Raspberry; (c) White Grape Cranberry.
Recall #F-238/240-7.
CODE The code, found on the cap is 9 digits. These
codes represent the first 5 digits of the
9-digit code. White Grape Peach: 6N14K,
6N15K, 6N26K, 6N03L, 6N04L, 6N18L, 6N19L,
6N20L, 7N08A, 7N21A, 7N22A, 6N22K, 6N13L,
7N16A; White Grape Raspberry: 6N27K, 6N05L,
6N06L, 7N09A, 7N22A, 7N27A, 6N22K;
White Grape Cranberry: 6N06L, 7N22A, 7N17A.
MANUFACTURER Welch's, North East, Pennsylvania.
RECALLED BY Welch's, Westfield, New York, by telephone and
letter issued 1/30/97. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 150,225 cases were distributed.
REASON Products are contaminated with mold.
_______________
PRODUCT Minute Maid (a) Fruit Punch, in 64 ounce and
128 ounce packages; (b) Grape Punch, in 64
ounce packages. Recall #F-241/242-7.
CODE (a) JAN13 PWA xxxx CT349
JAN13 PWB xxxx CT349 (64 ounce)
2645 xxxx JAN13 T35598A
Fruit Punch (64 ounce shipping case;
BEST BEFORE JAN 13
PWE xxxx CT349 (128 ounce package);
xx:xx PWE JAN 13 T35598A (128 ounce
shipping case)
(b) JAN13 PWC xxxx CT349 (64 ounce package)
2635 xx:xx JAN 13 T35594A
Fruit Punch (64 ounce shipping case).
MANUFACTURER The Minute Maid Company, Paw Paw, Michigan.
RECALLED BY The Minute Maid Company, Houston, Texas, by
public affairs statement on December 11, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Midwest.
QUANTITY (a) 3,141 cases (64 ounce) 4,766 cases (128
ounce); (b) 1,512 cases were distributed.
REASON Products are contaminated with a small amount
of acid sanitizer.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT Target brand Creamy Baby Oil, in 16 fluid
ounce bottles. Recall #F-236-7.
CODE Lot #609301.
MANUFACTURER Benjamin Ansehl Corporation, St. Louis,
Missouri.
RECALLED BY Manufacturer, by letter dated November 25,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Arkansas, Georgia, Minnesota, Wisconsin,
Colorado, Oregon, California, Indiana.
-2-QUANTITY 223 cases (12 bottles per case) (2,676 units)
were distributed.
REASON Product is contaminated with Burkholderia
cepacia, a pathogen.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Doxycycline Hyclate, 100 mg Capsules, USP, in
bottles of 50 and 500, Rx, a broad spectrum
antibiotic. Recall #D-118-7.
CODE Various labels and lot numbers as follows:
(a) Aligen Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules
distributed by Aligen Independent
Laboratories, Inc., Jackson Hole, Wyoming
Lots: 55301M3 EXP 10/98 and 55310M3 EXP
10/98
(b) Aligen Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules
distributed by Aligen Independent
Laboratories, Inc., Jackson Hole, Wyoming
Lots: 55304H3 EXP 08/98 and 55303M3 EXP 10/98
(c) Doxychel Doxycycline Hyclate 100 mg
Capsules in bottles of 50 capsules, Rachelle
Laboratories, Inc., Culver, Indiana, Lot:
55303R3 EXP 11/98
(d) Doxychel Doxycycline Hyclate 100 mg
Capsules in bottles of 500 capsules, Rachelle
Laboratories, Inc., Culver, Indiana,
Lots: 55302M3 EXP 10/98, 55305M3 EXP 10/98,
55306M3 EXP 10/98, 55308M3 EXP 10/98, 55309M3
EXP 10/98, and 55308R3 EXP 11/98
(e) Geneva Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules
distributed by Geneva Pharmaceuticals, Inc.,
Broomfield, Colorado, Lots: 55310M3 EXP 10/98
and 55306R3 EXP 11/98
(f) Geneva Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules
distributed by Geneva Pharmaceuticals, Inc.,
Broomfield, Colorado, Lots: 55307H3 EXP 08/98
and 55303R3 EXP 11/98
(g) Halsey Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules,
Halsey Drug Co., Inc., Brooklyn, New York
Lots: 55306H3 EXP 08/98, 55310M3 EXP 10/98,
55303R3 EXP 11/98, and 55306R3 EXP 11/98
