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
04/06/1994
Recalls and Field Corrections: Drugs -- Class II -- 04/06/1994
APRIL 6, 1994 94-14
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Food Industry Sanitizing Soap (GOJO), distributed under ten
(10) private labels and product names in addition to the
firm's GOJO brand; and is packaged in five (5) different
sizes as follows:
1. GOJO brand E-2 Food Industry Sanitizing Soap, in 800 ml
cartridges, 1000 ml cartridges, 2000 ml cartridges, 5000 ml
cartridges, and in 4 ounce bottles;
2. Easterday Janitorial Supply brand E-2 Germicidal Soap
Plus, in 1000 ml cartridges, 6 units per case;
3. Hillyard Chemical brand E-2 Plus Food Industry
Sanitizing Soap, in 4 ounce bottles, 12 units per case; 1000
ml cartridges, 6 units per case; 2000 ml cartridges, 4 units
per case;
4. Peninsular Paper brand E-2 1000 Food Industry Sanitizing
Soap in 1000 ml cartridges, 6 units per case;
5. North American Paper brand Spectrum E-2 Food Industry
Sanitizing Soap, in 1000 ml cartridges, 6 units per case;
6. Penn Jersey brand Sanitary Supply Sani-Soap Food
Industry Sanitizing Soap, in 1000 ml cartridges, 6 units per
case;
7. Massco brand Food Prep Sanitizing Soap, in 1000 ml
cartridges, 6 units per case;
8. SourceOne brand E-2 Food Industry Sanitizing Soap, in
1000 ml cartridges, 6 units per case;
9. International Distribution System (IDS), brand E-2 Food
Industry Sanitizing Soap, in 1000 ml cartridges, 6 units per
case, 5000 ml cartridges, 6 units per case;
10. Selig Chemical Industries brand Sootho Food Processing
Sanitizing Lotion Soap E-2, in 800 ml cartridge, 12 units
per case;
11. Zep Manufacturing brand, Handstand TM E-2 Hand Soap, in
800 ml cartridges, 12 units per case. Recall #D-221-4.
CODE Batch numbers: 91537, 92357, 05475, and 12778.
MANUFACTURER GOJO Industries, Inc., Cuyahoga Falls, Ohio.
RECALLED BY Manufacturer, by letter March 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,100 cases were distributed.
REASON Presence of Pseudomonas cepacia and Serratia marcescens.
_______________
PRODUCT Various Rx injectable drug products, 25 vials per tray:
(a) Aminophylline Injection, USP, 25 mg/ml, 100 ml vials,
pharmacy bulk pack; for IV use only after dilution for the
relief of acute bronchial asthma;
(b) Clindamycin Phosphate Injection, USP, 150 mg/ml, a
semisynthetic antibiotic for IM or IV use for the treatment
of serious infections caused by susceptible anaerobic
bacteria; 2 ml vials, 4 ml vials, 6 ml vials;
(c) Glycopyrrolate Injection, USP, 0.2 mg/ml, an
anticholinergic for the use as a preoperative antimuscarinic
to reduce salivary, tracheobronchial and pharyngeal
secretions, 1 ml vials, 2 ml vials, 5 ml vials, 20 ml vials;
(d) Heparin Sodium Injection, USP, for anticoagulant therapy
in prophylaxis and treatment of venous thrombosis and the
prevention of postoperative deep venous thrombosis and
pulmonary embolism: 1000 USP units/ml 10 ml vial, 30 ml
vials, (private label) - Rx/Dx Hemochron Heparin Sodium
Injection, USP, 1,000 USP units/ml, 10 ml multiple dose
vial, Manufactured for International Technidyne Corp.,
Edison, NJ; 10,000 USP units/ml 5 ml vials;
(e) Heparin Lock Flush Solution, USP, 10 units/ml, for the
maintenance of patency of an indwelling venipuncture device
designed for intermittent injection of infusion therapy or
blood sampling 10 ml vial, 30 ml vials;
(f) MVC 9 + 3 Multivitamin Concentrate, a daily multivitamin
dosage for adults and children aged 11 and above receiving
parenteral nutrition (for infusion after dilution) 10 ml
covial, 50 ml vials;
(g) Potassium Chloride Injection Concentrate, USP, 2 mEq/ml,
IV infusion after dilution for the treatment potassium
deficiency states when oral replacement is not feasible; 100
ml vial, 200 ml vials;
-2- (h) Sterile Cefazolin Sodium, USP, a semisynthetic
cephalosporin antibiotic for parenteral administration for
the treatment of respiratory tract infections, genital tract
infections and other serious infections due to susceptible
organisms: 500 mg, 10 ml vial, 100 ml vial; 1 g, 10 ml
vial, 100 ml vial; 10 g, 100 ml vial;
(i) Vincristine Sulfate Injection, USP, 1 mg/ml, used for
the treatment of acute leukemia; 1 ml vial; 2 ml vial,
5 ml vial. Recall #D-222/233-4.
