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
06/15/1994
Recalls and Field Corrections: Foods -- Class II -- 06/15/1994
June 15, 1994 94-24
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Strawberry Toppings under the following labels and package
sizes: (a) Hardee's Strawberry Topping, in 26.5 fluid ounce
pouches; (b) Strawberry Sundae Topping, under the Quaker
Oats Company label for exclusive use by McDonald's
Restaurants, in 32 fluid ounce pouches; (c) Sysco Classic
Strawberry Topping, in 46 fluid ounce cans. These are food
service items, not for retail sale. Recall #F-415-4.
CODE (a) Use thru Dec 31 94; (b) Use thru Dec 31 94, lot #9412;
and Use thru Jan 08 95, lot #9431; (c) 4Q15D.
MANUFACTURER The Quaker Oats Company, doing business as Richardson Foods
Corporation, Macedon, New York.
RECALLED BY Manufacturer, by telephone May 3, 1994, followed by letter
May 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 724 cases (6 pouches per case); (b) 2,147 cases (12
pouches per case); (c) 628 cases (6 cans per case).
REASON Product contains pieces of plastic.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Gatorade, in 32 fluid ounce plastic bottles. Flavors are:
(a) Orange; (b) Iced Tea Cooler (lemon and tea);
(c) Grape; (d) Lemon-Lime; (e) Fruit Punch.
Recall #F-416/420-4. CODE Flavor Case Code Bottle Code
Orange 03-24-94 024C4* (see note)
Lemon-Lime 03-24-94 024C4*
Grape 03-25-94 025C4*
Fruit Punch 03-25-94 025C4*
Iced Tea 03-26-94 026C4*
(Note: Bottle code could end in A,B,C,D,E, or H)
Warehouse Club Shipments:
Flavor Pallet Code
Lemon-Lime 04-06-94
Orange 040894
MANUFACTURER Quaker Oats Company, Oakland, California.
RECALLED BY Manufacturer, by letter April 21, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona, California, Hawaii, Idaho, Montana, Nevada, Oregon,
Utah, Washington state.
QUANTITY 33,217 cases (24 bottles per case) were distributed.
REASON Product is contaminated with mold.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Amoxicillin Oral Suspension, in 100 ml bottles, Rx oral
antibiotic: (a) 125 mg/5 ml; (b) 250 mg/5 ml.
Recall #D-295/296-4.
CODE Lot numbers: (a) 3270075, 3279117; (b) 3134029, 3298063,
3099022.
MANUFACTURER Biocraft Laboratories, Elmwood Park, New Jersey (responsible
firm).
RECALLED BY Allscrips Pharmaceuticals, Inc., Vernon Hills, Illinois
(relabeler), by letter May 18, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 723 bottles; (b) 2,020 bottles were distributed.
REASON Product does not meet stability specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Xenon Xe 133 Gas - radioactive diagnostic for inhalation
administration: (a) 10 millicuries (mCi), Catalog #N097;
(b) 20 millicuries (mCi), Catalog #N098.
Recall #D-297/298-4.
CODE Lot numbers: (a) 0974016; (b) 0984016.
MANUFACTURER Mallinckrodt Medical, Inc., Maryland Heights, Missouri.
RECALLED BY Manufacturer, by telephone May 5, 1994, followed by letter
May 9, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Buenos Aires, Canada, Mexico.
QUANTITY Approximately (a) 1,270 vials; (b) 1,195 vials were
distributed.
REASON Low assay of radioactive component.
-2- _______________
PRODUCT Calplus brand of Calcium Chloride Dihyrate, USP, in 110
pound drums, a bulk tested additive chemical for
manufacturing, processing, or repacking food or drug
products. Recall #D-299-4.
CODE Lot #SLM018.
MANUFACTURER Nichea, Tokyo, Japan.
REPACKER Clinton Universal Warehouse, Newark, New Jersey.
RECALLED BY Mallinckrodt Chemical, Inc., St. Louis, Missouri, by
telephone April 29, 1994, followed by letter May 9, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, California.
QUANTITY 97 drums were distributed.
REASON Current good manufacturing practice deficiency by recalling
firm.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-317-4.
