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
02/15/1995

Recalls and Field Corrections: Foods -- Class I -- 02/15/1995

February 15, 1995 95-7

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Petit Fours, doboshettes, brownies and any gift pack
containing any of these products, under one or more of the
following labels: Swiss Colony, Green County, Figi's,
Clasen Candy, Hickory Farms, Marshall Fields, Wisconsin,
Cheesemen, and Neiman-Marcus:
1. Raspberry Truffle PF
2. Suisse Mint Desert Cakes
3. Reception Cakes
4. Chocolate Truffle PF
5. Liqueur PF
6. Special Edition PF
7. Pastel PF
8. Assorted PF
9. Choc. Delight PF
10. Holiday Greetings/decorated
11. Traditional PF
12. Choc. Mint PF
13. Harvest PF
14. Reception PF
15. German Choc. PF
16. Red Velvet PF
17. Double Chocolate PF
18. Strawberry Cheesecake PF
19. Carrot Cake PF
20. Rose Bud Reception PF
21. Easter Decorated PF
22. Choc Brownies w/oreos
23. Choc. Brownies w/Heath Bits
24. Double Choc. Brownies
25. Choc. Brownies w/Snickers
26. Fudge Walnut Brownies
27. Toffee Crunch, Double Choc.
28. Caramel & Peanut, Cookies 'N Creme, & Candy Crunch
29. Li'L PF
30. Chocolate Lovers PF
31. Choc. Raspberry PF
32. Black & White PF
33. Lemon Diamond PF
34. Red Heart PF
35. Chocolate PF
36. Xmas Festival Cakes
37. Holiday Reception PF
38. Lemon PF
39. Choc./Assorted Clamshell
40. Valentine PF
41. Happy Holiday Truffle PF
42. Holiday PF
43. Doboshettes
44. Gourmet Brownies
45. Harvest Doboshettes
46. Triple Choc. Brownies
47. Merry Christmas PF
48. Royal Chocolate PF
49. Christmas PF
50. PF for a Special Grandma
51. Truffle Bon Bons
52. Chocolate Doboshettes
53. Mint Torte
54. 18 Favorites
55. Snack Sensation
56. Merry Christmas Collection
57. Santa's Christmas Bag
58. Christmas Collection w/11 Favorites
59. Christmas Collection w/51 Favorites
60. Christmas Collection w/65 Favorites
61. Christmas Wishes
62. Yuletide Fare
63. Old ST. Nick Bag
64. 43 Holiday Favorites
65. Chocoholic's Survival Kit
66. Christmas Towers
67. Floral Towers
68. Sparkling Star Towers
69. Toy Store Tins
70. Christmas Collections
71. Merry Christmas Sampler
72. Luxury Assortment. Recall #F-335/406-5.
-2-CODE All products manufactured between January 1 and October 19,
1994. These products bear codes 8701 through 9592.
MANUFACTURER The Swiss Colony, Monroe, Wisconsin.
RECALLED BY Manufacturer, by letter dated October 23, 1994, and by press
release October 24, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 85,000 cases. Cases can range in varying
quantities from 4 to 612 pieces.
REASON The petit fours, doboshettes, and brownies, which are in the
various gift packs, are or may be contaminated with Listeria
monocytogenes.

_______________
PRODUCT Petit Fours, doboshettes, brownies, and any gift pack
containing any of these products:
1. Tastefully Yours; 2. Taste Delights
3. Treasurer Chest; 4. Showcase Collection
5. Variety Tower; 6. Holiday Tower
7. Festive Tower; 8. Winter Time Warmer
9. Premier Gift; 10. Noel Basket
11. Grand Turkey Feast 12. Holiday Centerpiece
13. Bakery Tower 14. Taste Tempter.
Recall #F-409/422-5.
CODE Gift packs containing the suspect Petit Fours are identified
with code dates of 200 through 299. These codes may be
preceded or followed by a letter (Aor B), or a number (1 or
2). There is also a minimum of one space between the code
date and the single letter or number.
MANUFACTURER Swiss Colony, Monroe, Wisconsin.
RECALLED BY Hickory Farms, Inc., Maumee, Ohio, by E-Mail message sent
October 28, 1994, followed by letter October 31, 1994 to
stores; by telephone and letter dated November 1, 1994 to
catalog customers; and by telephone October 28, 1994,
followed by letter dated October 31, 1994 to cold-storage
warehouses. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Mexico.
QUANTITY 560 component packages were distributed.
REASON The petit fours, doboshettes, and brownies, which are in the
various gift packs, are or may be contaminated with Listeria
monocytogenes.