CODE All lots within expiration date. (Note: Cefazolin Sodium
products with lot numbers ending in "A" are not subject to
recall).
MANUFACTURER Lyphomed/Fujisawa USA, Inc., Melrose Park, Illinois
(products a, b, c, f, g, i).
Lyphomed/Fujisawa USA, Inc., Grand Island, New York
(products d, e, h).
RECALLED BY Fujisawa USA Deerfield, Illinois, by letter March 7, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Aminophylline - Nationwide; Clindamycin - Nationwide, Malta,
Qatar; Glycopyrrolate - Nationwide; Heparin - Nationwide,
Israel, Chile, Mexico, Palau, and the Bahamas;
MVC 9+3 - Nationwide and international;
Potassium Chloride - Nationwide and Israel;
Cefazolin - Nationwide and New Zealand;
Vincristine - Nationwide and Belize.
QUANTITY 5,400 vials of aminophylline, 50,600 vials of clindamycin,
3,833,220 vials of glycopyrrolate, 3,575,075 vials of 1,000
unit heparin, 1,011,775 vials of 10,000 unit heparin,
452,300 vials of heparin lock flush, 818,325 vials of MVC
9+3, 520,700 vials of potassium, 197,200 vials of 500 mg
cefazolin, 743,990 vials of 1 g cefazolin, 27,450 vials of
10 g cefazolin, and 56,544 vials of vincristine were
distributed, with the firm estimating that 15-20% of the
product remains on the market.
REASON Abbreviated New Drug Application/Abbreviated Antibiotic
Ddrug Application discrepancies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Bisacodyl Tablets, 5 mg, nonprescription laxative.
Recall #D-220-4.
CODE 54073B and 53073B.
MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone and by letter February 6, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Minnesota, New Jersey.
QUANTITY 485,697 tablets of lot 54073B and 323,798 tablets of lot
53073B were distributed.
REASON Use of non-food grade ink on tablets. Ink manufacturer
responsible for error.
-3- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ---------------------
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-165/166-4.