CODE Unit #03T97357.
MANUFACTURER The American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone August 17, 1993, followed by
letter August 23, 1993. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit.
REASON Blood product collected from a donor with a history of
cancer was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
UPDATE Recall #B-275/281-4, manufactured by American Red Cross
Blood Services, Dedham, Massachusetts, which appeared in the
June 8, 1994 should read:
PRODUCT: (a) Red Blood Cells; (b) Platelets; (c) Platelets,
Expired; (d) Red Blood Cells, For Further Manufacture; (e)
Cryoprecipitated AHF; (f) Fresh Frozen Plasma; (g) Recovered
Plasma. Recall #B-275/281-4.
CODE Unit numbers: (a) 04C17643, 04F06443, 04FC51677,
04GF56801, 04GF58444, 04GF60232, 04GF64890, 04KK87617,
04KK90263; (b) 04F06443, 04GF58444, 04GF60232, 04KK90263;
(c) 04C17643, 04GF63060; (d) 04GF3060; (e) 04KK87617,
04KK90263; (f) 04F06443, 04C17643; (g) 04FC51677, 04GF56801,
04GF58444, 04GF60232, 04GF63060, 04KK87617, 04KK90263.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT FT-Ramean Accessory, used to perform laser-excited Ramean
spectroscopy on chemical samples. Recall #Z-593-4.
CODE None.
-3- MANUFACTURER Digilab Division, Bio-Rad, Cambridge, Massachusetts.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan March 25, 1994. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 10 units.
REASON The laser product failed to provide either multiple
interlocks or a fail-safe design for the required safety
interlocks.
_______________
PRODUCT Hycor Coated Tube RIA, HS-TSH Immunoradiometric Assay,
Thyroid Stimulating Hormone (TSH), intended for use in
immunoradiometric assay (IRMA) for the quantitative
determination of TSH. Recall #Z-719-4.
CODE Lot #24857 EXP 9/14/94.
MANUFACTURER Hycor Biomedical, Inc., Garden Grove, California.
RECALLED BY Manufacturer, March 8, 1994. Firm-initiated recall
complete.
DISTRIBUTION United Kingdom.
QUANTITY 90,575 tubes were distributed; FDA estimates that little if
any product remains on the market.
REASON Not all tubes contain the antibody coating that is indicated
on the label which may result in neonates with
hypothyroidism (cretinism) being misdiagnosed as normal.
_______________
PRODUCT Ferno Washington Ambulance Transportation Cots:
(a) Model 35-A; (b) Model 35-NM; (c) 35-IT.
Recall #Z-742/744-4.
CODE All lots.
MANUFACTURER Ferno Washington, Inc., Wilmington, Ohio.
RECALLED BY Manufacturer, by letter January 10, 1994. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 13,000 units were distributed.
REASON Products have an unsafe sliding area in which an attendant
(bystander), while assisting in loading the units can
position the hands near the X-frame slides in such a way as
to cause serious finger injuries.
_______________
PRODUCT Conseal brand Colostomy Continence Systems:
(a) Part No. 1235; (b) Part No. 1245; (c) Part No. 1285;
(d) Part No. 1295; (e) Part No. 1435; (f) Part No. 1445;
(g) Part No. 1485; (h) Part No. 1495. Recall #Z-833/840-4.
CODE All codes starting with 37788 through 84255.
MANUFACTURER Coloplast A/S, Espergaerde, Denmark.
RECALLED BY Coloplast, Inc., Tampa, Florida, by letter December 3, 1993.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 500 to 600 boxes of 10 units each.
-4- REASON The foam liner may separate from the plug and remain behind
in the stoma when the plug is removed.
_______________
PRODUCT Intraocular Lens, Model 815A, 11.50 and 21.50 diopters, used
to replace the natural lens in the visual correction of
aphakia in patients 60 years of age or older.
Recall #Z-854-4.
CODE Lenses sterility lot #031293A.
MANUFACTURER Pharmacia Ophthalmics, Inc., Monrovia, California.
RECALLED BY Manufacturer, by letters of December 10, 1993, and February
16, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Colorado, Florida, Iowa, Illinois,
Louisiana, Maryland, Minnesota, New York, Ohio,
Pennsylvania, South Dakota, Texas, Utah, Vermont, Australia.
