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.
April 29, 1998 98-17
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Queso Blanco Cheese: a) Petite Round Queso Blanco
Cheese; b) Mini Round Queso Blanco Cheese (Note:
these were labeled by the distributor, Universal
Food & Dairy Products, Hialeah, FL as "El
Venadito" brand).
Recall #F-451/452-8.
CODE All codes.
MANUFACTURER Specialty Cheese Company, Inc., Lebanon,
Wisconsin.
RECALLED BY Specialty Cheese Company, Inc., Lowell, Wisconsin
on March 26, 1998, and by press release on March
27, 1998. Completed recall resulted from sample
analysis and follow up by the Florida Department
of Agriculture
DISTRIBUTION Florida.
QUANTITY Firm estimates none remains on the market.
REASON The products may be contaminated with Listeria
monocytogenes.
_______________
PRODUCT Basha Foods brand Hommus Vegetable packaged in
plastic containers. Recall #F-453-8.
CODE Lot #3 20 112.
MANUFACTURER Basha International Foods, Inc., Hamtramck,
Michigan.
RECALLED BY Manufacturer, by fax and by visit beginning on
March 6, 1998, and by press release on March 8,
1998. Firm-initiated recall complete.
DISTRIBUTION Michigan, Colorado, Illinois, Florida.
QUANTITY 36 cases of 24 8-ounce containers were
distributed.
REASON Product was contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Frozen Yellowfin Tuna, in 10 lb. Cases labeled in
part "***Distributed By Sysco Corporation,
Houston, Texas 77077***" Lot 18403A - 8 oz. Vac
pac, product of Indonesia, packed and distributed
for institutional/restaurant use.
Recall #F-332-8.
CODE Lot #18403A.
MANUFACTURER Trident Seafoods Corporation, Bellingham,
Massachusetts.
RECALLED BY Manufacturer, by letter dated March 13, 1998,
followed by telephone. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON The product caused scombroid poisoning and is
decomposed.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III =========
_______________
PRODUCT Frozen dough and baked goods:
Allied Bakers, Westbury, NY 11590
1. Allied 5-Minute Garlic Bread, 12/1 pound
2. Allied Sliced Marble Bread, 12/16 ounce
Lamb-Weston, Inc., Chicago, IL 60673
3. Tatboy Spud Bites/Puffettes, 6/5 pound
4. Russet Potatoes-Dinner Slices, 6/3/ pound
Beatrice Grocery Group, Chicago, IL 60693
5. LaChoy Egg Rolls-Shrimp, 60/3 ounce & 200
count
Best Maid Cookie Company, River Falls, WI 54022
6. Best Maid Chocolate Chip Preformed Dough,
180/2 ounce
7. Best Maid M&M Chocolate Chip Preformed
Dough, 180/2 ounce
8. Best Maid Oatmeal/Raisin Preformed Dough,
180/2 ounce
9. Best Maid Preformed Sugar Cookie Dough, 180/2
ounce
10. Best Maid Walnut Chocolate Chip Preformed
Cookie Dough, 180/2 ounce
Nugget/Sara Lee, Chicago, IL 60641
11. Nugget Cookies & Cream Pie, 4/38 ounce
12. Nugget 12 x 16 inch Iced Carrot Cake, 3/84
ounce
13. Sara Lee Elite Variety Cheesecake, 4/10 inch
14. Nugget 12 x 16 inch Unsliced Sponge Cake, 4/40
ounce
15. Nugget 95% Fat Free Pound Cake, 12/15 ounce
16. Sara Lee Apple Dumplings, 2/18 count
Karps Bakery Supply, Milwaukee, WI 53204
17. Karps Cinnamon/Pecan Biscotti, 68/1.3
ounce
18. Karps Fudge Macaroon Scrumpts (cookies)
108 count, 1.75 ounce
19. Karps Double Chocolate Biscotti, 68/1.3
ounce
20. Karps Almond Biscotti, 68/1.3 ounce
21. Karps Fudge Macaroon Scrumpts (cookies)
108 count, 1.75 ounce
22. Karps Chocolate Truffle Scrumpts 108
count, 1.75 ounce
23. Karps Blueberry Nibbleniks 180 count, 1.75
ounce
24. Karps Strawberry Cream Cheese Strudelnik,
60/3.2 ounce
25. Karps Apple Nibbleniks 180 count, 1.25
