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
03/22/1995
Recalls and Field Corrections: Foods -- Class I -- 03/22/1995
March 22, 1995 95-12
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Canned, acidified Chinese vegetables packed in 6 pound 6
ounce (#10) cans, 6 cans per case: (a) Bean Sprouts;
(b) Chop Suey Vegetables; (c) Chinese Mixed Vegetables.
Recall #F-503/505-5.
CODE All lots.
MANUFACTURER Worldwide Trading Company, doing business as Chinese Maid,
Inc., Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated March 8, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Illinois, Kentucky, Virginia, Indiana, Ohio, Wisconsin, New
York, Minnesota, California.
QUANTITY (a) 9,154 cases; (b) 4,113 cases; (c) 2,775 cases were
distributed.
REASON Products have the potential to support the outgrowth of
Clostridium botulinum toxin.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Bruce's Outrageous Star Cookies, 3.5 ounces, packaged in a
clear plastic wrap. Recall #F-506-5.
CODE None.
MANUFACTURER Bruce's Bakery, Great Neck, New York.
RECALLED BY Manufacturer, by telephone February 2, 1995, followed by
letter February 3, 1995. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY Firm estimates none remains on the market.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT (a) Apricot Strudel; (b) Apricot Rugallah; (c) Apricot
Hamantashen. Recall #F-507/509-5.
CODE None.
MANUFACTURER Irene's Bakery & Gourmet Kitchen, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone February 20, 1995. Firm-
initiated field correction (relabeling) complete.
DISTRIBUTION Pennsylvania, New Jersey.
QUANTITY (a) 4 pounds; (b) 4 pounds; (c) 6 pounds were distributed.
REASON Product contains undeclared FD&C Yellow #5.
_______________
PRODUCT Potato Salad and Pimento Spread: (a) Morehead and Shur Fine
brands Potato Salad, in 14 ounce retail size containers and
in 5 pound bulk containers for delicatessens;
(b) Morehead brand Pimento Spread, in 7-1/2 ounce, 14 ounce
and 24 ounce retail size containers and 5 pound bulk
containers for delicatessens; Shur Fine brand Pimento Spread
in 7-1/2 ounce and 14 ounce retail size containers.
Recall #F-510/511-5.
CODE (a) Morehead: 14 ounce - Pull Dates 03/06 and 03/13
Five pound - Pull Date 12/20 and 01/06
Shur Fine: 14 ounce - Pull Dates 02/20, 03/06 and 03/13
Pimento Spread: Morehead: 7 1/2 ounce - Pull Dates 4/18 and
05/02; 14 ounce - Pull Dates 04/18 and 05/02
24 ounce - Pull Dates 04/18 and 05/02
Five pound - Pull Dates 12/19 and 01/02
Shur Fine: 7 1/2 ounce - Pull Dates 04/18 and 05/02
14 ounce - Pull Dates 04/18 and 05/02.
MANUFACTURER Morehead Food Distributing Company, Amarillo, Texas.
RECALLED BY Manufacturer, by telephone January 16, 1995. Firm-initiated
recall complete.
DISTRIBUTION Kansas, New Mexico, Oklahoma, Texas, Colorado.
QUANTITY Firm estimates none remains on the market.
REASON The product may have been exposed to Hepatitis A by an
infected employee.
_______________
PRODUCT Fresh Asparagus from Peru with cases labeled in part "ICA
Premium" covered and AWB numbers 307-50458590 and 307-
50700020 was received from The Associacion de Productores De
Esparragus of ICA, Peru on 10/29/94 and 10/24/94.
Recall #F-517-5.
CODE None.
MANUFACTURER Associacion de Productores De Esparragus , Ica, Peru.
RECALLED BY Hillcrest, Inc., Medley, Florida, by letter November 4,
1994. Firm-initiated recall complete.
-2- DISTRIBUTION Florida, Illinois, Indiana, Michigan, Georgia, Pennsylvania,
Ohio, Canada.
QUANTITY Firm estimates none remained on market as of February 1995.