QUANTITY Firm estimates no unimplanted lenses remain on the market.
REASON Devices may be labeled with the incorrect dioptric power,
which would result in a refractive error if implanted.
_______________
PRODUCT Disposable Laryngoscope Blades, used with the Laryngoscope
for the ocular examination of the larynx of adults and
pediatrics: (a) Macintosh size 2 blades, Product Nos.
9942-00 & 9982-00;
(b) Macintosh size 3 blades, Product Nos. 9943-00 & 9983-00;
(c) Macintosh size 4 blades, Product Nos. 9944-00 & 9984-00;
(d) Miller size 0 blades, Product Nos. 9960-00 & 9967-00;
(e) Miller size 1 blades, Product Nos. 9961-00 & 9968-00;
(f) Miller size 2 blades, Product Nos. 9962-00 & 9969-00;
(g) Miller size 3 blades, Product Nos. 9963-00 & 9971-00;
(h) Cabinet, with Macintosh blades, Product No. 9945-00;
(i) Cabinet, with Miller blades, Product #9946-00;
(j) Laryngoscope set with plastic handle, Product #9939-00;
(k) Laryngoscope set with metal handle, Product #9941-00.
Recall #Z-861/871-4.
CODE Lot Nos. 120293 through 030494.
MANUFACTURER Anesthesia Medical Specialties, Santa Fe Springs,
California.
RECALLED BY Manufacturer, by letter March 11, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Germany.
QUANTITY 57,526 blades were distributed.
REASON The blades in some cases have demonstrated a propensity for
breakage during clinical usage.
_______________
PRODUCT Disposable Laryngoscope Blades, used with the Laryngoscope
for the visual examination of the laryngeal orifice of
adults and pediatrics: (a) Macintosh size 3; (b) Miller
Size 1; (c) Miller Size 3; (d) Variety Pack; (e)
Laryngoscope Set. Recall #Z-872/876-4.
-5- CODE Catalog No. Batch No.
(a) 17643 036 through 045
(b) 17661 027
(c) 17663 026
(d) 176-VAR 002, 003, 004
(e) 17686 018 through 021.
MANUFACTURER Anesthesia Medical Specialties, Santa Fe Springs,
California.
RECALLED BY Respiratory Support Products, Irvine, California, by letter
March 14, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, England, France, Netherlands, Taiwan.
QUANTITY 16.785 blades and 335 sets were distributed.
REASON Blades in some cases have demonstrated a propensity for
breakage during clinical usage.
_______________
PRODUCT Grice Abdominal Lift Reddick-Saye Screw Modification,
designed for lifting the abdomen for laparoscopic surgery
under the navel. Recall #Z-897-4.
CODE All lots distributed between 10/13/92 and 6/21/93.
MANUFACTURER Ideas for Medicine, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by verbal notification June 22, 1993. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,077 devices were distributed.
REASON The device fails to function as intended due to lack of
adequate design and quality controls.
_______________
PRODUCT Twenty-one In Vitro Diagnostic products as listed below;
(a) Lyme Disease, Catalog Nos. 283-390, 783-390;
(b) Toxo. IgG, Catalog Nos. 283-300, 783-300;
(c) Rubella IgG, Catalog Nos. 283-300, 783-300;
(d) HSV 1, Catalog Nos. 283-340, 783-340;
(e) VZV, Catalog Nos. 283-380, 783-380;
(f) CMV IgG, Catalog Nos. 283-320, 783-320;
(g) HSV 2, Catalog Nos. 283-350, 783-350;
(h) Rubella IgM, Catalog Nos. 283-370, 783-370;
(i) CMV IgM, Catalog Nos. 283-330, 783-330;
(j) Scl-70, Catalog No. 283-280;
(k) RNP, Catalog Nos. 283-270, 783-270;
(l) SSA, Catalog Nos. 283-250, 783-250;
(m) Sm, Catalog Nos. 283-240, 783-240;
(n) Toxo. IgM, Catalog Nos. 283-310, 783-310;
(o) Measles, Catalog No. 283-520;
(p) DNP, Catalog Nos. 283-230, 783-230;
(q) IC, Catalog No. 783-210;
(r) SSB, Catalog No. 283-260;
(s) DNA, Catalog Nos. 283-200, 783-200;
(t) RF, Catalog Nos. 283-220, 783-220;
(u) Amebiasis, Catalog No. 783-120. Recall #Z-902/922-4.