CODE Unit numbers: (a) 04G43485, 04G43488, 04G43491, 04G43492,
04G43493, 04G43495, 04G43497, 04G43499, 04G43501, 04G43502,
04G43503, 04G43504, 04G43505, 04G43506, 04G43507, 04G43508,
04G43511, 04G43512, 04G43513, 04G43514, 04G43515, 04G43516,
04G43518, 04G43519, 04G43521, 04G43523, 04H91883, 04H91885,
04H91886, 04H91887, 04H91891, 04H91892, 04H91893, 04H91894,
04H91895, 04H91896, 04H91898, 04H91899, 04H91901, 04H91903,
04H91906, 04H91908, 04H91909, 04H91910, 04H91914, 04H91916,
04H91918, 04H91920, 04H91922, 04H91924, 04H91925, 04H91926,
04H91927, 04H91928, 04H91930, 04H91931, 04H91932, 04H91933,
04H91936, 04H91940, 04H91941, 04H91942, 04H91946, 04H91947,
04H91949, 04H91950, 04H91951, 04H91952, 04H91953, 04H91954,
04H91957, 04H91958, 04H91960, 04H91961, 04H91962, 04H91963,
04H91964, 04H91965, 04GF18083, 04GF18084, 04GF18085,
04GF18087, 04GF18089, 04GF18090, 04GF18091, 04GF18092,
04GF18095, 04GF18096, 04GF18097, 04GF18101, 04GF18104,
04GF18105, 04GF18106, 04GF18108, 04GF18109, 04GF18110,
04GF18113, 04GF18114, 04GF18117, 04GF18120, 04GF18122,
04GF18123, 04GF18125, 04GF18127, 04GF18128, 04GF18130,
04GF18135, 04GF18137;
(b) 04G43485, 04G43488, 04G43489, 04G43491, 04G43492,
04G43493, 04G43494, 04G43495, 04G43497, 04G43499, 04G43501,
04G43511, 04G43512, 04G43513, 04G43515, 04G43516, 04G43517,
04G43518, 04G43519, 04G43521, 04G43522, 04G43523, 04H91886,
04H91888, 04H91891, 04H91892, 04H91893, 04H91894, 04H91895,
04H91896, 04H91897, 04H91902, 04H91903, 04H91904, 04H91905,
04H91906, 04H91907, 04H91908, 04H91909, 04H91911, 04H91912,
04H91913, 04H91915, 04H91916, 04H91917, 04H91918, 04H91920,
04H91922, 04H91924, 04H91928, 04H91930, 04H91931, 04H91933,
04H91936, 04H91939, 04H91941, 04H91942, 04H91944, 04H91945,
04H91946, 04H91947, 04H91949, 04H91950, 04H91952, 04H91953,
04H91954, 04H91956, 04H91959, 04H91960, 04H91963, 04H91965,
04H91966, 04GF18081, 04GF18083, 04GF18086, 04GF18087,
04GF18088, 04GF18090, 04GF18093, 04GF18099, 04GF18100,
04GF18102, 04GF18104, 04GF18106, 04GF18107, 04GF18108,
04GF18110, 04GF18111, 04GF18112, 04GF18116, 04GF18117,
04GF18118, 04GF18119, 04GF18121, 04GF18125, 04GF18127,
04GF18128, 04GF18130, 04GF18131, 04GF18133, 04GF18134,
04GF18136.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone July 10, and 15, 1991, and by
letter July 24, 1991. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maine.
QUANTITY (a) 108 units; (b) 102 units.
REASON Blood products incorrectly tested for syphilis were
distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-188-4.
CODE Unit #28027-4218.
-4- MANUFACTURER United Blood Services Blood Systems, Inc., San Angelo,
Texas.
RECALLED BY Manufacturer, by letter March 31, 1993. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Red Blood Cells, collected from a donor who had visited an
area endemic for malaria and had taken prophylactic anti-
malarial medication two years prior to donation, were
distributed.
_______________
UPDATE The February 9th Enforcement Report identified Wheaton
Tubing Products ("Wheaton") as the manufacturer of recalled
sterile glass vials for use with diluents and allergenic
extracts (Recall #B-140/141-4). Although the glass vials, a
component of the final product, were supplied by Wheaton,
the manufacturer is Allergy Laboratories, Inc. The
Enforcement should have identified Allergy Laboratories,
Inc. as both the recalling and manufacturing firm of the
final distributed product.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-167/168-4.