ounce
26. Karps Raspberry Nibbleniks 180 count, 1.25
ounce
Rich Sales Company, Chicago, IL 60693
27. Richs Marble Sheetcake, 12/23 ounce
28. Richs 4 inch Decorated Cake, 12/5 ounce
29. Richs White Bread Dough, 16/27 ounce
30. Richs Home Style Biscuit Dough 216 count,
2.5 ounce
31. Richs Natural Grain Bread Dough, 24/19
ounce
32. Richs Rye Bread Lite Dough, 24/18 ounce
33. Richs Hamburger Roll Dough, 180/2 ounce
34. Richs Wheat Bread Dough, 24/19 ounce
35. Richs Italian Bread Dough, 24/19 ounce
36. Richs Submarine Roll Dough, 72/4 ounce
37. Richs French Bread Sub Roll Dough, 60/6
ounce
38. Richs Wheat Sub Roll Dough, 60/6 ounce
39. Richs Stoneground Wheat Bread Dough, 60/6
ounce
40. Richs European Grain Breadstix, 120/5
ounce
41. Richs Par-Baked Petit Plain Rolls 140/
ounce
42. Richs Potato Flour Donuts, 240/1.75 ounce
43. Richs Old Fashioned Preformed Donuts, 84/2
ounce
44. Richs Long John Shells, 96/2 ounce
45. Richs Apple Turnovers, 80/3.75 ounce
46. Richs Cream Puffs, 48/1.33 ounce
47. Richs Chocolate Eclairs, 48/2 ounce
48. Richs Oatmeal Raisin Cookie Dough, 240/1
ounce
J.R. Simplot Company, Chicago, IL 60693
49. Simplot Conique Potato Original, 4/5 pound
Bran Zan, Inc., Plover, WI 54467
50. Golden Potato Strips, 4/5 pound
Ice Cream Pies/Royalton Foods, Minneapolis, MN
55405
ounce
52. Royalston Assorted Baby Cheese Cakes,
3/35 count
Pappy's Foods, Rock Island, IL 61204
53. Pappy's Angel Food Bars, 18/10 ounce
Pillsbury Bakeries and Foodservice, Chicago, IL
60673
54. Pillsbury Devils Food Shortcake, 12/23 ounce
55. Pillsbury Danish Figure 8's, 84/2.5 ounce
56. Pillsbury Peanut Butter Cookie Dough 288
count, 1.2 ounce
57. Pillsbury M & M Cookie Dough 288 count,
1.2 ounce
58. Pillsbury Baked Buttermilk Biscuit 140
count, 1.2 ounce
59. Pillsbury Peanut Butter with Reeses Cookie
Dough, 216/1.5 ounce
60. Pillsbury Chocolate Chunk Cookie Dough 216
count, 1.5 ounce
61. Pillsbury Chocolate Chunk Chip Cookie
Dough 216 count, 1.5 ounce
62. Pillsbury Chocolate Chip M & M Cookie
Dough 216 count, 1.5 ounce
63. Pillsbury Apple Stik Strudel, 96/2.5 ounce
64. Pillsbury White Chocolate with Macadamia
Nut Cookie Dough 216 count, 1.5 ounce
65. Pillsbury Blueberry Stik Strudel, 96/2.5
ounce
66. Pillsbury Cherry Stik Strudel, 96/2.5
ounce
67. Pillsbury Raspberry Stik Strudel, 96/2.5
ounce
68. Pillsbury Raisin Bran Muffin, 48/4 ounce
69. Pillsbury Banana Nut Muffin, 48/4 ounce
70. Pillsbury Sunrise Muffin, 48 count
71. Pillsbury Lemon Poppy Baked Muffin, 240/1
ounce
72. Pillsbury Orange Blossom Baked Muffins,
240/1 ounce
73. Pillsbury Sunrise Baked Muffin, 96/2.4
ounce
74. Pillsbury Sugar Cookie Dough 216 count,
1.5 ounce
Sparta Foods, Minneapolis, MN 55485
75. Mexito 6 inch Yellow Corn Tortillas, 6/96
count
Sunny Fresh Food, Atlanta, GA 30384
76. Sunny Fresh Folded Egg Pattie 100 count,
1.5 ounce
77. Sunny Fresh Cheese Cholesterol Free
Omelets, 48/3.5 ounce
78. Sunny Fresh Ham & Cheese Skillet Omelets,
48/ 3.5 ounce
79. Sunny Fresh Zero Cholesterol Omelets, 48/3
ounce
80. Sunny Fresh Western Skillet Omelet, 48/3.5
ounce
T.N.T. Crust, Inc., Green Bay, WI 54308
81. TNT Thin 9 inch Pizza Crust, 80 count
82. TNT Thin 14 inch Pizza Crust, 40 count
Anchor Food Products, Inc., Milwaukee, WI 53268
83. Anchor Western Omelet Fill-A-Buster, 6/2
pound
Camden Creek Bakery, Minneapolis, MN 55485
84. Chocolate Chip Cookie Dough, 384/1 ounce
Ventura Foods, Chicago, IL 60694-1610
85. Corn Oil Margarine Reddies (single service
margarine) 12 pound case.