(h) Halsey Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules,
Halsey Drug Co., Inc., Brooklyn, New York
-3- Lots: 55306H3 EXP 08/98, 55304H3 EXP 08/98,
55307H3 EXP 08/98, 55308H3 EXP 08/98, 55301K3
EXP 09/98 and 55307A4 EXP 11/98
(i) Major Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules, Major
Pharmaceutical Corp., Chicago, Illinois, and
labeled "Manufactured by Halsey Drug Co.,
Inc., Brooklyn, N.Y." Lots: 55306H3 EXP
08/98, 55309H3 EXP 08/98, 55310M3 EXP
10/98 and 55306R3 EXP 11/98
(j) Major Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
Major Pharmaceutical Corp., Chicago, Illinois
and labeled "Manufactured by Halsey Drug Co.,
Inc., Brooklyn, N.Y." Lots: 55307H3 EXP
08/98, 55308H3 EXP 08/98, 55302M3 EXP 10/98
and 55306R3 EXP 11/98
(k) Mason Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
Mason Distributors, Inc., Hialean, Florida,
and labeled "Mfd. by Halsey Drug Co., Inc.,
Brooklyn, N.Y." Lots: 55303M3 EXP 10/98 and
55301R3 EXP 11/98
(l) Moore Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules distributed by
h.l. Moore Drug Exchange, New Britain,
Connecticut, and labeled "Mfg. by Halsey Drug
Co., Inc., Brooklyn, N.Y." Lots: 55306H3 EXP
08/98, 55309H3 EXP 08/98, 55310M3 EXP 10/98
and 55306R3 EXP 11/98
(m) Moore Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules distributed by
h.l. Moore Drug Exchange, New Britain,
Connecticut, and labeled "Mfg. by Halsey Drug
Co., Inc., Brooklyn, N.Y." Lots: 55304H3 EXP
08/98, 55308H3 EXP 08/98, 55301K3 EXP 09/98,
55302M3 EXP 10/98
(n) Parmed Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules
distributed by Parmed Pharmaceuticals, Inc.,
Niagara Falls, New York, and labeled "Mfg. by:
Halsey Drug Co., Inc., Brooklyn, N.Y."
Lot: 55310M3 EXP 10/98
(o) Parmed Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules
distributed by Parmed Pharmaceuticals, Inc.,
Niagara Falls, New York, and labeled "Mfg. by:
Halsey Drug Co., Inc., Brooklyn, N.Y."
Lot: 55302M3 EXP 10/98
(p) Qualitest Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules and
labeled "Mfg. for: Qualitest Products, Inc.,
-4- Huntsville, Alabama. Mfg. by: Halsey Drug
Co, Inc., Brooklyn, N.Y." Lots: 55309H3 EXP
08/98, 55310M3 EXP 10/98 and 55306R3 EXP 11/98
(q) Qualitest Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules and
labeled "Mfg. for: Qualitest Products, Inc.,
Huntsville, Alabama. Mfg. by: Halsey Drug Co.,
Inc., Brooklyn, N.Y." Lots: 55306H3 EXP
08-98, 55303M3 EXP 10/98, 55301R3 EXP 11/98,
55303R3 EXP 11/98 and 55306R3 EXP 11/98
(r) URL Doxycycline Hyclate 100 mg capsules,
USP in bottles of 50 capsules and labeled
"Manufactured for United Research
Laboratories, Inc., Bensalem, Pennsylvania
Mfd. By Halsey Drug Co., Inc., Brooklyn, N.Y."
Lots: 55306H3 EXP 08/98 and 55309H3 EXP 08/98
(s) URL Doxycycline Hyclate 100 mg capsules,
USP in bottles of 500 capsules and labeled
"Manufactured for United Research
Laboratories, Inc., Bensalem, Pennsylvania
Mfd. By Halsey Drug Co., Inc., Brooklyn, N.Y."
Lots: 55308H3 EXP 08/98 and 55301K3 EXP 09/98
(t) Warner Chilcott Doxycycline Hyclate 100 mg
capsules, USP in bottles of 50 capsules and
labeled "Manufactured for: Warner Chilcott
Labs, Div of Warner-Lambert Co., Morris
Plains, New Jersey By: Halsey Drug Co., Inc.,
Brooklyn, NY" Lots: 94953W EXP 08/98 and
55301M3 EXP 10/98
(U) Warner Chilcott Doxycycline Hyclate 100 mg
capsules, USP in bottles of 500 capsules and
labeled "Manufactured for: Warner Chilcott
Labs, Div of Warner-Lambert Co., Morris
Plains, New Jersey By: Halsey Drug Co., Inc.,
Brooklyn, NY" Lots: 92183W EXP 08/98, 55304M3
EXP 10/98 and 55311R3 EXP 11/98.