REASON Product exceeded tolerance for methomyl in asparagus.
_______________
PRODUCT Ice cream, yogurt, and frozen desserts:
(a) Multiple brand Mint Chocolate Chip Ice Cream, in half-
gallon retail units, and in 2.5 gallon and 3 gallon bulk
plastic and carton containers;
(b) Multiple brand Mint Chip Hard Pack Yogurt, in 2.5 and 3
gallon containers;
(c) Multiple brand Mint Chip Hard Pack No Sugar Added Frozen
Desert, in 2.5 and 3 gallon containers.
Recall #F-519/521-5.
CODE Code numbers ranging from 4010 to 4502.
MANUFACTURER Ice Cream Club, Inc. (The), Boynton Beach, Florida.
RECALLED BY Manufacturer, by letter December 5, 1994. Firm-initiated
recall complete.
DISTRIBUTION Georgia, Florida.
QUANTITY Firm estimates that there are no more than 36 half-gallon
units of Skinners' brand mint chocolate chip and 5 3-gallon
unit of Gladstone Farms brand mint chocolate chip in
commerce.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Preferred Christmas Treats, individual foil wrapped candy in
12 ounce plastic bags. Recall #F-524-5.
CODE Lot #1855.
MANUFACTURER R.M. Palmer Company, West Reading, Pennsylvania.
RECALLED BY Preferred Products, Inc., Chaska, Minnesota, by letter
December 22, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 425 cases (24 bags per case) were distributed.
REASON The candy contains undeclared peanuts.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Nature Food Centres "Tropical Snacks" packaged in 12 ounce
bags. Recall #F-502-5.
CODE Lot 0001 EXP 4/95.
MANUFACTURER Nature Food Centres, Wilmington, Massachusetts.
RECALLED BY General Nutrition, Inc., Pittsburgh, Pennsylvania, by letter
January 5, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Northeast and Midwest United States.
QUANTITY Firm estimated that 3,500 units remained on market at time
of recall initiation.
REASON Product contains undeclared sulfites.
-3- _______________
PRODUCT Cherry Nut Ice Cream packaged in 3 gallon cardboard bulk
containers. Recall #F-512-5.
CODE All bulk product manufactured in 1994 and in 1995 until
January 27, 1995.
MANUFACTURER Hagan Ice Cream Company, Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by delivering a product information notice on
February 1, 1995. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Maryland, West Virginia, Ohio, Kentucky,
Virginia.
QUANTITY Undetermined.
REASON Product contains undeclared peanuts.
_______________
PRODUCT Bottled Spring Water packaged in 11.8 ounce plastic bottles
in the following flavors: (a) Raspberry; (b) Strawberry;
(c) Peach/Orange; (d) Black Cherry. Recall #F-513/516-5.
CODE 09113, 10113, 11113, 12113, 13113, 07123, 07014, 08024,
09024, 10024.
MANUFACTURER Andres Wines, Winona, Ontario, Canada (bottling firm).
RECALLED BY Canadian Pure Beverage Distributors, West Palm Beach,
Florida, by telephone and by letters dated April 19, 1994
and December 23, 1994. Firm-initiated recall complete.
DISTRIBUTION Tennessee, North Carolina.
QUANTITY 7,838 cases (24 bottles per case) were distributed
REASON Product was contaminated with mold.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Liquid Oxygen for respiratory therapy, in size C, D, and E
cylinders. Recall #D-086-5.
CODE All lots.
MANUFACTURER Texas Air Supply Home Medical Equipment, Inc., Fort Worth,
Texas.
RECALLED BY Manufacturer, by visit November 10, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 500 cylinders were distributed; firm estimates none remains
on the market.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Medical Oxygen Cylinders, sizes A, B, D, E, H, & M.
Recall #D-087-5.
CODE Lot numbers: 951L417, 951L418, 951L423, 951L428, 951L429,
952L430, 950M405, 950M406, 950M409, 950M412, 951M416,
951M430.