Recall #F-358/442-8.
CODE All product distributed by the recalling firm
since November 1, 1997.
MANUFACTURER Various manufacturers (not responsible for
problem).
RECALLED BY Indianhead Foodservice Distributor, Inc., Eau
Claire, Wisconsin, by telephone on February 26,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin, Michigan, Minnesota.
QUANTITY Approximately 800 cases were distributed; firm
estimated that 150 cases remained on market at
time of recall initiation.
REASON Products are unfit for food due to off-odor and
taste.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
III ==========
_______________
PRODUCT Rugby brand Bromanate Elixir (Bromaline),
(Phenylpropanolamine Hydrochloride 12.5
mg/Brompheniramine Maleate 2 mg), in 4 fluid ounce
bottles, Rx indicated for the temporary relief of
runny nose and sneezing, itching of the nose or
throat, and itchy watery eyes, due to hay fever
and nasal congestion due to the common cold. NDC
#0536-2345-97.
Recall #D-117-8.
CODE Lot #RB 7198 EXP 5/99.
MANUFACTURER Alpharma, U.S. Pharmaceuticals Division,
Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone on March 20, 1998, and
by letter on March 30, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION Georgia.
QUANTITY 60,048 units were distributed.
REASON Superpotent (Brompheniramine Maleate).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======
_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c)
Platelets. Recall #B-848/850-8.
CODE Unit #62-20029.
MANUFACTURER Michigan Community Blood Centers, Saginaw,
Michigan.
RECALLED BY Manufacturer, by letter on March 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a
history of Hashimoto's Disease.
_______________
PRODUCT a) Whole Blood; b) Red Blood Cells
c) Platelets; d) Fresh Frozen Plasma
e) Cryoprecipitated AHF; f) Platelets, for further
manufacture; g) Recovered Plasma.
Recall #B-900/906-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters Dated December 16, 1996,
or July 15 or 16, 1997. Firm-initiated recall
complete.
DISTRIBUTION California, Ohio, Missouri.
QUANTITY a) 1 unit; b) 20 units; c) 10 units; d) 2 units;
e) 2 units; f) 1 unit; g) 18 units were
distributed.
REASON Blood products tested negative for the antibody to
the human immunodeficiency virus type 1
(anti-HIV-1) but were collected from donors who
previously tested repeatedly reactive for
anti-HIV-1, Western blot negative.
_______________
PRODUCT Red Blood Cells. Recall #B-907-8.
CODE Unit #03H05782.
MANUFACTURER American Red Cross Southern Region, Miami,
Florida.
RECALLED BY Manufacturer, by telephone on September 30, 1997,
and by letter dated October 1, 1997.
Firm-initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
suitability was not adequately determined.
_______________
PRODUCT Platelets, Pheresis. Recall #B-910-8.
CODE Unit #06KF14483.
MANUFACTURER American Red Cross Blood Services, Los Angeles,
California.
RECALLED BY Manufacturer, by telephone on October 9, 1996, and
by telephone October 10, 1996. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was suspended in an inadequate
plasma volume.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-914/915-8.
CODE Unit numbers: 4588537, 4588543, 4791103, 4791106,
4791109, 4791111, 4791117, 4791118, 4791121,
4791129, 4791131, 4791154, 4791156, 4791157,
4791158, 4791159.
MANUFACTURER National Naval Medical Center, Bethesda, Maryland.
RECALLED BY Manufacturer, by telephone on February 2 and 10,
1994. Firm-initiated recall complete.
DISTRIBUTION New Jersey and California.
QUANTITY a) 14 units; b) 2 units were distributed.
REASON Blood products were collected from donors whose
arm cleansing procedures were performed using
expired cleansers.
_______________
PRODUCT Red Blood Cells. Recall #B-916-8.