_______________
PRODUCT The following gift packs, packed and distributed by The
Wisconsin Cheeseman, Sun Prairie, WI, contain Petits Fours
and Tortes manufactured by Swiss Colony, Monroe, WI. The
gift packs are labeled as distributed by The Wisconsin
Cheeseman, Sun Prairie, WI:
1.75 Oz. Box of Petits Fours went into the following gift
packs:
Gift #10 - Good Cheer Pak
Gift #158 - Centerpiece
Gift #709 - Smorgasbord (3.5 oz. Chocolate Creme Tortes
were also packed into the Smorgasbord)
-3- 2 Oz. Box of Grace Rush Petits Fours went into the following
gift packs:
Gift #84 - Smoked Turkey Assortment
Gift #108 - Merry Christmas
Gift #131 - Party Parade
Gift #151 - Stocking Stuffers
Gift #500 - Free Gift - Customer
Gift #528 - Holiday Bonanza
Gift #573 - Party Maker
Gift #734 - Family Feast
Gift #768 - Happy Holidays
Gift #941 - Grand Assortment
4.5 Oz. Box of Petits Fours went into the following gift
packs:
Gift #85 - The International
Gift #102 - Ten High Tower
Gift #759 - The Ultimate w/o Turkey
Gift #918 - The Ultimate
3.5 Oz. Chocolate Creme Tortes went into the following gift
packs:
Gift #88 - Happy Eating
Gift #597 - Dessert Tower
Gift #609 - Christmas Tower
Gift #709 - Smorgasbord (1.75 Oz. Box of Petits Fours
were also packed into the Smorgasbord)
14.25 Oz. Box of Petits Fours went into the following gift
packs:
Gift #90 - Petits Fours
Gift #199 - Petits Fours
Gift #89 - Tray and Petits Fours
17.7 Oz. Box of Petits Fours went into the following gift
packs: Gift #67 - Petits Fours; Gift #571 - Petits Fours
8.75 Oz. Box of Petits Fours went into the following gift
packs: Gift #634 - Petits Fours; Gift #38 - Treasure Tower
8.5 Oz. Box of Petits Fours went into the following gift
packs: Gift #655 - Sweet Circles; Gift #110 - Showcase;
7 Oz. Box of Petits Fours went into the following gift pack:
Gift #431 - Petits Fours;
3.5 Oz. Box of Petits Fours went into the following gift
pack: Gift #737 - Carrousel;
16 Oz. Box of Petits Fours went into the following gift
pack: Gift #55 - Royal Chocolate Eclairs;
Petits Fours and Tortes, made by Swiss Colony, were packed
into gift packs distributed by Mille Lacs M.P. Company, Sun
Prairie, WI (wholly owned subsidiary/wholesale division of
The Wisconsin Cheeseman) under the Mille Lacs and Grace Rush
private labels:
2 Oz. Box of Petits Fours went into the following gift pack:
Gift #4560 - Flavor Favorites
3.5 Oz. Box of Chocolate Creme Tortes went into the
following gift pack: Gift #4510 - Dessert Tower