MANUFACTURER Metrolina Welders Supply, Inc., (Welders Supply), Charlotte,
North Carolina.
RECALLED BY Manufacturer, by visit February 15, 1995. North Carolina
Department of Agriculture issued press release February 15,
1995. Firm-initiated recall complete.
-4- DISTRIBUTION North Carolina, South Carolina.
QUANTITY 12 lots were distributed.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Oxygen Compressed USP, compressed medical gas in cylinders.
Recall #D-088-5.
CODE Lot numbers: 257B522 EXP 2/22/96, 257B523 EXP 2/24/96,
258B527 EXP 2/27/95, 256B521 EXP 2/21/96, 256B520 EXP
2/20/96, 258B528 EXP 2/28/96.
MANUFACTURER Valley Welding Supply Company, Greensburg, Pennsylvania.
RECALLED BY Manufacturer, by telephone and by visit March 1, 1995,
followed by letter March 3, 1995. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania.
QUANTITY 131 units were distributed.
REASON Current good manufacturing practice deficiencies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Indocyanine Green USP, a prescription bulk pharmaceutical
chemical. Recall #D-085-5.
CODE Lot numbers: ACB57835, ACB57836, ACB57837, ACB57838.
MANUFACTURER Eastman Kodak Company, Rochester, New York.
RECALLED BY Manufacturer, by meeting October 18, 1993. Firm-initiated
recall complete.
DISTRIBUTION Maryland, New Mexico.
QUANTITY Approximately 7,000 grams were distributed.
REASON Subpotency.
_______________
PRODUCT Guaipax PSE Tablets (Pseudophedrine HCl 120 mg and
Guaifenesin 600 mg), sustained release, 100 tablets, Rx,
indicated for the relief of nasal congestion.
Recall #D-089-5.
CODE Lot #4C082 EXP 3/96.
MANUFACTURER Eon Laboratories Manufacturing, Inc., Laurelton, New York.
RECALLED BY Manufacturer, by letter March 7, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, California, Connecticut, Florida, Georgia, Hawaii,
Iowa, Illinois, Minnesota, Missouri, Mississippi, North
Carolina, Nebraska, New Jersey, New York, Oklahoma, Ohio,
Oregon, South Carolina, Texas, Puerto Rico.
QUANTITY 2,286 units of 100 tablets were distributed; firm estimates
very little of the product remains on the market.
REASON Product does not meet dissolution specifications for the
guaifenesin ingredient.
-5- _______________
PRODUCT Triple Sulfa Vaginal Cream, USP administered intravaginally,
used in the treatment of vaginal infection, in 2.75 ounce
(78 gram) metal tubes, under the following labels:
Rugby, Goldline, URL, Qualitest, Norega, Schein, H.L. Moore,
Hurst, Domel, Dayton, Econo Med, Best Generics, Reid-Rowell,
and IDE. Recall #D-090-5.
CODE Batch# EXP Batch# EXP Batch# EXP
O573 2/95 R403 11/95 S797 6/96
O581 2/95 R412 11/95 S805 6/96
O587 2/95 R419 11/95 T339 8/96
O598 2/95 R427 11/95 T347 8/96
0604 2/95 R433 11/95 T356 8/96
0840 3/95 R446 11/95 T363 8/96
O849 3/95 R455 11/95 T371 8/96
O857 3/95 R464 11/95 U025 10/96
O865 3/95 R616 12/95 U034 10/96
O873 3/95 R625 12/95 U042 10/96
P224 5/95 R634 12/95 U049 10/96
P232 5/95 R642 12/95 U057 10/96
P240 5/95 R650 12/95 V267 4/97
P248 5/95 R894 2/96 V275 4/97
P252 5/95 R903 2/96 V553 5/97
P522 6/95 R912 2/96 V564 5/97
P531 6/95 R922 2/96 V571 5/97
P539 6/95 S434 4/96 V805 6/97
P547 6/95 S442 4/96 V814 6/97
P554 6/95 S450 4/96 V824 6/97
P931 8/95 S460 4/96 V831 6/97
P947 8/95 S467 4/96 W613 10/97
P954 8/95 S776 5/96 W185 8/97
P959 8/95 S784 5/96 W137 8/97
W622 10/97 S790 5/96 W159 8/97
W169 8/97 W647 10/97 W662 10/97
W177 8/97 W654 10/97 V729 6/97
P939 8/95 V710 6/97.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter February 1, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, The Virgin Islands, West Indies, The Bahamas,
Bulgaria.