MANUFACTURER Houba, Inc., a subsidiary of Halsey Drug
Company, Inc., Culver, Indiana.
RECALLED BY Manufacturer, by letter dated January 3,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12 million capsules were distributed.
REASON Stability is not assured through expiration
date (capsules may be excessively brittle).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Nitrostat Sublingual Tablets, 0.4 mg
(Nitroglycerin Tablets USP), in bottles of 25,
Rx indicated for the acute relief of an attack
or prophylaxis of angina pectoris due to
coronary artery disease. Recall #D-119-7.
-5-CODE Lot #01385F EXP 7/97.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert
Company, Morris Plains, New Jersey, by letter
on January 28, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 23,750 bottles were distributed.
REASON Product lacks stability (failed content assay
at the 15-month stability timepoint -- 86.6%;
SPEC is 90-110%).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma. Recall
#B-392/395-7.
CODE Unit numbers: (a) 40GT45582, 40FE28598;
(b) 40FE28598; (c) 40GT45582; (d) 40FE28598.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on July 23, 1996,
followed by letter dated July 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois and Iowa.
QUANTITY (a) 2 Units; (b) 1 unit; (c) 1 unit; (d) 1
unit was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), but were subjected
to additional retesting.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall B-396/397-7.
CODE Unit numbers: 40GT45738 and 40FF10967.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on July 23, 1996,
followed by letter dated July 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION New York, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), but were subjected
to additional retesting.
_______________
PRODUCT Platelets, Pheresis. Recall #B-400-7.
CODE Unit #40Z02306.
-6-MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on August 17, 1996,
followed by letter dated August 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1).
_______________
PRODUCT Platelets, Pheresis. Recall #B-401-7.
CODE Unit #47P13992.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on August 28, 1996,
followed by letter. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), and was not
retested in duplicate.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-402/403-7.
CODE Unit #40GT45540.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on July 23, 1996,
followed by letter dated July 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), but were subjected
to additional retesting.
_______________
PRODUCT Red Blood Cells. Recall #B-410-7.
CODE Unit numbers: 49J64513, 49J66367, 49Q39644,
49Q46019.
MANUFACTURER American National Red Cross, Norman, Oklahoma.
RECALLED BY Manufacturer, by letter dated October 22,
1996. Firm-initiated recall complete.
DISTRIBUTION Texas and Oklahoma.
QUANTITY 4 units were distributed.
-7-REASON Blood products were collected from a donor who
lived in an area designated as endemic for
malaria.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====
_______________
PRODUCT Platelets. Recall #B-381-7.
CODE Unit #98077.
MANUFACTURER United Community Blood Center, Middleburg
Heights, Ohio.
RECALLED BY Manufacturer, by telephone on June 2, 1994.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for antibodies
screen and was labeled as negative for
unexpected antibodies.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-398/399-7.
CODE Unit #40GR49468.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on August 17, 1996,
followed by letter dated August 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested repeatedly reactive for
the hepatitis B surface antigen (HBsAg), but
were subjected to additional retesting. The
donor has since met reentry.
_______________
PRODUCT Platelets, Pheresis. Recall #B-404-7.
CODE Unit #29FP31448.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by letter dated January 31,
1996. Firm-initiated recall complete.
DISTRIBUTION West Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had been immunized with Measles, Mumps, and
Rubella (MMR) vaccine.
_______________
PRODUCT Red Blood Cells. Recall #B-405-7.
CODE Unit #21GH57280.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
-8-RECALLED BY Manufacturer, by letter dated June 21, 1996.
Firm-initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was shipped
interstate.
_______________
PRODUCT Red Blood Cells. Recall #B-406-7.
CODE Unit numbers: 21R37286 and 21R37289.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated July 9, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 2 units were distributed.
REASON Blood products remained at room temperature
for an unacceptable length of time.
_______________
PRODUCT Red Blood Cells. Recall #B-408-7.
CODE Unit numbers: 20264-4471, 20264-4478, 20264-
7103, 20264-7213, 20264-7216, 20263-7037,
20264-7359, 20265-0169.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Lafayette, Louisiana.
RECALLED BY Manufacturer, by letter dated October 30,
1996. Firm-initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY 8 units were distributed.
REASON Blood products remained at room temperature
for an unacceptable length of time.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT Leep Foot Pedal Accessory, Part Number 6032,
used with the Leep System 1000 Generator. The
Leep procedure is indicated in the diagnosis
and treatment of some Cervical Intraepithelial
Neoplasia (CIN) in patients. Recall #Z-253-7.