-6- CODE (a) 40903F EXP 4/94, 40903FA EXP 4/94, 60603F EXP 6/96,
60603FA EXP 6/94, 40903 EXP 4/94, 42703 EXP 4/94, 50703 EXP
5/94, 60603 EXP 6/94, 70303 7/94, 70303F 7/94, 42703F 4/94,
40903A 4/94; (b) 41703F EXP 4/94, 43803 EXP 4/94, 60703F EXP
6/94, 43803 EXP 4/94, 41703 EXP 4/94, 60703 EXP 6/94; (c)
40603F EXP 4/94, 43003F EXP 4/94, 41603 EXP 4/94, 41203 EXP
4/94, 43003 EXP 4/94, 52203 EXP 5/94, 52203F EXP 5/94; (d)
41103F EXP 4/94, 43503F EXP 4/94, 62703F EXP 6/94, 41103 EXP
4/94, 43503 EXP 4/94, 62703 EXP 6/94; (e) 40803F EXP 4/94,
43603F EXP 4/94, 61403F EXP 6/94, 40803 EXP 4/94, 43603 EXP
4/94, 61403 EXP 6/94; (f) 41403F EXP 4/94, 43703F EXP 4/94,
61003F EXP 6/94, 70703F EXP 7/94, 41403 EXP 4/94, 43703 EXP
4/94, 61003 EXP 6/94; (g) 41903F EXP 4/94, 51403F EXP 5/94,
41903 EXP 4/94, 51403 EXP 5/94, 42803 EXP 4/94; (h) 40403F
EXP 4/94, 40303 EXP 4/94, 60903 EXP 6/94; (i) 41803F EXP
4/94, 61903F EXP 6/94, 41803 EXP 4/94, 43303 EXP 4/94, 61903
EXP 6/94; (j) 22603F EXP 2/94; (k) 21203F EXP 2/94, 42203F
EXP 4/94, 62303 EXP 6/94, 21203 EXP 2/94, 62303 EXP 6/94;
(l) 31503F EXP 3/94, 20703 EXP 2/94, 21603F EXP 2/94, 51303F
EXP 5/94, 51303 EXP 5/94, 31403 EXP 3/94; (m) 21503F EXP
2/94, 42103F EXP 4/94, 62903 EXP 6/94; (n) 43203F EXP 4/94,
62503F EXP 6/94, 40703F EXP 4/94, 41303 EXP 4/94, 43203 EXP
4/94, 60503 EXP 6/94, 70403 EXP 6/94; (o) 31103F EXP 3/94;
(p) 30503F EXP 3/94, 30503 EXP 3/94; (q) 31003 EXP 3/94; (r)
51203F EXP 5/94; (s) 20503 EXP 2/94, 20503F EXP 2/94, 42003
EXP 4/94; (t) 70503 EXP 7/94, 20803F EXP 2/94; (u) 21703 EXP
2/94.
MANUFACTURER Diamedix Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter February 2, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 8,833 kits were distributed.
REASON The Cal-Verifier that is shipped with the device kits lacks
a 510(k) approval.
_______________
PRODUCT Bard 9.5 Fr 40cc Double Lumen Intra-Aortic Balloon Catheter,
single use device intended for temporary cardiac assistance
employing the principle of counterpulsation.
Recall #Z-923-4.
CODE Catalog #H-8240, lot numbers: 28LDQ033, 28LDQ035, 28AEQ019,
28AEQ030, 28BEQ019, 28BEQ020, 28IDQ501, 28IDQ502, 28HDQ501.
MANUFACTURER Bard Cardiopulomary Division, C.R. Bard, Inc., Tweksbury,
Massachusetts.
RECALLED BY Bard Cardiopulmonary, Haverhill, Massachusetts, by letter
March 23, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 488 units.