QUANTITY 698,338 tubes were distributed.
REASON Product does not meet pH specifications.
_______________
PRODUCT Nystatin/Triamcinolone Acetonide Cream USP, 120 g (4 ounce)
and 1 pound plastic jars, used for the treatment of topical
yeast infection, under the Clay Park and URL labels.
Recall #D-091-5.
CODE For 120g (4oz) jars: For 1lb. jars:
LOT# EXP. LOT# EXP.
O344 2/95 T427 10/96
-6- S216 5/96 T435 10/96
O658 3/95 P900 9/95
S667 7/95 S208 4/96
P900 9/95 P916 9/95
T806 11/95 S667 7/96
S200 4/96 S200 4/96.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter February 21, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 7,312 4-ounce jars and 901 1-pound jars were
distributed.
REASON Superpotency.
_______________
PRODUCT (a) Fluocinolone Acetonide Cream 0.025%, in 60g metal tubes,
used for the treatment of localized inflamed skin areas,
under the following labels: Clay Park, Goldline, Rugby,
Schein; (b) Fluocinolone Acetonide Cream 0.01% in 60 g
metal tubes, a corticosteroid used as an anti-inflammatory,
under the following labels: Clay Park, Goldline, Rugby
labels. Recall #D-092\093-5.
CODE Lot numbers: S129 EXP 3/95, S446 EXP 4/95, S455 EXP 4/95,
S924 EXP 6/95; (b) S122 EXP 3/95, S431 EXP 4/95, S437 EXP
4/95, S916 EXP 6/95, T213 EXP 7/95, T592 EXP 8/95.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter March 8, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION (a) Nationwide, St. Lucia; (b) Trinidad, St. Lucia.
QUANTITY (a) Approximately 11,666 tubes; (b) 21,800 tubes were
distributed.
REASON Potency not assured through expiration date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Red Blood Cells. Recall #B-197-5.
CODE Unit #7761666.
MANUFACTURER North Jersey Blood Center, East Orange, New Jersey.
RECALLED BY Manufacturer, by telephone July 26, 1994. Firm-initiated
recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product, which was exposed to unacceptable shipping
temperatures, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Baxter Pharmaseal Spinal and Saddle Block Anaesthesia Trays
containing 5 cc glass syringes (B-D Glaspak #5293) with
metal hub spinal needles, sterile, single use only:
-7- (a) Spinal Anesthesia Tray with Spinal Anesthetic and Spinal
Needle, 22 Ga, Catalog #4500C;
(b) Spinal Anesthesia Tray with Spinal Anesthetic and Spinal
Needle, 25 Ga, Catalog #4510C;
(c) Spinal Anesthesia Tray with Spinal Anesthetic,
Epinephrine,and Spinal Needle 25 Ga, Catalog #4511C;
(d) Saddle Block Anesthesia Tray with Spinal Anesthetic,
Ephedrine Sulfate, and Spinal Needle, 25 Ga, Catalog #4518C;
(e) Custom Spinal Anesthesia Tray with Spinal Anesthetic,
and Spinal Needle, 22 Ga, Catalog #514504072;
(f) Custom Anesthesia Tray with Spinal Anesthetic and Spinal
Needle, 25 Ga, Catalog #6845141200. Recall #Z-397/402-5.
CODE Lot numbers: (a) K4C378; (b) K4C377 and K4C377A;
(c) K4C375; (d) K4C376A and K4C376B; (e) K4C191E;
(f) K4C198E.