CODE Serial Numbers of Generator Units:
9512F300 - 9512F324, 9601F325 - 9601F374,
9605F375 - 9005F449.
MANUFACTURER Alsa Apparecchi, Bologna, Italy (foot pedal).
RECALLED BY Cooper Surgical, Shelton, Connecticut, by
letter on November 11, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 132 units were distributed.
REASON The foot pedal air bladder may crack and
prevent activation of the Leep device.
-9-_______________
PRODUCT Diagnostic X-Ray System - SuperStand, general
purpose radiography:
(a) Model No. WWS0004 SuperStand;
(b) Model No. WWS0005 SuperStand;
(c) Model No. WWS0007 SuperStand;
(d) Model No. WWS0008 SuperStand.
Recall #Z-270/273-7.
CODE All units.
MANUFACTURER Wuestec Medical, Inc., Mobile, Alabama.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on February 18, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY All units produced.
REASON The diagnostic x-ray devices were found
noncompliant with 21 CFR 1010.2 and 1010.3 of
the Federal Performance Standard for
Diagnostic X-Ray System and Their Major
Components. Some of the devices were
improperly identified and certified to the
diagnostic x-ray standard.
_______________
PRODUCT Royal Flush Plug Angiographic Catheters with
Beacon Enhanced Radiopaque Tips, sold as part
of the following sets:
(a) Cook Brand Digital Subtraction Angiography
Set 4.0 French, 80cm Catheter, Reorder No.
DSA-400HL-Hirata-071196;
(b) Cook Brand Royal Flush Plus Angiographic
Set 4f, 90cm, CFP, Reorder No.
HNS-404-90-CFP-MSMH-100893;
(c) Cook Brand Royal Flush Plus Angiographic
Set with Beacon Tip 4FR Pigtail, Reorder No.
HNRS-403-50-CFP-ST-PAUL-110790;
(d) Cook Brand Royal Flush Plus Angiographic
Set with Beacon Tip 4 FR Pigtail, Reorder No.
HNRS-403-60-CFP-ST-PAUL-110790;
(e) Cook Brand Flush Plus Angoiographic Set
with Beacon Tip 4 FR Pigtail, Reorder No.
HNRS-403-75-CFP-ST-PAUL-110790;
(f) Cook Brand Royal Flush Plus Angiographic
Set with Beacon Tip 4FR Pigtail, Reorder No.
HNRS-403-70-PIG-SPH-012795;
(g) Cook Brand Royal Flush Plus Angiographic
Set with Beacon Tip 5 FR Pigtail, Reorder No.
HNRS-503-70-PIG-MFH-111296;
(h) Cook Brand Judkins Coronary Catheter Set
with Micropuncture Check-Flo Performer
Introducer Set, Reorder No. JCS-600-SA-090695.
Recall #Z-274/281-7.
-10-CODE All product manufactured since November 16,
1995.
MANUFACTURER Sabin Corporation, Bloomington, Indiana.
RECALLED BY Cook, Inc., Bloomington, Indiana, by letter
dated January 16, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 68,345 sets were distributed.
REASON There has been an increase frequency of
catheter tip separation.
_______________
PRODUCT All promotional material for ElectroMedia Air
Cleaners, Model numbers 50C, 100C, and 35F, a
medical recirculating air cleaner which can be
used in industrial settings, but is also used
by medical facilities. Recall #Z-282-7.
CODE Promotional material is for all codes for
model numbers 35F, 50C, and 100C.
MANUFACTURER It's All About Clean Air, Inc., Glasgow,
Kentucky.
RECALLED BY Manufacturer, by letter on January 27, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,500 to 2,000 pieces of
literature and/or brochures were distributed.
REASON The firm's advertisements/promotional material
contain medical claims for which the firm does
not have an approved 510(k).
_______________
PRODUCT 72" Adult Heated Wire Breathing Circuits, used
to provide heat to the humidified air passing
to the patient's trachea through a breathing
tube attached to a ventilator.
Recall #Z-285-7.
CODE Product Code Lot Number
1570240 97544
1572347 97241
97508
157606 97144
97552
97980
1576073 97178
97723
157610 96749
97177
97707
1576139 97398
157615 96892
97855
-11- 1576162 96750
97145
97249
157617 97724
97982
157620 96940
97553
1576214 96941
97250
97399
97726
1576380 97245
157657 97121
1576689 96935
97720
97977
1576712 96576
542031 96741
97246
97550
97848.
MANUFACTURER Marquest Medical Products, Inc., Englewood,
Colorado
RECALLED BY Manufacturer, by letter on November 1, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,001 units were distributed.