CODE Unit numbers: (a) 04C05639, 04C05640, 04C05643, 04C05644,
04C05649, 04C05652, 04C05653, 04C05654, 04C05655, 04C05657,
04J21634, 04N84567, 04N84568, 04N84572, 04N84576, 04N84578,
04R64824, 04R64833, 04W68142, 04FS12369, 04FS12372,
04FS12373, 04FS12375, 04FS12379, 04FS12381, 04FS12382,
04FS12385, 04FS12392, 04FS12397, 04FS12407, 04FS12413,
04FS12414, 04FS12415;
(b) 04J21629, 04J21630, 04J21631, 04J21633, 04J21634,
04M01140, 04M01141, 04M01143, 04M01144, 04M01145, 04M01146,
04M01152, 04M01155, 04M01156, 04M01158, 04M01161, 04M01164,
04N84567, 04N84568, 04N84572, 04N84573, 04N84578, 04N84581,
04R64795, 04R64800, 04R64801, 04R64806, 04R64814, 04R64815,
04R64817, 04R64822, 04R64826, 04R64828, 04R64829, 04R64830,
04R64831.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY Manufacturer, by telephone July 10 and 15, 1991, followed by
letter July 24, 1991. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Maine.
QUANTITY (a) 33 units; (b) 36 units.
REASON Blood products incorrectly tested for syphilis were
distributed.
-5- _______________
PRODUCT Source Plasma. Recall #B-185-4.
CODE Unit numbers: C05877-109 through C05896-109, C05898-109
through C05908-109, C05910-109 through C05912-109,
G26345-109 through G26369-109, G26371-109 through
G26399-109, G26401-109 through G26417-109,
G26419-109 through G26421-109, G26423-109 through
G26463-109, G26465-109 through G26531-109,
G26533-109 through G26536-109, G26538-109 through
G26547-109, G26549-109 through G26572-109,
G26574-109 through G26621-109, G26624-109 through
G26682-109, G26684-109 through G26711-109,
K05023-109 through K05028-109.
MANUFACTURER San Juan Plasma, Inc., Farmington, New Mexico.
RECALLED BY Manufacturer, by letter August 17, 1993, and by telephone
March 7, 1994. Firm-initiated recall complete.
DISTRIBUTION California, Massachusetts.
QUANTITY 395 units.
REASON Source Plasma, exposed to elevated storage temperatures and
not properly relabeled as Source Plasma, Salvaged, was
distributed.
_______________
PRODUCT Platelets. Recall #B-186-4.
CODE Unit #C24894.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
RECALLED BY Manufacturer, by telephone September 27, 1993, followed by
letter September 29, 1993. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for hepatitis
B surface antigen (HBsAg) by EIA, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-187-4.
CODE Unit #1M99786.
MANUFACTURER Community Blood Center of Mercer County, Trenton, New
Jersey.
RECALLED BY Manufacturer, by telephone June 1, 1993. Firm-initiated
recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product, which was labeled with the incorrect
expiration date, was distributed.
_______________
PRODUCT (a) Whole Blood; (b) Platelets, Pheresis; (c) Red Blood
Cells; (d) Platelets; (e) Recovered Plasma.
Recall #B-189/193-4.
CODE Unit numbers: (a) 1075092; (b) 2604250; (c-e) 8100569.
MANUFACTURER LifeSource, Glenview, Illinois.
-6- RECALLED BY Manufacturer, by letters of January 17 and 18, 1994. Firm-
initiated recall complete.
DISTRIBUTION Illinois, New York.
QUANTITY 1 unit of each component.
REASON Blood products which tested reactive to serologic test for
syphilis were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT I.V. Administration Sets: (a) "Mini Set", Order #28-60-125,
designed to connect to the extension set used with the
Siemens Infusion System, contained in a cardboard box, 20
per box;
(b) "Uni Set", Order #28-60-265, used with the Siemens
Infusion System. The product has two Y-sites with a check
valve, it's priming volume is approximately 16 ml, packaged
in a plastic pouch, contained in a cardboard box, 70 per
box;
(c) "Custom Set", Order #25-25-01, same as "Uni Set" with
the exception that this product contains a filter which
renders the custom name. In addition, the priming volume is
approximately 26 ml. Recall #Z-787/789-3.
CODE Lot numbers: (a) Q1470 AND Q1501; (b) Q1720;
(c) Q1721, Q1729, Q1733, Q1737.
MANUFACTURER Siemens Infusion Systems, Sylmar, California.