-4- 7.1 Oz. Box of Grace Rush Assorted Petits Fours went into
the following gift packs:
Gift #4107 - Elegant Sweets
Gift #43165 - Assorted Petits Fours
Gift #43169 - Assorted Petits Fours
Gift #7867 - Assorted Petits Fours
16 Oz. Box of Grace Rush Assorted Petits Fours went into the
following gift packs:
Gift #43164 - Assorted Petits Fours
Gift #43186 - Assorted Petits Fours. Recall #F-423/463-5.
CODE None. The gift boxes were distributed from July 21, 1994 to
October 28, 1994.
MANUFACTURER The Swiss Colony, Monroe, Wisconsin.
RECALLED BY Wisconsin Cheeseman, Inc.; Mille Lacs M.P. Company, Sun
Prairie, Wisconsin, by letter dated November 14 and 15,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY The following amounts of the products were packed into gift
packs distributed by The Wisconsin Cheeseman: 92/1.75 ounce
boxes of petits fours; 191/2 ounce boxes of petits fours;
46/4.25 ounce boxes of petits fours; 43/3.5 ounce chocolate
creme tortes; 134/14.25 ounce petits fours; 195/17.7 ounce
boxes of petits fours; 127/8.75 ounce boxes of petits fours;
28/8.5 ounce boxes of petits fours; 164/7 ounce boxes of
petits fours; 50/3.5 ounce boxes of petits fours; and 34/16
ounce boxes of petits fours.
The following amounts of the products were packed into gift
packs distributed by Mille Lacs M.P. Company: 9/2 ounce
boxes of petits fours; 110 cases, each case containing 27
boxes, each box containing 16 petits fours (7.1 ounce/box);
87 cases, each case containing 12 boxes, each box containing
36 petits fours (16 ounce/box); and 6/3.5 ounce chocolate
creme tortes.
REASON Petit fours, doboshettes, and brownies, which are in the
various gift packs, are or may be contaminated with Listeria
monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Planters Peanut Butter Chocolates, in 6 ounce stand up bags.
Recall #F-333-5.
CODE Lot numbers 51491 and 51492.
MANUFACTURER Beacon Sweets, Inc., Morresville, North Carolina.
RECALLED BY Planters Lifesaver, Inc., Winston-Salem, North Carolina, by
telephone September 2, 1994. Firm-initiated recall
complete.
DISTRIBUTION North Carolina, Illinois, Iowa, Minnesota, Ohio, Tennessee,
Texas, Wisconsin.
QUANTITY 2,091 cases (12 bags per case) were distributed; firm
estimates none remains on the market.
REASON Product was contaminated with Salmonella.

-5-_______________
PRODUCT Critic's Choice Cereal Sugar Coated Corn Flakes, in 40 ounce
boxes. Recall #F-408-5.
CODE Lot code 3287D553 found on the top flap of box.
MANUFACTURER Organic Milling Company, San Dimas, California.
RECALLED BY Amway Corporation, Ada, Michigan, by letter February 2,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 72 cases (6 boxes per case) were distributed.
REASON Product was contaminated with glass.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Peanuts in 1-3/4 ounce cans, labeled in part "Harry and
David Honey Roast Nuts." Recall #F-334-5.
CODE R71.
MANUFACTURER Harry and David Corporation owned by Bear Creek Corporation,
Medford, Oregon.
RECALLED BY Manufacturer, by letter December 22, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 48,000 cans.
REASON Product was mislabeled. Peanuts were labeled as cashews.

_______________
PRODUCT Promise Extra Light Margarine Quarters, in 1 pound boxes.
Recall #F-407-5.
CODE The following "Best When Purchased By" dates include the
lots of the recalled product: April 24th, May 1st, May 8th,
May 15th, May 22nd, May 29th, June 5th, and June 12th, 1993.
MANUFACTURER Van Den Bergh Foods Company, Baltimore, Maryland.
RECALLED BY Van Den Bergh Foods Company, Division of Unilever United
States, Inc., New York, New York, by letter December 31,
1992. Firm-initiated recall complete.
DISTRIBUTION Undetermined.
QUANTITY Firm estimates none remains on the market.
REASON Product was contaminated with mold.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT (a) Lortab-5, 15 tablets, Hydrocodone Bitartrate 5 mg and
Acetaminophen, 500 mg; (b) Propoxyphene with APAP, 15
tablets, Propoxyphene Napsylate 100 mg, Acetaminophen 650
mg, Rx analgesic. Recall #D-059/060-5.
CODE Lot numbers: (a) 12159401 EXP 6/15/95; (b) 12159402 EXP
6/15/95.
MANUFACTURER Sentara Pharmacy Services, Virginia Beach, Virginia
(Repacker).
RECALLED BY Repacker, by visit January 4-5, 1995, and by fax sent
January 11, 1995. Firm-initiated recall ongoing.

-6-DISTRIBUTION Virginia.
QUANTITY 36 bottles were distributed.
REASON A bottle containing Lortab-5 Tablets was mislabeled as
Propoxyphene/Acetaminophen Tablets.