REASON A manufacturing process error in which the
electrical insulation of the wire was scored
during assembly, exposing the metallic
conductor to the environment within the
breathing circuit.
_______________
PRODUCT Model I/O 104 rev A laser Ablation System,
used for ablation of material from a surface
laving a graphic image or letters on that
surface. Recall #Z-286-7.
CODE Model I/O rev A laser Ablation System
"Micropoint Ablation Laser".
MANUFACTURER Imaginative Optics, Beverly, Massachusetts.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on February 19, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 35 units were distributed.
REASON The laser product failed to comply with the
following provisions of the Federal laser
product performance standard for: labeling
requirements -- product failed to have the
correct warning logotype affixed to it;
-12- information requirements -- product user
manual failed to include a reproduction of the
required warning logotype and the statement
"Cautions - Use of controls ..."; and
Identification -- products failed to have
affixed to it an identification label
containing the date of manufacture stated in
the proper form.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Branemark System Sterile Mk II 5 x 13 mm wide
Platform Fixture, Catalog #SDCA 668, a self-
tapping endosseous implant fixture.
Recall #Z-250-7.
CODE Lot #530423.
MANUFACTURER Nobel Biocare AB, Gothenburg, Sweden.
RECALLED BY Nobel Biocare USA, Inc., Westmont, Illinois,
by telephone on December 20, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION California, New York, Florida, Pennsylvania,
Texas, New Mexico, Illinois.
QUANTITY 22 fixtures were distributed.
REASON The vials labeled as containing a 5 x 13 mm
wide platform fixture actually contain a 3.3 x
15 mm narrow platform fixture.
_______________
PRODUCT Branemark System Sterile carbon steel drills,
single use drills, countersinks and pilot
drills used to prepare the bone for endosseous
implant fixtures:
(a) Catalog #SDIB 001 - Drill Kit, 7-10 mm
(b) Catalog #SDIB 004 - Drill Kit, 7-15 mm
(c) Catalog #SDIB 133 - Drill Kit, Long Shaft,
L 7-15 mm
(d) Catalog #SDIB 091 - Twist Drill, d 2.0 mm,
L 7-15 mm
(e) Catalog #SDIB 092 - Twist Drill, d 2.0 mm,
L 13-20 mm
(f) Catalog #SDIB 003 - Twist Drill, d 3.0 mm,
L 7-10 mm
(g) Catalog #SDIB 081 - Twist Drill, d 3.0 mm,
L 7-15 mm
(h) Catalog #SDIB 086 - Twist Drill, d 3.0 mm,
L 13-20 mm
(i) Catalog #SDIB 135 - Twist Drill, d 3.0 mm,
L 7-15 mm Long Shaft
(j) Catalog #SDIB 268 - Twist Drill, d 3.15
mm, L 7-15 mm
-13- (k) Catalog #SDIB 269 - Twist Drill, d 3.15
mm, L 13-20 mm
(l) Catalog #SDIB 274 - Twist Drill, d 4.3 mm,
L 6-12 mm
(m) Catalog #SDIB 021 - Countersink, Short
(n) Catalog #SDIB 005 - Countersink, Long
(o) Catalog #SDIB 136 - Countersink, Long
Shaft
(p) Catalog #SDIB 291 - Pilot Drill, d 4.3/3
mm. Recall #Z-254/269-7.
CODE All carbon-steel drills, lots 522558 through
524432.
MANUFACTURER Nobel Biocare AB, fka Nobelpharma AB,
Gothenburg, Sweden.
RECALLED BY Nobel Biocare USA, Inc., fka Nobelpharma USA,
Westmont, Illinois, by letter dated May 17,
1996. Firm-initiated recall compete.
DISTRIBUTION Nationwide.
QUANTITY 9,689 units were distributed.
REASON The carbon steel surface of the devices may
have oxidized.
_______________
PRODUCT Autoclavable Retractor Systems, non-sterile:
(a) Model 3404; (b) Model 3407.
Recall #Z-283/284-7.
CODE Lot numbers: (a) 2089; (b) 2074.
MANUFACTURER Lone Star Medical Products, Inc., Houston,
Texas.
RECALLED BY Manufacturer, by letter mailed on or about
August 23, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Maine, New York, Michigan, Connecticut.
QUANTITY (a) 3 units; (b) 7 units were distributed.
REASON The inner insert label was labeled as
"sterile", while the outer label was correctly
labeled as "Non-sterile".
-14-
END OF ENFORCEMENT REPORT FOR FEBRUARY 26, 1997. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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