RECALLED BY Manufacturer, by letters of April 20, 1993, May 12 and 19,
1993. Firm-initiated recall ongoing.
DISTRIBUTION (a) California, Illinois, Texas, Virginia, Florida, North
Carolina, New Jersey, Virginia, Illinois; (b) Illinois; (c)
Illinois, Kentucky, Missouri, Mississippi, North Carolina,
New Jersey, Texas, Virginia, West Virginia, California,
Hawaii, Minnesota, Montana, Oklahoma, Tennessee, Wisconsin,
Indiana.
QUANTITY (a) 1,800 units of lot Q1470, 6,120 units of lot Q1501; (b)
840 units of lot Q1720; (c) 2,170 units of lot Q1721, 6,090
units of lot Q1729, 18,1690 units of lot Q1733, 14,210 units
of lot Q1737.
REASON The Mini-Set was manufactured with a 12" Macrobore upper
tubing section instead of a Microbore upper tubing section
as labeled which also increases the priming volume by
approximately 1 ml. The custom set and Uni set have kinking
tubing and pinholes that may compromise package integrity.
_______________
PRODUCT Hafcon brand Head Activated Fluoroscopic Controller,
mechanism for regulating fluoroscopic infared light
transmitters. Recall #Z-297-4.
CODE All serial numbers.
MANUFACTURER Electrotechnics, Corporation, Shreveport, Louisiana.
RECALLED BY Manufacturer, December 7, 1993. Firm-initiated recall
ongoing.
-7- DISTRIBUTION Louisina Indiana, Ohio, Texas, Virginia.
QUANTITY 35 units.
REASON The firm does not have any manufacturing documents showing
that the product was made to specification.
_______________
PRODUCT IVAC Needleless IV Sets, used for the administration of IV
solutions. Recall #Z-301-4.
CODE All lots.
MANUFACTURER IVAC Corporation, San Diego, California.
RECALLED BY Manufacturer, by telephone November 18, 1994. Firm-
initiated recall complete.
DISTRIBUTION California, Kansas, Ohio, South Carolina, Utah, Canada,
England, France, New Zealand.
QUANTITY 13,900 units were distributed.
REASON Leaking caused by defective manufacturing material.
_______________
PRODUCT Cobe Centry System 3 Blood Tubing Set, Catalog #003110-500.
Recall #Z-302-4.
CODE Lot numbers: 07Y15317, 07Y15318.
MANUFACTURER CGH Medical, Inc., Tijuana, Mexico.
RECALLED BY Cobe Renal Care, Inc., Lakewood, Colorado, by telephone
November 9, 1993, and November 30 through December 3, 1993,
followed by letter February 11, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Bermuda, Santiago, Chile, Taiwan.
QUANTITY 21,390 sets were distributed.
REASON The solvent used to bond the tubing with the luer was
contaminated with alcohol during manufacturing due to a
manufacturing operator error which could result in a
disconnection of the tubing at the luer.
_______________
PRODUCT Ohmeda Rascal II Anesthetic Gas Monitor, a dedicated
respiratory gas monitoring system that identifies anesthetic
agents and measures inspired and expired oxygen as well as
nitrogen. Recall #Z-303-4.
CODE Serial numbers: FZAU00001 to FZAU00394, FZAV00395 to
FZAV00886 to FZAW00887 to FZAW01697, with software versions
1.10 or lower.
MANUFACTURER Ohmeda Medical Systems Division, Salt Lake City, Utah.
RECALLED BY Ohmeda Medical Systems Division, Madison, Wisconsin, by
letters dated January 17 and 18, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 1,222 units were distributed.
REASON The anesthetic gas monitoring equipment could misidentify
the anesthetic gas after long periods of continuous use, and
if the misidentification involves halothane, the displayed a
concentrate could be twice the actual concentration, due to
a defect with software version 1.10 or lower.
-8- _______________
PRODUCT Baxter Auto Syringe Model AS40A Infusion Pump, product code
1M8565, Rx medical device used for accurate continuous or
intermittent infusion delivery of fluids and drugs via
intravenous, intra-arterial, epidural, or subcutaneous
routes of administration. Recall #Z-305-4.
