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.
November 5, 1997 97-45
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Frozen Fresh Escargot in 20 ounce box
containing 2 10-ounce vacuum packaged bags.
Recall #F-076-8.
CODE All codes manufactured on or before June 27,
1997.
MANUFACTURER Escargot International, Inc., Addison, Texas.
RECALLED BY Manufacturer, by letter on August 18, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Colorado, Florida, Georgia, Illinois, Kansas,
Louisiana, New Hampshire, New Jersey, New
York, Oregon, Pennsylvania, Texas, Washington,
and the District of Columbia.
QUANTITY 1,164 boxes were distributed.
REASON Product may be contaminated with Listeria
monocytogenes.
______________
UPDATE Recall #F-031-8, Oriental Mascot brand Dried
Sweet Potato, which appeared in the October
29, 1997, Enforcement Report should read:
Completed recall resulted from sample analysis
and follow-up by the New York State Department
of Agriculture and Markets.
_______________
PRODUCT Alfalfa Sprouts and Spicy Sprouts (a mixture
of alfalfa sprouts and radish sprouts.
Recall #F-084/085-8.
CODE Not coded. All product shipped prior to
February 25, 1997.
MANUFACTURER Fuji Natural Foods, Inc., Ontario, California.
RECALLED BY Manufacturer, by letter on February 27 & 28,
1997. State of California/Department of
Health Services issued a press release (#20-97)
on March 7, 1997. Firm-initiated recall
complete.
DISTRIBUTION California, Arizona, Colorado, Utah, New
Mexico.
QUANTITY Firm estimates none remains on the market.
REASON The alfalfa sprouts were found contaminated
with Salmonella oranienburg.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Wilson Farms brand Diet Cola, in 2 liter
plastic bottles. Recall #F-072-8.
CODE All lots beginning with V7203.
MANUFACTURER Cott Beverages, Mississauga, Ontario, Canada.
RECALLED BY Tops markets, Inc., Williamsville, New York,
by telephone and E-mail or fax on September 3,
1997. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 2,800 cases (6 bottles per case) were
distributed.
REASON The product is misbranded, in that it's
labeled as "Diet" but actually contains
sweetened product.
_______________
PRODUCT Bakers Instant Active Dry Yeast, in 1 pound
packages, used by bakeries for baking bread
and pastries. Recall #F-077-8.
CODE Lot numbers: 690 691 692 693
698 699 700 702
703 708 709 710.
MANUFACTURER Levaduras Universal, Guatemala.
-2-
RECALLED BY Red Star de Puerto Rico, Carolina, Puerto
Rico, by telephone or by visit on September 11
& 12, 1997. Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 5,688 pounds were distributed; firm estimates
none remains on the market.
REASON Product may be contaminated with salmonella.
_______________
PRODUCT Children's Chewable Vitamins w/Iron, Cherry,
in bottles of 100. Recall #F-083-8.
CODE Lots 5552-1 & 5552-2.
MANUFACTURER Archon Vitamin Corporation, Irvington, New
Jersey.
RECALLED BY Manufacturer, by letter on July 23, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Michigan, Russia, Germany.
QUANTITY 16,093 bottles were distributed.
REASON Product contains excessive levels of lead.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Mrs. Clark's Foods Spaghetti Sauce packaged in
clear, rigid 1-gallon plastic containers.
The product is labeled as containing
commodities donated by the U.S.D.A., and "Not
To Be Sold Or Exchanged". Recall #F-065-8.
CODE 7216CBA.
MANUFACTURER Mrs. Clark's Foods, Inc., Ankeny, Iowa.
RECALLED BY Manufacturer, by telephone and fax dated
September 3, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nebraska.
QUANTITY 632 4-gallon cases were distributed.
REASON Product is held in swollen and leaking
containers and is contaminated.
_______________
PRODUCT Old El Paso Salsa: a) Old El Paso Thick 'N
Chunky Salsa, Extra Mild, Net Weight 20 ounces
b) Old El Paso Thick 'N Chunky Salsa, Mild,
Net Weight 20 ounces
c) Old El Paso Thick 'N Chunky Salsa, Medium,
Net Weight 20 ounces
d) Old El Paso Thick 'N Chunky Salsa, Hot, Net
Weight 20 ounces. Recall #F-066/069-8.
CODE All codes beginning with H7N27, H7N28, H7N29,
I7N03, I7N04, I7N05.