REASON An unknown number of brittle (defective) "Y" bifurcates
could leak, resulting in a loss of helium and the inability
to achieve vacuum configuration.
-7- _______________
PRODUCT Oral Endotracheal Tube Holders, used to anchor and stabilize
the tube, inhibiting extubation and eliminating taping
procedures:
(a) Secure Easy Endotracheal Tube Holder (padded faceplate
with bite block, headgear and neckstrap), Catalog numbers
242003, 242006;
(b) Quickstrap Endotracheal Tube Holder (padded faceplate
with bite block and non-elastic neckstrap), Catalog number
242007. Recall #Z-925/926-4.
CODE Lot numbers: (a) C093, C095; (b) C075, C088, C095.
MANUFACTURER IPI Medical Products, Chicago, Illinois.
RECALLED BY Manufacturer, by letter April 23, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, France.
QUANTITY 5,430 units; firm estimates none remains on the market.
REASON The tube retainer strap may crack when excessive force is
applied.
_______________
PRODUCT Night Vision Image Intensifiers, Models T3C-2 and T3C-3,
used in viewing objects and persons in subdued lighting.
Recall #Z-927/928-4.
CODE None.
MANUFACTURER Novosibirsk Instrument Making Plant Novosibirsk, Russian
Federation.
RECALLED BY Intertech (Advanced International Technologies), North
Kingstown, Rhode Island (importer). FDA approved the firm's
corrective action plan May 17, 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 79 units.
REASON Products emitted x-radiation that is unnecessary to the
accomplishment of the purpose of the product, and creates a
risk of injury to users.
_______________
PRODUCT Polycitra K Crystals, (potassium citrate and citric acid for
oral solution), with Maintenance propHilter Urinary pH
Testing Kit (envelope) consisting of a one month diary, and
urinary pH indicator test strips packaged in a folding
carton containing 100 packets of the Polycitra Crystals, and
Polycitra K Crystals (potassium citrate and citric acid for
oral solution) propHiler Urinary pH Testing Kit (envelope
consisting of four starter samples of Polycitra K Crystals,
two week Progress Diary, information brochure titled
"Preventing Kidney Stone Recurrence with Polycitra K, and
urinary pH indicator test strips, an alkalinizing agent for
control of uric acid and cystine calculi of the urinary
tract.
Recall #Z-929-4.
CODE All maintenance propHiler Kit lots shipped from 4/5/93 to
2/17/94.
-8- MANUFACTURER Baker Norton Pharmaceuticals, Inc., Miami, Florida, by
letter March 4, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 17,138 (10/100 packet) cases, and a small
quantity of physician starter samples.
REASON The urinary test kit component is considered to be
misbranded as the pH indicator test strips included do not
have 510(k) approval.
_______________
PRODUCT Sorin BCD ADV C Blood Cardioplegia Delivery Sets, designed
to mix arterial blood from an oxygenator with asanquineous
cardioplegic solution, and deliver it to the patient.
Recall #Z-941-4.
CODE Lot numbers for BCD ADV C sets sold individually, packed in
cartons:
9300120300 9300168800 9300312800 9400132200
9300144300 9300255400 9400102300 9400140900
9300152200 9300288400 9400111100 9400122300
Lot numbers for BCD ADV C sets within SCPS kits:
SCPS Lot Numbers: BCD ADV C Lot Numbers:
OMS4982-4983 9400139700 9300288400 9400140900
9300328600 9400168700 9300312800 9400102300
9400114900 9400170700
9400128900 9400170600
9400139600
Lot numbers for BCD ADV C sets within PTS kits within SCPS
kits:
SCPS Lot Numbers: PTS Lot Numbers: BCD ADV C Lot Numbers:
9400177600 9400128800 9400122300
9400108700 9300308600 9300255400
OMS-5166.
MANUFACTURER Sorin Biomedical, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter April 22, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, California, Florida, Illinois, Indiana, Michigan,
Mississippi, North Carolina, New Mexico, Ohio, Oklahoma,
Pennsylvania, Tennessee, Texas, Utah, Washington state,
Wisconsin, West Virginia, Canada, Korea.