CODE All units with D1 or D2 decal adjacent to the serial number.
MANUFACTURER Baxter Healthcare Corporation PTE Ltd., Singapore.
RECALLED BY Baxter Healthcare Corporation, I.V. Systems Division, Round
Lake, Illinois, by letters dated February 14, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,993 units were distributed.
REASON The infusion pump's optional drug library contains drug
delivery protocols which may be in conflict with the drug
manufacturers' package insert protocols for the drugs.
Confusion over and misinterpretation of various protocols
presented in the insert and in the drug library could result
in over infusion or under infusion of fluids/medications.
Also, concentration of fluids could be faulty.
_______________
PRODUCT Stryker Auxiliary Video Organizer, Catalog #240-085-000.
Recall #Z-306-4.
CODE All serial numbers.
MANUFACTURER Stryker Endoscopy, San Jose, California.
RECALLED BY Manufacturer, by letter March 25, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 9 carts.
REASON The bottom frame of the cart was bent.
_______________
PRODUCT Gonochek II, used for in-vitro diagnostic for the rapid
identification of pathogenic Neisseria species.
Recall #Z-372-4.
CODE Product code 13-003-25.
MANUFACTURER EY Laboratories (HK), Ltd., Tsuen Wan, New Purritories, Hong
Kong.
RECALLED BY EY Laboratories, Inc., San Mateo, California, December 17,
1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,845 tests.
REASON The test will result in a false negative result when used
for isolates of Neisseria species grown on certain media.
_______________
PRODUCT Epics Brand Cytometers and Dye Laser:
(a) Epics C Series Flow Cytometer; Catalog Nos. 6602370,
6602808, 6603235, 6602741, 6603376, 6602809, 6602812,
6602813, 6603365, 6603375, 6603534/6603538, 6603440,
6603530/6603533, 6603670;
-9- (b) Epics 500 Series Flow Cytometer; Catalog Nos.
6602837, 66022838, 6603207, 6603102/6603104,
6603489/6603493;
(C) Epics 700 Series Flow Cytometer; Catalog Nos. 6602666,
6602669, 6602674, 6602121, 6602317, 6602557,
6603166/6603168, 6603430, 6603669, 6603054, 6603666,
6603169, 6603171, 6603431, 6603187, 6603246, 6603247,
6603248, 6603432, 6602645, 6602661, 6603172, 6603173,
6603433, 6603655;
(d) Epics Dye Laser; Catalog No. 6603234;
(e) Epics IV Flow Cytometer; Catalog Nos. 6601394,
6602295;
(f) Epics V Flow Cytometer; Catalog Nos. 6601395, 6601396,
6602541;
(g) Epics Elite Flow Cytometer; Catalog Nos.
6604042/6604045. Recall #Z-381/387-4.
CODE All serial numbers.
MANUFACTURER Coulter Corporation, Epics Group, Miami Lakes, Florida.
RECALLED BY Coulter Corporation, Miami Florida, by letter January 21,
1992. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON There is a potential for electrical shock which may result
into burns to the operator.
_______________
PRODUCT LC Jet D Disposable Nebulizer used to administer/inhale a
prescribed dosage of medication. Recall #Z-461-4.
CODE Lot #011293.
MANUFACTURER Paul Ritzau Pari-Werk, GmbH, Starnberg, Germany.
RECALLED BY Pari Respiratory Equipment, Inc., Richmond, Virginia, by
telephone January 26 and 27, 1994, followed by letter dated
January 28, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,302 units were distributed.
REASON A portion of the dose of the drug is ejected as small
droplets through the filler port at the top of the device
rather than being nebulized out the side of the device as
intended.
_______________
PRODUCT Model MGU-10A Mammography System, used for mammographic
studies. Recall #Z-465-4.
CODE None.
MANUFACTURER Toshiba Corporation, Tokyo, Japan.