_______________
PRODUCT Zestoretic Tablets (Lisinopril/Hydrochlorothiazide), 20/12.5
mg and 20/25 mg, an angiotensin converting enzyme inhibitor
(Lisinopril) and diuretic (Hydrochlorothiazide) combination
indicated for the treatment of hypertension.
Recall #D-062/063-5.
CODE 20/12.5 mg tablets; 100 tablet bottles
Lot EXP Label Codes
3123P 7/95 64031-05 (PIB)
3124P 7/95 60124-01 (LABEL)
3125P 12/95 69087-02 (SHIPPER)
3311P 12/95
3657P 12/95
4104P 7/95
20/12.5 mg tablets; blisters
3076P 12/95 64031-04 (PIB OBSOLETE)
34726-00 (RTE BOX OBSOLETE)
39046-01 (FOIL OBSOLETE)
33232-00 (SHIPPER)
3625P 7/95 64031-05 (PIB)
4087P 8/95 34726-01 (RTE BOX OBSOLETE)
38220-00 (FOIL)
33242-00 (SHIPPER)
20/25 mg tablets; 100 tablet bottles
3165P 7/96 64031-05 (PIB)
3166P 11/95 60125-01 (LABEL)
3167P 11/95 69088-02 (SHIPPER)
3373P 7/96
20/25 mg tablets; blister
3642P 7/96 64031-05 (PIB)
34728-01 (RTE BOX OBSOLETE)
39052-00 (FOIL)
33243-00 (SHIPPER)
MANUFACTURER Zeneca Pharmaceuticals, Newark, Delaware.
RECALLED BY Zeneca Pharmaceuticals, Wilmington, Delaware, by telephone
December 9, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,272 cases (96 blisters per case) and 8,826 cases (12
bottles were distributed; firm estimates that no more than 5
percent of amount distributed remained on market at time of
recall initiation.
REASON Lack of assurance that the products will meet dissolution
specifications for the hydrochlorothiazide ingredient.

-7-_______________
PRODUCT Isordil Tembids (Isosorbide Dinitrate) 4 mg extended release
tablets in 100 tablet bottles, a vasodilator and is
indicated for the treatment and prevention of angina
pectoris. Recall #D-064-5.
CODE Lot #9933069 EXP 8/95, bulk lot P930100.
MANUFACTURER Wyeth-Ayerst Laboratories, Inc., Frazer, Pennsylvania.
RECALLED BY Wyeth-Ayerst Laboratories, Inc., St. Davids, Pennsylvania,
by letter December 30, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 27,972 bottles were distributed.
REASON Use of an unapproved grade of aluminum stearate.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Estratab (Esterified Estrogens Tablets, USP), 1.25 mg, in
bottles of 100 and 1000. Recall #D-061-5.
CODE Lot #84636.
MANUFACTURER Solvay Pharmaceuticals, Baudette, Minnesota.
RECALLED BY Solvay Pharmaceuticals, Marietta, Georgia, by letter
November 18, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 12,160 100-tablet bottles and 735 1000-tablet bottles were
distributed.
REASON Product below potency specification prior to expiration
date.