MANUFACTURER Pillsbury North America, Vineland, New Jersey.
RECALLED BY The Pillsbury Company, Minneapolis, Minnesota,
by electronic mail on October 2, 1997.
Firm-initiated recall ongoing.
-3-
DISTRIBUTION Eastern United States and as far west a the
Rocky Mountains and Colorado.
QUANTITY 1,682 cases containing 12 20-ounce bottles
were distributed.
REASON The products are spoiling.
_______________
PRODUCT Hi-C Wildberry Fruit Drink, in 36 ounce metal
cans. Recall #F-075-8.
CODE Package: W722OCT104, Case: WILDBERRY1180 xx:xx
08 08 97 G20246E.
MANUFACTURER The Minute Maid Company, Geneva, Ohio.
RECALLED BY The Minute Maid Company, Houston, Texas, by
letter on October 24, 1997. Firm-initiated
recall complete.
DISTRIBUTION Connecticut, Iowa, Illinois, Indiana,
Massachusetts, Maryland, Michigan, Minnesota,
North Dakota, Nebraska, New Jersey, New York,
Pennsylvania, Rhode Island, Wisconsin.
QUANTITY 7,180 were distributed.
REASON Some product was manufactured without
sweetener.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Esgic Tablets (Butalbital 50 mg/Acetaminophen
325 mg/caffeine 40 mg), in 500 count bottles,
Rx for the relief of the symptom complex of
tension (or muscle contraction) headache, .
Recall #D-026-8.
CODE GE395F EXP 12/97
GE396F EXP 12/97
GE397F EXP 12/97
GE398F EXP 9/97
GE399F EXP 3/98.
MANUFACTURER Graham Laboratories, Inc., Hobart, New York.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis,
Missouri, by letter dated July 30, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,559 bottles were distributed.
REASON Dissolution failure.
_______________
PRODUCT Aspirin Tablets, 325 mg, packed in blister
cards of 31 tablets per card, OTC analgesic
(NDC #6139289931). Recall #D-029-8.
CODE Lot #5794 EXP 4/5/98.
MANUFACTURER LNK International, Hauppauge, New York.
RECALLED BY Heartland Healthcare Services, Toledo, Ohio,
by telephone on October 17, 1997.
Firm-initiated recall ongoing.
-4-
DISTRIBUTION Ohio.
QUANTITY 198 blister cards containing 31 individual
unit dose aspirin tablets were distributed.
REASON Mislabeling - Uncoated tablets labeled as
"enteric coated".
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Ativan Injection (Lorazepam), 2 mg/ml, 1 ml in
2 ml syringes, packages of 10, Rx indicated
for use in adult patients for preanesthetic
medication, producing sedation, relief of
anxiety, and a decreased ability to recall
events related to the day of surgery
(NDC #0008-0581-06). Recall #D-024-8.
CODE Lot #4970147 EXP 4/99.
MANUFACTURER Wyeth Ayerst Laboratories, West Chester,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on September 3,
1997, followed by fax on September 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kentucky and Indiana.
QUANTITY 60 packages were distributed.
REASON Product leakage from syringe.
_______________
PRODUCT Betuline Lotion (Methyl Salicylate, Camphor,
Menthol), in 2 fluid ounce bottles, OTC
indicated for temporary relief from minor
aches and pains (NDC 0496-0509-06).
Recall #D-025-8.
CODE Lot #57-015 EXP 01/99.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale,
Michigan.
RECALLED BY Manufacturer, by letter on October 14, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 17,792 bottles were distributed.
REASON Superpotency - methyl salicylate (stability).
_______________
PRODUCT Senna Gen Tablets (laxative-senna
concentrate/sennosides), packaged as 30, 32,
or 60 individual unit dosages per blister card
(NDC #00182100910, NDC #6139200839, NDC
#613900832, NDC #6139200835). Recall #D-027-8.
CODE LOT #5480, EXP 2/18/98 (blister cards of 30
and 32 tablets); and LOT #5599, EXP 2/22/98
(blister cards of 60 tablets).
MANUFACTURER Concord Labs, Fairfield, New Jersey.
-5-
RECALLED BY Heartland HealthCare Services, Toledo, Ohio
(repacker/responsible firm), by telephone on
October 17, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Connecticut, Illinois, Washington, Oregon,
Kansas, Ohio, Massachusetts, Missouri,
Oklahoma, Iowa.