RECALLED BY Toshiba America Medical Systems, Inc., Tustin, California.
FDA approved the firm's corrective action plan March 29,
1994. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11 units.
-10- REASON Device failed to comply with the Federal Performance
Standard for Diagnostic X-Ray System and their major
components for user information as required.
_______________
PRODUCT Stiegmann-Goff Endoscopic Ligator Kits, for endoscopic
ligation of varices and hemorrhoids:
(a) Stiegmann-Goff Endoscopic Ligator, Catalog #200220 (5
bands);
(b) Stiegmann-Goff Endoscopic Ligator, Catalog #200221 (10
bands);
(c) Stiegmann-Goff Endoscopic Ligator, Catalog #200219, 1
per box. Recall #Z-529/531-4.
CODE All lots.
MANUFACTURER Superior Health Care Group, Inc., Cumberland, Rhode Island.
RECALLED BY Bard Interventional Products, Tewksbury, Massachusetts, by
letter December 3, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 37,710 ligators and 3,414 overtubes were distributed.
REASON No 510(k) has been filed for the Esophageal use of the
ligator and no 510(k) was filed for the overtube used as an
accessory to the endoscopic procedure.
_______________
PRODUCT Allergan Medical Optics (AMO) Prestige Pack Disposable
Tubing Sets:
(a) Model OPO-30S Phaco I/A Tubing Set, Small Bore, provides
items necessary to perform one irrigation/aspiration
procedure or one phacoemulsification procedure with AMO
cataract equipment;
(b) Model OPO-30C Phaco I/A Tubing Set, provides items
necessary to perform one irrigation/aspiration procedure or
one phacoemulsification procedure with AMO cataract
equipment;
(c) Model OPO-40, Phaco I/A Tubing Set, provides items
necessary to perform one irrigation/aspiration procedure or
one phacoemulsification procedure with AMO prestige advanced
cataract extraction system. Recall #Z-532/534-4.
CODE All lots manufactured since 12/91 as follows: M8514, M8517,
M2566, M8679, M9247, M9350, M9365, M9527, M9558, M9559,
M9700, M9725, M9753, M9915, M10217, M10279, M10375, M11074,
M11192, M11221.
MANUFACTURER Allergan Medical Optics, subsidiary of Allergan, Inc.,
Lenoir City, North Carolina.
RECALLED BY Allergan Medical Optics, Division of Allerlgan, Inc.,
Irvine, California, by telephone November 9, 1993, followed
by letter November 10, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 175,790 sets; (b) 12,036 sets; (c) 390 sets were
distributed; firm estimates the following amounts remain on
the market: (a) 7,324 sets; (b) 1,504; (c) 97.
-11- REASON Cracks have been found on outer trays used to package
sterile tubing sets. The cracks result from excessive
brittleness of the high-impact polystyrene after gamma
irradiation, therefore compromising the sterility of the
tubing product inside the package.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT SMA Reference Reagent, intended for in-vitro diagnostic use
in the calibration of SMA analyzers. Recall #Z-443-4.
CODE Lot #181180 EXP 6/94.
MANUFACTURER Amresco, Inc., Solon, Ohio.
RECALLED BY Manufacturer, by telephone September 3, 1993, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION California, North Dakota, Canada.
QUANTITY 100 vials.
REASON The device was found to have been assigned an incorrect lot
number.
_______________
PRODUCT NAMIC Angiographic Guidewires, intended for use in the
percutaneous introduction of catheters:
(a) Catalog #96000105; (b) Catalog #96000106; (c) Catalog
#96000204; (d) Catalog #96000207; (e) Catalog #96000208;
(f) Catalog #96000209. Recall #Z-444/449-4.
CODE Lot numbers: (a) 01-043580; (b) 01-043564; (c) 01-043512,
02-043512; (d) 01-043568, (e) 01-043569, (f) 01-043555.
MANUFACTURER Lake Region Manufacturing Company, Inc., Chaska, Minnesota.