_______________
PRODUCT Doctor's Best brand Dry Skin Creme, in 2 ounce and 4 ounce
plastic jars, containing 20 percent urea cream designed for
treatment and relief of eczematous dry skin, OTC for topical
use. Recall #D-065-5.
CODE All lots.
MANUFACTURER Vita Erb Limited, Springfield, Missouri.
RECALLED BY Sherwood Pharmaceutical, Inc., Springfield, Missouri, by
letter January 24, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Missouri, Illinois, Arkansas, Mississippi, Florida,
Michigan, Kansas, Alabama, Kentucky, Texas, Tennessee.
QUANTITY 300 4-ounce jars and 1,678 2-ounce jars were distributed.
REASON Presence of mold.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Lifeline Blood Bank Management System Software.
Recall #B-158-5.
CODE Releases 4.0 and 4.0b.
MANUFACTURER Informedics, Inc., doing business as Western Star, Lake
Oswego, Oregon.
RECALLED BY Manufacturer, by issuing Program Update Reports and
Technical Action Reports. Firm-initiated field correction
ongoing.
-8-DISTRIBUTION Nationwide and international.
QUANTITY Approximately 200 copies of the various releases have been
distributed.
REASON Computer software, that contained programming errors which
could result in the release of unsuitable blood products,
was distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Lifeline Blood Bank Management System Software.
Recall #B-159-5.
CODE Releases 4.0a and 4.0c.
MANUFACTURER Informedics, Inc., doing business as Western Star, Lake
Oswego, Oregon.
RECALLED BY Manufacturer, by issuing Program Update Reports and
Technical Action Reports. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 200 copies of the various releases have been
distributed.
REASON Computer software, that contained programming errors which
could result in deficiencies in record keeping required by
good manufacturing practice regulations, was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Clinac Medical Linear Accelerators:
(a) Model 2100 C/D; (b) Model 2300 C/D;
(c) Model 600 C. Recall #Z-255/257-5.
CODE Serial numbers: (a) 28, 212, 242, 250, 294, 306, 317, 320,
321, 330-334, 339-347, 351, 354, 356, 359-382, 384-396, 398,
400, 401; (b) 1, 2, 4; (c) 13, 23, 91, 92, 97-132.
MANUFACTURER Varian Associates, Inc., Oncology Systems, Palo Alto,
California.
RECALLED BY Manufacturer, by sending a "Dear Clinac User" letter
February 18, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 113 units.
REASON A software problem causes the systems to not properly
identify an incorrect accessory in position. This results
in a failure to activate safety interlocks that prevent an
unwanted "beam-on" condition, which could further result in
an incorrect radiation dose being applied to the patient.

_______________
PRODUCT Sterile ophthalmic solutions for use with contact lenses,
extension of Recall #Z-931/934-4 which appeared in the June
29, 1994 Enforcement Report:
(a) Sherman Stay-Wet 4 - Wetting, lubricating, rewetting
drops for fluoro/silicone acrylate and silicone acrylate
(RGP) contact lenses, 30/30 ml;
-9- (b) Sherman de-Stat 4 - Cleaning, disinfecting and storage
solution for fluoro/silicone and silicone acrylate (RGP)
contact lenses, 118/120 ml;
(c) Sherman Sof/Pro Clean (Thimerosal), daily cleaner for
soft (hydrophilic) contact lenses, 30 ml.
Recall #Z-323/325-5.
CODE Lot numbers: (a) 0814; (b) 0634; (c) 0114, 2692.
MANUFACTURER Sherman Pharmaceuticals, Abita Springs, Louisiana.
RECALLED BY Sherman Pharmaceuticals, Mandeville, Louisiana by letters on
or about July 6, 1994, and November 10, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 6,587 units of de-Stat 4; 7,088 units of Stay
Wet 4, and 8,936 units of Sof/Pro Clean (Thimerosal) were
distributed.
REASON Sterility may have been compromised due to potential
inadequate sterilization.

_______________
PRODUCT Children's Sunglasses (included in beachbag and tote bag
sets):
(a) Style #3342, sunglasses included in Barney logo bag
with plastic strap and snap closing or cord strap
and gathered closing;
(b) Style #3343, sunglasses included in case attached
to Barney logo bag with plastic strap and snap closing;
(c) Style #3370, sunglasses included in case attached to
Barney logo bag with plastic strap and velcro closing;
(d) Style #3312, sunglasses in plastic pouch which is
either attached directly to bag or in plastic pouch
attached with plastic strap, bag has beach scene
with cats, with words along the edge of the bag,
with a plastic strap with velcro closing;
(e) Style #3315, sunglasses in plastic pouch which is
either attached directly to bag or in plastic pouch
attached with plastic strap, bag has a beach scene
with people, no wording, snap closing;
(f) Style #3371, sunglasses in plastic pouch which is
either attached directly to bag or in plastic pouch
attached with plastic strap, bag has beach scene
with cats, with words along the edge of the bag,
with a plastic strap with velcro closing, smaller
version of style #3312. Recall #Z-376/381-5.
CODE None.
MANUFACTURER Hoi Tak Handbag Factory, Kowloon, Hong Kong.
RECALLED BY Jaclyln, Inc., West New York, New Jersey, by mailing letters
beginning on or about March 11, 1993, and by press release
issued March 26, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 210,624 beach bags containing sunglasses were
distributed.
REASON The sunglasses may fail to meet FDA's requirements for
impact resistant lenses.
-10-_______________
PRODUCT Hanks' Balanced Salt Solution, for in-vitro diagnostic use.
Recall #Z-382-5.
CODE Catalog #14025-027, Lot #13P2147 EXP 7/30/97.
MANUFACTURER Life Technologies, Inc., Grand Island, New York.
RECALLED BY Manufacturer, by letter January 12, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Taiwan, Japan, Hong Kong.
QUANTITY 1,660 units were distributed.
REASON Sterility of the device is compromised due to bacterial
contamination with gram negative rods.