QUANTITY A total of 113/60 tablet unit dose blister
cards; 351/30 tablet unit dose blister cards;
and 273/32 tablet unit dose blister cards,
were distributed.
REASON Incorrectly declared potency - Product labeled
as containing 187 mg Senna Concentrate (5.6 mg
Sennosides), but actually contains 8.6 mg
Sennosides.
_______________
PRODUCT Estring (Estradiol Vaginal Ring), 2 mg, Rx,
indicated for the treatment of urogenital
symptoms associated with post-menopausal
atrophy of the vagina and/or the lower urinary
tract (NDC 0013-2150-36). Recall #D-028-8.
CODE Lot numbers: XE817A and XE848A, EXP 4/30/98.
MANUFACTURER Ferring AB, Malmo, Sweden (contract
manufacturer).
RECALLED BY Pharmacia & Upjohn, Kalamazoo, Michigan, by
letter on October 27, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 6,011 units were distributed between January
27 and May 5, 1997.
REASON Stability cannot be assured through expiry
date.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Source Plasma. Recall #B-050-8.
CODE Unit 72754252.
MANUFACTURER Bio-Blood Components, Inc., Hammond, Indiana.
RECALLED BY Manufacturer, by letter on July 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had ear piercing within twelve months of
donation.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-065/066-8.
CODE Unit 16LG03186.
-6-
MANUFACTURER American Red Cross Blood Services, Columbus,
Ohio.
RECALLED BY Manufacturer, by letter dated May 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a Measles, Mumps and Rubella (MMR)
vaccine within two weeks of donation.
_______________
PRODUCT a) Red Blood Cells. Recall #B-070-8.
CODE Unit numbers: 3213477 and 3213483
MANUFACTURER Sylvan N. Goldman Center Oklahoma Blood
Institute, Oklahoma City, Oklahoma.
RECALLED BY Manufacturer, by fax on December 12, 1995.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 2 units were distributed.
REASON Blood products were prepared from units of
Whole Blood which remained at room temperature
for an unacceptable length of time.
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma;
d) Cryoprecipitated AHF
e) Recovered Plasma. Recall #B-072/076-8.
CODE The blood components are identified with one
of the following Whole Blood Numbers:
24KE01978, 24LG59026, 24LG82438, 24LH02286,
24LH56582, 24LH61812, 24LH66486, 24LH68873,
24LM22263, 24LM42344, 24LM61200, 24LM69015,
24LM84556, 24LQ51895, 24LQ52949, 24LQ65297,
24LS55346, 24LS57269, 24LY00872, 24LY26987.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letters dated October 16 and
20, 1995, and July 7, 1997, and by telephone
on July 8, 1997. Firm-initiated recall
complete.
DISTRIBUTION Kentucky, Illinois, Switzerland.
QUANTITY a) 20 units; b) 12 units; c) 8 units
d) 4 units; e) 12 units were distributed.
REASON Blood products tested repeatedly reactive for
the antibody to the human immunodeficiency
virus type 1 (anti-HIV-1), or which tested
negative for anti-HIV-1, but were collected
from a donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
indeterminate.
-7-
_______________
PRODUCT Red Blood Cells. Recall #B-080-8.
CODE Unit 04KF81162.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated October 10,
1996. Firm-initiated recall complete.
DISTRIBUTION New Hampshire.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT Platelets, Pheresis. Recall #B-082-8.
CODE Unit numbers: 10509-6684 10514-6643
10510-7458 10509-6921 10515-7555
10517-8076 10515-7447 10515-7979
10515-7452 10509-6952 10517-8069
10509-6906 10509-6901 10517-4832
10517-4824 10515-7509 10516-7139
10509-6917 10517-4866 10516-7030
10516-7041 10515-7448 10516-7044
10517-6576 10516-7040 10517-8073
10516-7074 10515-7433 10517-4839
10509-6912 10516-7075.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on October 7, 1996, followed by
letter dated December 5, 1996. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Missouri, Arizona.
QUANTITY 31 units were distributed.
REASON Blood products had an elevated platelet count.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-035-8.
CODE Unit #11316-2795.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on June 3, 1997, followed by letter
dated July 2, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of
whole blood with an extended collection time
and designated as a difficult collection.
-8-
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-051-8.
CODE Units 18S48219, 18S48221, 18Q79679, 18Q79710.