QUANTITY Approximately 5,116 units were distributed; firm estimated
500-700 units remained on market at time of recall.
REASON The blood lines and cardioplegia solution lines for an
unknown number of devices across several device lots were
reversed, resulting in an incorrect blood to cardioplegia
solution configuration.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT L-Cath Procedural Tray for L-Cath Peel Away Placement Sets
with Catheter Extension Set:
(a) L-Cath Procedural Tray Prod. No. PE16PIC20K;
-9- (b) L-Cath Procedural Tray Prod. No. PE18PIC20K;
(c) L-Cath Procedural Tray Prod. No. PE20PIC20K;
(d) L-Cath Procedural Tray Prod. No. PE16PIC56K;
(e) L-Cath Procedural Tray Prod. No. PE18PIC56K;
(f) L-Cath Procedural Tray Prod. No. PE20PIC56K;
(g) L-Cath Procedural Tray Prod. No. PIC-03;
(h) L-Cath Procedural Tray Prod. No. PIC-03A.
Recall #Z-877/884-4.
CODE All lot numbers of the PIC-03 or PIC-03A procedural trays
either sold separately or in kit form. All product numbers
involved.
MANUFACTURER Tri-State Hospital Supply Corporation, Howell, Michigan.
RECALLED BY Luther Medical Products, Inc, Tustin, California (own label
distributor/responsible firm), by letters of December 2 and
15, 1993. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 4,479 trays were distributed; firm estimates none remains on
the market.
REASON The male luer of the extension set leaks.
_______________
PRODUCT Stratus Free Thyroxine FT4 Fluorometric Enzyme Immunoassay
Kit IVD, intended for the determination of free thyroxine
concentrations in serum or plasma. Recall #Z-892-4.
CODE Kit catalog #B5700-48, lot #KXT4-869M.
MANUFACTURER Baxter Diagnostics, Inc., Miami, Florida. With the
exception of the substrate (manufactured at the Aguada,
Puerto Rico Facility) all components were made at the Miami
plant.
RECALLED BY Baxter Diagnostics, Inc., Miami, Florida, by telephone
November 1-3, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Argentina.
QUANTITY 107 kits were distributed.
REASON The antibody tabs did not have spotting solution and were
not imprinted with a lot number.
_______________
PRODUCT Stratus Ultra-Sensitive hTSH Enzyme Immunoassay Kits,
intended for the determination of human thyroid stimulating
hormone (hTSH) concentrations in serum or plasma.
Recall #Z-893-4.
CODE Catalog #B5700, Kit lots KXS-24M through KXTS-322M, except
KXTS-229M and KXTS-252M.
MANUFACTURER Baxter Diagnostics, Inc., Aguada, Puerto Rico.
RECALLED BY Baxter Diagnostics, Inc., Miami, Florida, by letter dated
October 1993, mailed October 20, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 31,000 kits.
-10- REASON One of the kit components, the Ultra-Sensitive hTSH
Conjugate, may have contained aggregates that could cause
calibrator, control, or patient sample values to be higher
than they should have been.
_______________
PRODUCT Deknatel Custom Procedure Pak, V-Pak suture sleeve which
includes 11 different products packaged in sealed Tyvek
pouch. Recall #Z-894-4.
CODE Catalog #V-2307, lot #02591.
MANUFACTURER Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY Manufacturer, by letter March 18, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Arkansas.
QUANTITY 60 pouches were distributed.
REASON Some of the individual pouches did not contain the needles
labeled.
_______________
PRODUCT Cottony II Dacron Orthopaedic Non-Absorbable Surgical Suture
Green. Recall #Z-895-4.
CODE Catalog #89-5039M5, lot #02447.
MANUFACTURER Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY Manufacturer, by telephone, followed by letter March 18,
1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Utah, Georgia.
QUANTITY 132 pouches were distributed.
REASON The primary suture package (carrier) may be incorrectly
labeled as Product Code 89-5032M5.
_______________
PRODUCT Custom Procedure Pak Non-Absorbable Surgical Suture, 5
green, 5 white braided surgical sutures packaged in a V-Pack
suture sleeve. Recall #Z-896-4.
CODE Catalog #VF69-7101 GW, lot #02291.