RECALLED BY NAMIC (North American Instrument Company), Glens Falls, New
York, by telephone January 11, 1993, followed by letter
January 12, 1994. Firm-initiated recall ongong.
DISTRIBUTION Nationwide and international.
QUANTITY 5,575 units were distributed.
REASON Labeling does not correctly identify the shape of the tip.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
============
_______________
PRODUCT (a) Phase II Horse Feed; (b) Phase III Horse Feed;
(c) Horse and Pony Feed. Recall #V-034/036-4.
CODE Manufacturing codes are dates of production: 11/9/93,
11/11/93, 11/23/93, 12/10/93, 1/14/94.
MANUFACTURER Molinos de Puerto Rico, Inc., Guaynabo, Puerto Rico.
RECALLED BY Manufacturer, by visit February 7, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Puerto Rico.
QUANTITY Horse and Pony Feed - 48,000 pounds; Phase Two and Phase
Three Horse Feed - 155,000 pounds.
REASON Possible cross-contamination of horse feed with monensin.
-12-
SEIZURES:
=================================================================
_______________
PRODUCT Love Land Food Supplement, Good News for Pets Food
Supplement, Love Land Conditioning Shampoo, Good News for
Pets Skin and Coat Treatment, accompanying labeling, and the
drug component precipitated sulfur (93-603-143/6).
CHARGES Adulterated - The articles are not generally reconized by
qualified experts as safe and effective for their intended
use and there are no approved applications in effect.
Misbranded - One of the articles is a drug which is
fabricated from two or more ingredients and its label fails
to bear the established name and quantity of each
ingredient, nor does it bear adequate directions for its
intended use for the treatment of dermatitis. All of the
articles were manufactured in an establishment not duly
registered and they were not included in a required list.
LOCATION Normera Resources Corporation, Syracuse, New York.
FILED February 15, 1994; U.S. District Court for the Northern
District of New York; Civil #94-CV-197(FJS); FDC #66903.
SEIZED March 11, 1994 - goods valued at approximately $22,000.
_______________
PRODUCT Oxygen USP, Helium USP, Nitrous Oxide USP, and Carbon
Dioxide USP (94-710-343, et al).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture and processing,
do not conform to and are not operated and administered in
conformity with current good manufacturing practice
regulation.
LOCATION BOC Airco Gases, Carol Stream, Illinois.
FILED March 29, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #94C 1948;
FDC #66937.
SEIZED March 29, 1994 - goods valued at approximately $195,000.
_______________
PRODUCT Love Land Food Supplement, Good News for Pets Food
Supplement, Love Land Conditioning Shampoo, Good News for
Pets Skin and Coat Treatment, accompanying labeling, and the
drug component precipitated sulfur (93-603-143/6).
CHARGES Adulterated - The articles are not generally reconized by
qualified experts as safe and effective for their intended
use and there are no approved applications in effect.
Misbranded - One of the articles is a drug which is
fabricated from two or more ingredients and its label fails
to bear the established name and quantity of each
ingredient, nor does it bear adequate directions for its
intended use for the treatment of dermatitis. All of the
articles were manufactured in an establishment not duly
registered and they were not included in a required list.
LOCATION Normera Resources Corporation, Syracuse, New York.
-13- FILED February 15, 1994; U.S. District Court for the Northern
District of New York; Civil #94-CV-197(FJS); FDC #66903.
SEIZED March 11, 1994 - goods valued at approximately $22,000.
_______________
PRODUCT Oxygen USP, Helium USP, Nitrous Oxide USP, and Carbon
Dioxide USP (94-710-343, et al).
CHARGE Adulterated - The methods used in, and the facilities and
controls used for, the articles' manufacture and processing,
do not conform to and are not operated and administered in
conformity with current good manufacturing practice
regulation.
LOCATION BOC Airco Gases, Carol Stream, Illinois.
FILED March 29, 1994; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #94C 1948;
FDC #66937.
SEIZED March 29, 1994 - goods valued at approximately $195,000.
-14-
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