MANUFACTURER American Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by telephone and letter issued
on April 23, 1996. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 4 units were distributed.
REASON Blood products were stored at unacceptable
temperature.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh
Frozen Plasma. Recall #B-052/054-8.
CODE Unit #50F51368.
MANUFACTURER American Red Cross Blood Services, Toledo,
Ohio.
RECALLED BY Manufacturer, by telephone on July 1, 1997,
and by letter dated July 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio and Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
who received a tissue transplant (surgery)
within a year of donation.
_______________
PRODUCT Recovered Plasma. Recall #B-071-8.
CODE Unit numbers 3213477 and 3213483.
MANUFACTURER Sylvlan N. Goldlman Center, Oklahoma Blood
Institute, Oklahoma, City, Oklahoma.
RECALLED BY Manufacturer, by fax on December 12, 1995.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 2 units were distributed.
REASON Blood products were prepared from units of
Whole Blood which remained at room temperature
for an unacceptable length of time
_______________
PRODUCT Irradiated Red Blood Cells. Recall #B-081-8.
CODE Unit #04FS68669.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by telephone on July 3, 1996,
followed by letter dated July 23, 1996.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date after irradiation, was
distributed.
-9-
_______________
PRODUCT Irradiated Red Blood Cells. Recall #B-083-8.
CODE Unit 04S87117.
MANUFACTURER American Red Cross Blood Services, Dedham,
Massachusetts.
RECALLED BY Manufacturer, by telephone on January 14,
1997. Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for
greater than 30 minutes during irradiation.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=========
_______________
PRODUCT Maxx 250 ml Reservoir with Attached 200 ml/hr
Tubing, 1.2 micron Air Eliminating Filter,
Distal Male Luer, Roblets Clamp and Fill Port,
Rx sterile disposable I.V. fluid delivery
system. Recall #Z-012-8.
CODE Lot 63533.
MANUFACTURER Medication Delivery Devices, Inc., a
subsidiary of Baiter Healthcare Corporation,
San Diego, California.
RECALLED BY Baiter Healthcare Corporation, I.V. Systems
Division, Round Lake, Illinois, by fax dated
September 29, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 116 cases were distributed.
REASON The units labeled with a flow rate 200 ml/hr
may actually have a 100 ml/hr flow restrictor
in the disposable tubing.
_______________
PRODUCT Mini Lead Aprons, Aprons, Lead Sheeting,
Mobile Protective Shield, Protecta Pad and
Thyroid Shields:
a) Aprons
Alimed item numbers 9-080, 9-081, 9-082, 9-083
9-203, 9-207, 9-221, 9-222, 9-223, 9-227,
9-316, 9-332 920117, 920118, 920119, 920121
B.T. Medical item numbers: 9-287, 9-346,
9-348, 9-584 91-202, 91-203, 91-213,
91-214, 920104, 920106, 920107, 920108,
920109, 920111 920112, 920123, 920124, 920126,
920127, 920261 920438, 920439, 920441, 920442,
920517, 920518, 920519, 920523, 920524,
920525, 95-568
Bar-Ray Item Number: 9-623
b) Lead Blocker Sheet
-10-
Alimed item numbers: 9-466, 9-467, 9-468,
9-469, 9-470, 9-471, 9-472, 9-473, 9-474,
9-487
Bar-Ray item number: 920558
c) Shields
Alimed item numbers: 9-475, 9-590, 9-654,
920483
Bar-Ray item numbers: 91-255, 91-256
d) Vestskirt
B.T. Medical item numbers: 91-205, 91-206.
These products were manufactured from January
1, 1997 through May. Recall #Z-032/035-8.
CODE Product purchased between January 1, 1997
through May 1997.
MANUFACTURER The Kennedy Company, Scottsboro, Alabama
(supplier of contaminated lead vinyl).
RECALLED BY AliMed, Inc., Dedham, Massachusetts, by letter
on June 23, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Japan.
QUANTITY 437 units were distributed.
REASON The radiation protection devices contain lead
contamination with small amounts of
radioactive substances.
_______________
PRODUCT Portable oxygen units, used to provide a
portable source of oxygen to the patient for
extended periods of time: a) Caire Top Fill
50 psi Stroller (portable) oxygen unit, 1.2
liter; b) Lincare Sur-Cal III, 50 psi
(portable) Oxygen Unit, 0.6 liter; c) Linecare
Sur-Cal III, 50 psi (portable) Oxygen Unit,
1.2 liter; d) Lincare Mark X (portable) Oxygen
Unit, 1.2 liter. Recall #Z-043/046-8.