MANUFACTURER Becton-Dickinson, Franklin Lakes, New Jersey (Syringe).
RECALLED BY: Baxter Healthcare Corporation, Round Lake, Illinois, by
letter October 3, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and International.
QUANTITY 16,493 trays were distributed; firm estimated that 30% of
the product remained on market at time of recall initiation.
REASON There is a potential for leaking to occur at the connection
between the 5cc glass syringe (B-D Glaspak #5293) and the
metal hub spinal needles.
_______________
PRODUCT Glutaraldehyde Disinfectant/Sterilization Solution, in 1
gallon containers:
(a) Baxter Omnicide 14 N.S., Catalog #25182-214;
(b) VHA + Plus SDS 14 N.S., Catalog #V-2250.
Recall #Z-438/439-5.
CODE Lot numbers: (a) 2107; (b) 2196.
MANUFACTURER Cottrell, Ltd., Englewood, Colorado.
RECALLED BY Manufacturer, by verbal notification August 16, 1994,
followed by letter August 17, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Illinois, Pennsylvania, Virginia, Nebraska, Indiana.
QUANTITY 5,876 gallons were distributed; firm estimated that 5,200
remained on market at time of recall initiation.
REASON A quantity of glutaraldehyde product containing a surfactant
was inadvertently pumped into the mixing tank dedicated to
the production of the subject products, which are non-
surfactant glutaraldehyde products.
_______________
PRODUCT Sechrist Model 2200B Ventilator, indicated for the delivery
of medical grade air and oxygen to adult/pediatric patients.
Recall #Z-454-5.
CODE Serial number sequences 90Y8386 through 90Y9269 and 91501
through 91918.
MANUFACTURER Sechrist Industries, Inc., Anaheim, California.
RECALLED BY Manufacturer, by letter March 1, 1994. Firm-initiated
recall ongoing.
-8- DISTRIBUTION Nationwide and international.
QUANTITY 357 units were distributed.
REASON Due to a defective voltage monitor, the product may cease
ventilation without audible and visual alarms.
_______________
PRODUCT Sechrist Ventilator, Model 2200B, a microprocessor
controlled ventilator, indicated for the delivery of medical
grade air and oxygen to adult/pediatric patients.
Recall #Z-496-5.
CODE Serial Numbers 91792, 91794, 91795, 91797, 91799, 91800,
91803, 91804-91806, 91809-91823, 91825-91830, 91833, 91835,
91837-91843, 91847, 91849-91857, 91861, 91863-91871,
91877-91887, 91889, 91891, 91892, 91896-91899, and 91901.
MANUFACTURER Sechrist Industries, Inc., Anaheim, California.
RECALLED BY Manufacturer, by letter February 23, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Idaho and International.
QUANTITY 79 units were distributed.
REASON Leakage caused by a defective refill valve results in an
inaccurate delivery of gas volume and pressure.
_______________
PRODUCT Respironics brand BIPAP 30 Ventilatory Support Systems, a
non-continuous ventilator for non-life support applications:
(a) Model 552006 BiPAP S/T-D30;
(b) Model 552045 BiPAP S/T-D30;
(c) Model 552049 BiPAP S/T-D30;
(d) Model 552052 BiPAP S/T-D30. Recall #Z-498/501-5.
CODE Serial numbers from 10000 through 10296.
MANUFACTURER Respironics, Inc., Murrysville, Pennsylvania.
RECALLED BY Manufacturer, by telephone January 9, 1995, followed by
letter January 11, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Taiwan, Spain, Netherlands, Kowloon, France,
Canada, The United Kingdom.
QUANTITY 189 units were distributed.
REASON Under certain conditions, the interaction between the
spontaneous/times mode and the breaths per minute control of
the affected BiPAP S/T-D30 and S/T 30 devices results in the
devices operating outside the product specifications. The
result is that there is the potential for the delivered
breaths per minute to be lower than the desired rate.