MANUFACTURER Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY Manufacturer, by telephone, followed by letter March 18,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin, Florida, Utah, Canada.
QUANTITY 175 pouches were distributed.
REASON The shelf box and pouch labels identify the pledgets that
are stitched onto the suture as "soft", when they are
actually "firm".
_______________
PRODUCT Arthrex Tunnel Notcher, used in arthroscopic surgery,
Catalog #AR-1844. Recall #Z-924-4.
CODE All units manufactured with a design that has a visible
outline of the notch within the shaft where the notch is
brazed onto the shaft.
MANUFACTURER Ultrexx, Inc., Ultra Precision Machining, Avilla, Indiana.
-11- RECALLED BY Arthrex, Inc., Naples, Florida, by letter sent during the
first week of November 1993. Firm-initiated recall
complete.
DISTRIBUTION California, Texas, Tennessee, Maryland, New York, Virginia,
Michigan, Arizona, Florida, Colorado.
QUANTITY 103 units were distributed.
REASON A piece of the tunnel notcher, the part that cuts the notch,
can break off from the rest of the device.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Spot Balm, in 2 fluid ounce plastic bottles, liquid topical
OTC animal drugs containing sulfanilamide. Recall #V-052-4.
CODE Lot numbers: 120192, 30193, 40193, 60193, 80193, 90193,
100193.
MANUFACTURER Happy Jack, Inc., Snow Hill, North Carolina.
RECALLED BY Manufacturer, by letter dated February 9, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 615 bottles of lot 120192, 622 bottles of lot 30193, 624
bottles of lot 40193, 626 bottles of lot 60193, 626 bottles
of lot 80193, 625 bottles of lot 90193, 449 bottles of lot
100193.
REASON No assurance that the product met labeled specifications for
potency of the active ingredient (sulfanilamide).
SEIZURES:
=================================================================
_______________
PRODUCT Canned Chunk Light Tuna in Spring Water (93-651-183).
CHARGE Misbranded - The article purports to be and is represented
as canned tuna, a food for which a standard fill of
container has been prescribed, and the article falls below
such standard.
LOCATION Starkist Foods, Inc., doing business as Heinz Pet Products,
Pascagoula, Mississippi.
FILED March 29, 1994; U.S. District Court for the Southern
District of Mississippi, Southern Division;
Civil #1:94cv164RR; FDC #66927.
SEIZED April 4, 1994 - goods valued at approximately
$152,000.
_______________
PRODUCT Canned Tuna in Water (94-656-773/4).
CHARGE Adulterated - The articles consist in part of decomposed
seafood.
LOCATION The Belt's Corporation, Baltimore, Maryland.
FILED May 6, 1994; U.S. District Court for the District of
Maryland; Civil #HAR-94-1199; FDC #66956.
SEIZED May 20, 1994 - goods valued at approximately $73,000.
-12- _______________
PRODUCT Oxygen, USP (93-607-680).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the article's manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements for drugs.
LOCATION Butler Gas Products Co., New Brighton, Pennsylvania.
FILED May 5, 1994; U.S. District Court for the Western
District of Pennsylvania; Civil #94-0743; FDC #66958.
SEIZED May 17, 1994 - goods valued at approximately $10,000.
_______________
PRODUCT Oxygen, USP (93-713-727).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the article's manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
LOCATION Metro-Med, Inc., Burbank, California.
FILED May 5, 1994; U.S. District Court for the Central District
of California; Civil #94-2939RSWL(GHKx); FDC #66946.
SEIZED May 12, 1994 - goods valued at approximately $50,000.
_______________
PRODUCT Oxygen, USP (93-607-839).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the article's manufacture, processing,
packing, and holding do not conform to and are not operated
and administered in conformity with current good
manufacturing practice requirements.
LOCATION Medi-Home-Care, Butler, Pennsylvania.
FILED April 15, 1994; U.S. District Court for the Western
District of Pennsylvania; Civil #94-0620; FDC #66904.
SEIZED May 17, 1994 - goods valued at approximately $3,500.
-13-
END OF ENFORCEMENT REPORT FOR JUNE 15, 1994. BLANK PAGES MAY FOLLOW.
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