CODE a) Product Number 10677517; Product Number
10669162; c) Product Number 10678229; d)
Product Number 10561987.
MANUFACTURER Caire, Inc., Burnsville, Minnesota.
RECALLED BY Manufacturer, by letter on October 9, 1997.
Firm-initiated field correction (retrofit)
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,646 units.
REASON Too small of an orifice prior to the primary
relief valves can result in flow of liquid
oxygen into the nasal canula and
frostbite/burns to the patient. A release of
pressure may occur when an oxygen unit tips
over or when there is a vacuum failure of the
cryogenic unit.
-11-
_______________
PRODUCT Laser Lancet LB100 Er:YAG Laser Perforator, a
skin perforator. Recall #Z-048-8
CODE None.
MANUFACTURER TransMedica International, Little Rock,
Arkansas.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on October 7, 1997.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 11 units were distributed.
REASON The devices failed to comply with 21 CFR
1040.10(h)(1)(iii) and 1040.11(a)(2), labeling
noncompliances.
_______________
PRODUCT Ultra-Flex Adult Anesthesia Breathing
Circuits. Recall #Z-049/153-8.
CODE 1. Product No. 047542, Lot No. 1030G7;
2. Product No. OQ81213B-32831X,
Lot Nos. 0463J7, 1588H7;
3. Product No. 30010, Lot No. 1432G7;
4. Product No. 47511A, Lot No. 1145H7;
5. Product No. 47513, Lot Nos. 0210H7,
0398H7;
6. Product No. 47523, Lot Nos. 0399H7,
0733J7, 1153H7;
7. Product No. 51213F-14621, Lot No.0869J7;
8. Product No. 51213F-1468, Lot No. 0870J7;
9. Product No. 5413F-84Z, Lot No. 0400H7;
10. Product No. 5613B-80X, Lot Nos. 0606G7,
06737H7, 0648H7, 1126G7, 1154H7, 1522H7;
11. Product No. 5613F-26, Lot Nos. 0309H7,
1155H7, 1247G7, 1790G7;
12. Product No. 5753B-61Z, Lot No. 1020H7;
13. Product No. 5753F-140X, Lot No. 0378J7;
14. Product No. 5903F-14621, Lot No. 0305H7;
15. Product No. 5753F-61, Lot Nos. 0608G7,
0853H7, 1341H7;
16. Product No. 5753F-6127, Lot No. 0868H7;
17. Product No. 5903F-61, Lot Nos. 0102H7,
0816G7, 1429H7, 1559G7;
18. Product No. 61213B-618, Lot No. 1260H7;
19. Product No. 61213F-6154, Lot No. 1257H7;
20. Product No. 6413B-6115, Lot Nos. 1156H7,
1431H7;
21. Product No. 6413B-6121, Lot Nos. 0126J7,
0552H7, 1157H7, 1432H7, 1538G7;
22. Product No. 6613F-84X, Lot No. 0786H7;
23. Product No. 6753B-6133, Lot Nos. 0127J7,
0553H7, 0625J7, 0708G7;
24. Product No. 6753F-61, Lot Nos. 1043H7,
1560G7;
-12-
25. Product No. 81213B-61, Lot Nos. 0128J7,
1026G7, 047J7, 1478H7;
26. Product No. 81213F-61, Lot Nos. 0105H7,
0204H7, 0292H7, 0554H7, 0871J7, 1044H7,
1250G7, 1342H7, 1561G7;
27. Product No. 81510B-06, Lot No. 0611G7;
28. Product No. 8412B-61, Lot Nos. 0682G7,
0787H7, 01416G7, 1416G7, 1433H7;
29. Product No. 8412F-61, Lot No. 0859H7;
30. Product No. 8412F-61Z, Lot No. 0505J7;
31. Product No. 8413B-61, Lot Nos. 0256J7,
0308H7, 0886H7;
32. Product No. 8413F-14721, Lot No. 0788H7;