_______________
PRODUCT Millar Model TC-510 Control Unit, a control unit which is an
interface between the catheter pressure transducer and the
strain gauge amplifiers. It's intended to aide in measuring
blood pressure. Recall #Z-386-5.
CODE Serial numbers: 3186, 3188, 3192, 3193, 3195, 3196, 3198,
3204, 3210.
MANUFACTURER Concord Technologies, Houston, Texas.
RECALLED BY Millar Instruments, Inc., Houston, Texas, July 25, 1994.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 9 units were distributed and recovered from the market.
REASON Unauthorized modifications were made by the contract
manufacturer which resulted in the potential for inaccurate,
erratic, or no blood pressure readings.

_______________
PRODUCT CV Catheter with Groshong Valve Long Term Single Lumen, 8
French (Product #7711800) and CV Catheter 5 French with
Groshong Valves, Long Term Dual Lumen Percutaneous Placement
Procedure Tray. Product is an extension of Recall #Z-346-4
which appeared in the March 16, 1994, designed for long term
access to the vascular system for the delivery of
medications, intravenous fluids, parenteral nutrition
solutions, blood products and imaging solutions, and for the
withdrawal of blood samples. Recall #Z-387/390-5.
CODE Product Code Lot Number
(a) 7711800 36KD6058
(b) 7726500 36KD6792
(c) 7724157 36LD6343
(d) 7726954 36LD6137.
MANUFACTURER Bard Access Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone November 22-23, 1993, and by
letter November 24, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) Approximately 500 units; (b) 31 units; (c) 10 units; (d)
2 units were distributed.
REASON The guidewires exhibited a greater than acceptable level of
pyrogens.

-11-_______________
PRODUCT Medtronic Capsure SP Model 5524M-53CM Steroid Eluting
Bipolar, Implantable Tined, Atrial, Transvenous Leads.
Recall #Z-396-5.
CODE Serial numbers: LAV021683V, LAV021686V, LAV021687V,
LAV021688V, LAV021690V, LAV021693V, LAV021694V, LAV021695V,
LAV021696V, LAV021698V, LAV021705V, LAV021706V, LAV021707V,
LAV021708V, LAV021709V, LAV021711V, LAV021712V.
MANUFACTURER Medtronic Puerto Rico, Inc., Villalba, Puerto Rico.
RECALLED BY Medtronic, Inc., Minneapolis, Minnesota, by telephone
December 21, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 18 leads were distributed.
REASON The connector sleeve at the proximal end of the leads are
labeled "VEN" instead of "ATR".

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Scalpex Reusable Ophthalmic & Microsurgical Scalpels, used
in surgical procedures, primarily ophthalmic, for cutting
tissues:
(a) Model #9036, Angled, Bevel Down, Slit, 2.5 mm;
(b) Model #9102, Angled, Bevel Down, Circular, 2.25 mm;
(c) Model #9041, Angled, Bevel Up, Slit, 2.65 mm;
(d) Model #9053, Angled, Bevel Up, Slit, 3.0 mm;
(e) Model #9059, Angled, Bevel Up, Slit, 3.2 mm;
(f) Model #9116, Angled, Bevel Up, Crescent, 1.4 mm;
(g) Model #9121, Angled, Blunt Tip, 4.8 mm;
(h) Model #9123, Angled, Blunt Tip, 5.2 mm;
(i) Model #9122, Straight, Blunt Tip, 5.2 mm;
(j) Model #9034, Straight Blade, Slit, 5.2 mm.
Recall #Z-366/375-5.
CODE Lot numbers: (a) 23159, 23754; (b) 23755;
(c) 23256; (d) 23484, 23700; (e) 23582, 23608, 23609, 23610;
(f) 23304, 23611, 23635, 23738; (g) 23430, 23438, 23634;
(h) 23439; (i) 23485; (j) 23507.
MANUFACTURER D.S. Manufacturing, Inc., Ventura, California.
RECALLED BY Eagle Vision, Inc., Memphis, Tennessee, by telephone August
1, 1994, followed by letter August 15, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 744 scalpels were distributed.
REASON The device is labeled for reuse, however, the polymer
sleeve melts during sterilization in an autoclave.