_______________
PRODUCT High Frequency Oscillatory Neonatal Ventilator, Model 3100A,
indicated for ventilatory support and treatment of
respiratory failure and barotrauma in neonates.
Recall #Z-497-5.
CODE Serial numbers 31204 through 31848, excluding 31359 through
31378.
MANUFACTURER Sensormedics Corporation, Yorba Linda, California.
RECALLED BY Manufacturer, by letter dated November 22, 1994. Firm-
initiated recall ongoing.
-9- DISTRIBUTION Nationwide, Australia, Canada, Hong Kong, Korea, Mexico,
Netherlands, Philippines, Singapore, Taiwan.
QUANTITY 625 units were distributed.
REASON A wire next to the metal amplifier bracket may abrade, due
to vibration, causing a potential electrical shock hazard.
_______________
PRODUCT Sharpe ENDO Assist Endoscopic Knot Pusher, Product #87000,
product size 10 mm, a reusable laparoscopic device used for
the extracorporeal tying of suture knots. Recall #Z-510-5.
CODE All lots.
MANUFACTURER Sharpe Endosurgical Corporation, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter February 6, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, England, France, Ireland, Japan.
QUANTITY 62 units were distributed.
REASON Plastic pieces of the sheath (plastic tube), that covers the
laparoscopic mechanism of the device, have broken off the
distal end of the tube which enters the patient's body,
potentially allowing pieces to fall into a patient's body
cavity.
_______________
PRODUCT All Intervascular Inc., non radially-supporting, Dacron
Axillo-Femoral Protheses, including all types (woven or
knitted), diameters: (a) Ochner 200;
(b) Ochner 500; (c) Micron; (d) Medium Porosity;
(e) Low Porosity. Recall #Z-511/515-5.
CODE All serial numbers. All catalog numbers.
MANUFACTURER Intervascular, Inc., Clearwater, Florida.
RECALLED BY Manufacturer, by letter July 1994. Firm-initiated recall
complete.
DISTRIBUTION California, Illinois, Pennsylvania, Louisiana, Tennessee,
Mississippi, Florida, and international.
QUANTITY 48 units.
REASON The manufacturer is marketing the device without an approved
premarket notification submission (510k).
_______________
PRODUCT Adult Expandable Breathing Circuits and All Products,
Including Various Anesthesia Kits As Components.
Recall #Z-521/533-5.
CODE Catalog No. Lot No.
VIXYGNGZ 026L
5930HIJO 011J/011K/013J/013L
/024L/004K
5935 019K/025J
5935CET 351S
5935E 351S
5950 007K/013J/020K
5950M8 351F
5955TW 004K
-10- 6GY90MYX 012J/017J
6QAFNUX 355F
6QAFYNVX 355F
6Q555NPX 356S/375T/362F/362S/024L
7U400NXB 362F.
MANUFACTURER Vital Signs, Totowa, New Jersey.
RECALLED BY Manufacturer, by letter February 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Alabama, California, Georgia, Illinois, Kansas, Kentucky,
North Carolina, Nebraska, New York, Texas, Washington State,
Wyoming.
QUANTITY 2,225 units were distributed.
REASON Exposure to extremely cold temperatures may cause the
expandable tubing to crack when flexed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Beckman Synchron CX7 Clinical Analyzer, computer enhanced,
CX4CE/CX5CE), indicated for in-vitro chemistry testing.
Recall #Z-520-5.
CODE All units with Software Version 2.1; part number 468120;
Version 1.8/2.2, part #469260; Version 2.2, part #469285.
MANUFACTURER Beckman Instruments, Inc., Brea, California.
RECALLED BY Manufacturer, by letter dated July 14, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,553 units were distributed.
REASON Defective software may cause patient samples to be
incorrectly sampled, which may cause incorrect patient
results to be reported.
_______________
PRODUCT Stratus Prolactin Fluorometric Enzyme Immunoassay Kit with
"Code 35" values. Recall #Z-534-5.
CODE Calibrator lots XPL1-121 through XPL6-621 which are
contained in kit lot #KXPL-195M which expires 2/28/95.