33. Product No. 8413F-61, Lot Nos. 1158H7,
1774H7;
34. Product No. 8413F-61X, Lot No. 1128G7;
35. Product No. 8413F-6133, Lot Nos. 0489H7,
0626J7;
36. Product No. 8421B-61, Lot No. 0458J7;
37. Product No. 8610B-61, Lot No. 0379J7;
38. Product No. 8610B-61 RIKO, Lot No. 1466G7;
39. Product No. 8612F-61, Lot Nos. 0106H7,
0555H7, 1716H7;
40. Product No. 8612F-80M, Lot Nos. 0310J7,
0612G7, 1434H7;
41. Product No. 8613B-61, Lot Nos. 0627J7,
0887G7;
42. Product No. 8613F-61X, Lot Nos. 0206H7,
0614G7, 0886G7;
43. Product No. 8613F-6127, Lot No. 1446G7;
44. Product No. 8613F-80, Lot Nos. 1037F7,
1343E7, 1953E7, 0309H7, 0460J7, 0711G7,
0888H7, 1046H7, 1132G7, 1343H7;
45. Product No. 8750B-61, Lot No. 1409F7;
46. Product No. 8752B-08BZ, Lot Nos. 0557H7,
0629J7, 1159H7, 1447G7;
47. Product No. 8752F-164E, Lot No. 0742H7;
48. Product No. 8753B14039, Lot Nos. 0107H7,
0191J7, 0630J7, 0709H7, 1261H7;
49. Product No. 8752F-6121, Lot No. 1254G7;
50. Product No. 8753B-6131, Lot Nos. 1028G7,
0108H7, 1255G7;
51. Product NO. 8753B-6157X, Lot Nos. 0207H7,
1160H7, 1256G7;
52. Product No. 8753B-71, Lot No. 1133G7;
53. Product No. 8753B-80, Lot Nos. 0781J7,
1564G7;
54. Product No. 8753F-136, Lot Nos. 0792H7,
1029G7, 1134G7, 1565G7;
55. Product No. 8753F-13639, Lot Nos. 0890H7,
1257G7;
56. Product No. 8753F-187, Lot No. 0109H7;
-13-
57. Product No. 8753F-248T21, Lot Nos. 1262H7,
1362G7;
58. Product No. 8753F-26, Lot No. 1567G7;
59. Product No. 8753F-26X, Lot Nos. 0208H7,
0977F7, 1162H7, 1259G7;
60. Product No. 8753F-284, Lot No. 1163H7;
61. Product No. 8753F-6114, Lot Nos. 0209H7,
0492H7, 1260G7;
62. Product No. 8753F-6124, Lot No. 0658J7;
63. Product No. 8753F-71, Lot No. 0425J7;
64. Product No. 8753F-80, Lot Nos. 0130J7,
0260J7, 1041F7, 1135G7, 1528H7;
65. Product No. 8753F-80X, Lot No. 0793H7;
66. Product No. 8753F-8021, Lot No. 1263H7;
67. Product No. 8903B-164, Lot No. 1164H7;
68. Product No. 8903B-16421, Lot Nos. 0261J7,
0782J7, 0794H7, 1264H7, 1370H7, 1568G7;
69. Product No. 8903B-19939S, Lot No. 0507J7;
70. Product No. 8903B-61, Lot Nos. 0110H7,
0493H7;
71. Product No. 8903F-136, Lot Nos. 0462J7,
0795H7;
72. Product No. 8903F-164, Lot No. 0794G7;
73. Product No. 8903F-187, Lot Nos. 0310H7,
0782J7;
74. Product No. 8903F-30SB, Lot Nos. 0891H7;
75. Product No. 8903F-23621, Lot No. 1231G7;
76. Product No. 8903F-23633, Lot No. 0632J7;
77. Product No. 8903F-61, Lot No. 0426G7,
0662H7, 0817G7, 1136G7, 1569G7;
78. Product No. 90082, Lot Nos. 1038H7,
1437G7;
79. Product No. 90106, Lot Nos. 1039H7,
1438G7;
80. Product No. 90132, Lot Nos. 0762H7;
81. Product No. 90154, Lot Nos. 0131J7;
82. Product No. 90164, Lot No. 0298H7;
83. Product No. 90187, Lot No. 0302C7, 0713G7,
0784J7, 1529H7;
84. Product No. 90297, Lot No. 0894H7, 1347H7;
85. Product No. 90312, Lot No. 1013H7;
86. Product No. 90316, Lot Nos. 0262J7,
0311H7, 0663H7, 0889G7, 1261G7, 1265H7;
87. Product No. 90323, Lot Nos. 1239H7,