_______________
PRODUCT NRS-2 and NRS-4 Electroencephalograph Biofeedback Systems.
Recall #Z-391/392-5.
CODE All serial numbers.
MANUFACTURER Lexicor Medical Technology, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, March 8, 1994. Firm-initiated recall ongoing.

-12-DISTRIBUTION Nationwide and international.
QUANTITY Approximately 130 units.
REASON Some units may have been manufactured with the ground and
reference inputs connected together. This may cause a
simulated shift in reference electrode placement.

_______________
PRODUCT: Model 1089 mk II Checktrode Electrode Tester. used to
measure the amount of impedance between the skin and the
electrode, and is distributed as an accessory to the NRS-2,
NRS-4 and the NRS-24 EEG biofeedback systems.
Recall #Z-393-5.
CODE: Serial numbers: 9298, 9299, 92100, 92101, 92102, 92121,
92122, 92123, 92124, 92125, 92126, 92127, 92128, 92129,
92130, 92131, 92132, 92133, 92139, 92140, 92141, 92142,
92143, 92144, 92161, 92162, 92163, 92164, 92195, 92196,
92197, 92198, 92199, 92210, 92211, 92212, 92214, 92215,
92216, 92217, 92219, 92220, 92221, 92222, 92223, 92224,
92225, 92226, 92227, 92228, 92229.
MANUFACTURER UFI, Morro Bay, California.
RECALLED BY Lexicor Medical Technology, Inc., Boulder, Colorado, by
letter February 18, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Italy, Germany, Norway, Japan, Canada, Mexico,
Israel.
QUANTITY 36 units were distributed.
REASON Some units may have been manufactured with grossly shorter
battery life, electrode impedance readings which are erratic
or which bounce between several numbers, and test reading
below normal value (49-51k).

MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT TB Medium in 20 ml bottles, used in the BACTEC 460 TB
analyzer. Safety Alert #N-013-5.
CODE All codes manufactured between 8/93 and 10/94.
MANUFACTURER Kimble Glass, also known as Owens-Illinois, Chicago Heights,
Illinois (glass bottles).
RECALLED BY Becton Dickinson Diagnostic Instrument Systems, Sparks,
Maryland (manufacturer/alerting firm of finished product),
by letter on or about November 18, 1994.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Defective bottles. Bottles may have cracks or bubbles
greater than 3-5 mm in size and may have unusually thin wall
in bottom of bottles.

_______________
PRODUCT Vacutainer brand Blood Collection Sets:
(a) 12" Tubing with Luer Adapter, Catalog numbers 4919,
7251, 7253, 7255;
(b) 5" Tubing with Luer Adapter, Catalog numbers 6251, 6253,
6255;
-13- (c) 12" Tubing without Luer Adapter, Catalog numbers 7250,
7252, 7254;
(d) Single Sample Adapter, Catalog 5731.
(e) Multiple Sample Adapter, Catalog #7290.
Safety Alert #N-014/018-5.
CODE All lot numbers manufactured from January 1991 through
October 15, 1992.
MANUFACTURER Becton Dickinson and Company, Rutherford, New Jersey.
ALERTED BY Manufacturer, by letters of February 7, 1992, and October
15, 1992.
DISTRIBUTION Nationwide and international
QUANTITY 30,129,000 units were shipped.
REASON There is blood leakage from the Leur Adapter Needle when a
needle holder is not used as specified in the labeling.

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END OF ENFORCEMENT REPORT FOR FEBRUARY 15, 1995. BLANK PAGES MAY
FOLLOW.

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