MANUFACTURER Baxter Diagnostics, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter on or about September 24, 1994.
Firm-initiated field correction complete.
DISTRIBUTION Texas, West Virginia, South Carolina, Pennsylvania, Ohio,
Nebraska, Iowa, Kansas, Colorado, Arizona, Arkansas.
QUANTITY 12 kits were distributed.
REASON The technical bulletin which is enclosed with this kit has
incorrect "Code 35 values" for the Stratus II users which
causes the assay to be unusable.
_______________
PRODUCT Dade CK-MB/Myoglobin Immunoassay Control, Level 1, Level 2,
and Level 3: (a) Catalog #B5200/B5200-S (sample);
(b) Catalog #B5200-1; (c) Catalog #B5200-2; (d) Catalog
#B5200-3. Recall #Z-535/538-5.
-11- CODE Lot numbers: (a) MBCK-19M; (b) MBC1-109M; (c) MBC2-209M;
(d) MBC3-309M.
MANUFACTURER Baxter Diagnostics, Inc., also known as Dade International,
Miami, Florida.
RECALLED BY Manufacturer, by letter sent on or about January 24, 1995.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 3,888 kits were distributed.
REASON The myoglobin reconstituted stability on level III maintains
for only three days after reconstitution. The product
insert states that the reconstituted product is stable for
14 days when stored at 2 to 8 degrees Centigrade.
_______________
PRODUCT Medilog Ambulatory Blood Pressure Monitor (ABP), Rx medical
device used to measure blood pressure and heart rate over
extended periods of time (up to 72 hours). Recall #Z-539-5.
CODE Serial numbers: BP0922, BP11407, BP11318, BP11325.
MANUFACTURER Oxford Instruments, Ltd., Medical Systems Division, Abingdon
Oxon, England.
RECALLED BY Oxford Instruments Medical Systems, Division, Clearwater,
Florida, by letter dated November 10, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Canada, Argentina.
QUANTITY 4 units were distributed.
REASON A faulty capacitor in the device is susceptible to becoming
resistive, resulting in inaccurate blood pressure
measurements.
MEDICAL DEVICE SAFETY ALERT
===============================================
_______________
PRODUCT LuSee TLC Steerable Guidewires, designed to provide maximum
torque control and steerability enabling the guidewire to
transverse tortuous vessels and tight stenoses:
(a) LuSee PLC Steerable Guidewire, soft, super soft,
standard tip flexibilities; (b) 0.009"/0.014" Microlucent
Guidewire; (c) 7 cm Radiolucent Stabilizer Extra Support
Guidewire. Safety Alert #N-023/025-5.
CODE All codes/serial numbers.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
ALERTED BY Manufacturer, by letter January 12, 1995.
DISTRIBUTION Nationwide and international.
REASON Tip fractures have been reported in procedures involving
total occlusions, highly tortuous vasculature and
interferring small side branches.
SEIZURE:
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PRODUCT Frozen Scallops (95-745-218 et al).
-12- CHARGE Adulterated - The articles consist in whole or in part of a
decomposed substance by reason of the presence therein of
decomposed scallops.
LOCATION Gulf Atlantic Cold Storage, Inc., Gretna, Louisiana.
FILED February 21, 1995; U.S. District Court for the Eastern
District of Louisiana; Civ. #95-0604; FDC #67065.
SEIZED March 3, 1995 - goods valued at approximately $44,000.
MASS SEIZURE:
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PRODUCT Bulk spices, rice, flour products, and various other
articles of food (95-741-369).
CHARGE Adulterated - The articles have been held under insanitary
conditions whereby they may have become contaminated with
filth.
LOCATION: U.S. Spice, Chicago Heights, Illinois.
FILED January 24, 1995; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civ. #95C 0452;
FDC #67057
SEIZED March 3, 1995 - goods valued at approximately $12,000.
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END OF ENFORCEMENT REPORT FOR MARCH 22, 1995. BLANK PAGES MAY
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