1439G7;
88. Product No. 90346, Lot Nos. 0656H7,
0948G7, 1253G7;
89. Product No. 90353, Lot Nos. 0124J7,
0499G7, 0867H7, 1023G7, 507F7;
90. Product No. 90389, Lot Nos. 1036J7,
1273J7, 1508H7;
91. Product No. 90396, Lot No. 0111H7;
-14-
92. Product No. 90405M, Lot Nos. 0210H7,
0555J7, 0617G7, 1166H7, 1719H7;
93. Product No. 90426, Lot Nos. 0514G7,
0664H7, 0890G7, 1319G7;
94. Product No. 90428, Lot No 0675F7;
95. Product No. 90442, Lot Nos. 0175J7,
0312H7, 1310G7;
96. Product No. 90444, Lot Nos. 0313H7,
0556J7;
97. Product No. FGL8753B-06X, Lot No. 1266H7;
98. Product No. H5413F-61, Lot Nos. 0193J7,
0618G7, 0626H7, 1253H7, 1264G7, 1797H7;
99. Product No. H5903B-61XP, Lot Nos. 0403H7,
0513J7, 0619G7, 1137G7, 1348H7;
100. Product No. H6413F-61X, Lot Nos. 0314H7,
0896H7, 1570G7;
101. Product No. L8752B-08B, Lot Nos. 0796H7,
1325H7;
102. Product No. M8613B-06, Lot Nos. 1138G7,
1571G7;
103. Product No. R6753F-8021, Lot No. 1530H7;
104. Product No. R6753F-80XP,
Lot Nos. 0212H7, 1167H7;
105. Product No. R6903B-164, Lot No. 1713G7.
MANUFACTURER King Systems Corporation, Noblesville,
Indiana.
RECALLED BY Manufacturer, by verbally or by letter on
August 11, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,965 cases of 30 units each were distributed.
REASON The expandable tube is breaking around the
circumference of the tube.
_______________
UPDATE Ultra-Flex brand Adult Anesthesia Breathing
Circuits, Recall #Z-915/941-7, which appeared
in the October 1, 1997, Enforcement Report has
been extended to include the following lot
numbers with the following listed Recall
Numbers:
Z-915-7 - Product No. 5213F-6154, Lot No.
1246F7;
Z-916-7 - Product No. 5613B-61, Lot Nos.
1340H7, 1357G7;
Z-917-7 - Product No. 5613F-61, Lot Nos.
0705G7, 0883H7, 1587H7, 1764H7;
Z-918-7 - Product No. 5613F-80, Lot Nos.
0238F7, 0401H7, 1248G7;
Z-919-7 - Product No. 5753B-61, Lot Nos.
0456J7, 0706G7, 1005H7, 1249G7;
Z-920-7 - Product No. 5753F-10021, Lot Nos.
0202H7, 0255J7, 0607G7, 1024G7, 1428H7;
-15-
Z-922-7 - Product No. 6753F-13621, Lot Nos.
0540J7, 0610G7, 0885H7, 0960G7, 1358G7;
Z-923-7 - Product No. 8613B-164, Lot Nos.
1130G7, 1341E7;
Z-924-7 - Product No. 8613B-84X, Lot Nos.
0190J7, 0624H7, 0709G7, 1027G7, 1045H7,
1435H7, 1445G7;
Z-925-7 - Product No. 8613F-13633, Lot Nos.
0258J7, 0789H7, 1359G7, 1436H7, 1717H7;
Z-926-7 - Product No. 8613F-164E, Lot Nos.
0218G7, 0657J7, 0660H7, 0961G7, 1437H7,
1457H7;
Z-927-7 - Product No. 8613F-61, Lot Nos.
0205H7, 0219G7, 0402H7, 0490H7, 0556H7,
0628J7, 0701G7, 0710G7, 1131G7, 1360G7,
1525H7, 1798H7;
Z-928-7 - Product No. 8613F-6121, Lot No.
0615G7;
Z-930-7 - Product No. 8613F-84, Lot Nos.
1361G7, 1526H7;
Z-931-7 - Product No. 8613F-8433, Lot Nos.
1562G7;
Z-933-7 - Product No. 8753B-61, Lot Nos.
0508G7, 0791H7, 1021G7, 1283F7, 1527H7,
1563G7;
Z-934-7 - Product No. 8753F-104, Lot No.
0889H7;
Z-936-7 - Product No. 8753F-248, Lot Nos.
0558H7, 1161H7, 1566G7;
Z-937-7 - Product No. 8753F-249, Lot Nos.
0542G7, 0661H7, 0712G7, 0887G7, 1047H7,
1258G7, 1292H7, 1323H7, 1346E7, 1718H7;
Z-938-7 - Product No. 8753F-61, Lot Nos.
0129J7, 0491H7, 0631J7, 0692G7, 0888G7,
1413F7;
Z-939-7 - Product No. 90337, Lot Nos. 0494H7,
1262G7;
Z-941-7 - Product No. Q5753F-28B31, Lot Nos.
0665H7, 0715G7.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Stratus hCG Fluorometric Enzyme Immunoassay,
Catalog No. B5700-55, for use in the
determination of hCG levels in serum or
plasma. Recall #Z-028-8.
CODE Lot #KXHG-3068.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter on March 14, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 200 kits were distributed.
-16-
REASON The calibrator produces high control recovery
and a shift up in hCG values.
_______________
PRODUCT Stratus CK-MB Fluorometric Enzyme Immunoassay
Catalog Nos. B5700-60 (120 test) and B5700-60S
(60 test), intended for use in the
determination of CK-MB levels in human serum:
a) Catalog #B5700-60 Test Kit Size - 120 Tests
b) Catalog #B5700-60S, Test Kit Size - 60
Tests. Recall #Z-029/030-8.
CODE Lot Numbers: a) KXMB-2885 through 2916, 2918
through 2922, 2929, 2933, 2934, 2947
b) KXMB-261S and 264S.
MANUFACTURER Dade International Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter on July 9, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 11,943 kits were distributed.
REASON The conjugate is producing high calibrator A
rates and high control recovery for the low
level control.
_______________
PRODUCT Technicon H Systems RBC DIL, Product No.
T01-1570-56, used to quantitate RBC's and
platelets in blood.
Recall# Z-036-8.
CODE Lot No. V01894X.
MANUFACTURER Bayer Corporation, Middletown, Virginia.
RECALLED BY Manufacturer, by letter in August 1997.
Firm initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 779 units were distributed.
REASON There is particulate matter in some bottles of
this lot.
_______________
PRODUCT Bartels Epstein-Barr Virus IgG Enzyme
Immunoassay, Catalog #B1029-360, intended for
the qualitative detection of IgG antibody to
the viral capsid antigen of Epstein-Barr virus
in human serum. Recall #Z-037-8.
CODE Lot #2090, EXP 10/98.
MANUFACTURER Gull Laboratories, Inc., Salt Lake City, Utah.
RECALLED BY Bartels Inc., The Diagnostic Division of
Intracel Corporation, Issaquah, Washington, by
letter on September 18, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION California, Ohio, Pennsylvania, Iowa,
Kentucky, New York, Delaware, Washington
state, Illinois, Puerto Rico.
QUANTITY 200 were distributed between 6/16/97 and
9/9/97.
-17-
REASON The conjugate is losing stability resulting in
absorbance values for the reference, and
positive control that are lower than the
limits specified in the product insert.
_______________
PRODUCT Stratus Beta hCG fluorometric Enzyme
Immunoassay, Catalog #B5700-59, intended for
use in the determination of total beta human
chorionic gonadotropin levels in serum or
plasma. Recall #Z-154-8.
CODE Lot #KXBG-396.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter dated February 14,
1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and New Zealand.
QUANTITY 93 kits were distributed.
REASON The calibrator produces high control recovery
and a shift up in beta hCG values.
_______________
PRODUCT Bartels Cytomegalovirus IgM Enzyme
Immunoassay, Catalog No. B1029-335, intended
for the qualitative detection of 1gM
antibodies to cytomegalovirus in human serum.
Recall #Z-155-8.
CODE Lot No. 2094.
MANUFACTURER Gull Laboratories, Inc., Salt Lake City, Utah
(Elisa Test).
RECALLED BY Bartels, Inc., Issaquah, Washington, by letter
on October 10, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and Australia.
QUANTITY 45 kits were distributed.
REASON The conjugate is losing stability resulting in
absorbance values for reference and positive
control that are lower than the limits
specified in the product insert.
-18-
END OF ENFORCEMENT REPORT FOR NOVEMBER 4, 1997. BLANK PAGES MAY FOLLOW.
####
End of Enforcement Report for
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