CODE Unit #4772576.
MANUFACTURER National Naval Medical Center, Bethesda, Maryland.
RECALLED BY Manufacturer, by telephone on October 20, 1997,
followed by telephone on November 12 and 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product which may have been contaminated
with Corynebacterium sp., was not quarantined and
was distributed in error after notification of the
positive culture results.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-920-8.
CODE Unit #10531-7126.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on August 10, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of clotted
Red Blood Cells.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-922/923-8.
CODE Unit #22KT08217.
MANUFACTURER American Red Cross Blood Services, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated January 23, 1998.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking
the drug Proscar.
_______________
PRODUCT Whole Blood. Recall #B-924-8.
CODE Unit numbers: 22GY78361 and 22GY78367.
MANUFACTURER American Red Cross Blood Services, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on December 18, 1997,
and by letter dated January 8, 1997. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY 2 units were distributed.
REASON Blood products were collected in a manner that
compromises the sterility of the units.
_______________
PRODUCT Recovered Plasma. Recall #B-927-8.
CODE Unit #22GE41725.
MANUFACTURER American Red Cross Blood Services, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on November 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving
post donation information regarding the safety of
the product.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-930/931-8.
CODE Unit #06LS54153.
MANUFACTURER American Red Cross, Los Angeles, California.
RECALLED BY Manufacturer, by letter dated November 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had
body piercing within 12 months of donation.
_______________
PRODUCT Red Blood Cells. Recall #B-932-8.
CODE Unit numbers: 10529-5688, 10529-5689, 10529-5693,
10529-5691, 10529-5690.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on May 30, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arizona.
QUANTITY 5 units were distributed.
REASON Blood products were tested using samples that may
have been shipped at an unacceptable temperature.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-933-8.
CODE Unit #36294-4718.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on October 28, 1998. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood
Cells that was positive for Streptococcus viridans
and was implicated in a transfusion reaction.
_______________
PRODUCT Red Blood cells. Recall #B-937-8.
CODE Unit #10236-4412.
MANUFACTURER Blood Systems, Inc., Scottsdale, Arizona.
RECALLED BY Manufacturer, by letter dated April 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
traveled to an area considered endemic for
malaria.
_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Cryoprecipitated AHF
d) Recovered Plasma. Recall #B-938/941-8.
CODE Unit numbers: a) 10231-0389, 10219-3504,
10239-0706; b) 10231-0389, 10239-0706
c) 10219-3504; d) 10231-0389, 10219-3504,
10239-0706.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated June 23, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arizona, New York, Massachusetts.
QUANTITY a) 3 units; b) 2 units; c) 1 unit; d) 3 units were
distributed.
REASON Blood products, collected from a donor who
reported a history of hepatitis.
_______________
PRODUCT Source Leukocytes. Recall #B-942-8.
CODE Unit #22KP23433.
MANUFACTURER American Red Cross Blood Services, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on May 14, 1997, and by
letters dated May 21, 1997 and June 20, 1997.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from an unsuitable
donor.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Red Blood
Cells for further manufacture.
Recall #B-943/945-8.
CODE Unit numbers: a) 22GX55050, 22KR26303, 22FT82373;
b) 22FT82373; c) 22FT79686.
MANUFACTURER American Red Cross Blood Services, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated either June 30,
1997, July 25, 1997 or October 3, 1997, and by
telephone on October 1, 1997. Firm-initiated
recall complete.
DISTRIBUTION California, New Jersey, Pennsylvania.
QUANTITY a) 3 units; b) 1 unit; c) 1 unit was distributed.
REASON Blood products were collected from donors who
reported travel to areas designated as endemic for
malaria.
_______________
PRODUCT Red Blood Cells. Recall #B-947-8.
CODE Unit numbers: 49J74053, 49Q55322.
MANUFACTURER American Red Cross Blood Services, Norman,
Oklahoma.
RECALLED BY Manufacturer, by letter dated February 17, 1998.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who
reported living in an area designated as endemic
for malaria.
_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Source Leukocytes; d) Recovered Plasma
e) Platelets, for further manufacturing.
Recall #B-956/960-8.
Unit numbers: a) 1700102, 1702510, 1703905,
1709099, 1710481; b) 1702510; c) 1709099;
d) 1700102, 1702510, 1703905, 1709099
e) 1710481.
MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter dated September 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana, Louisiana, Massachusetts, New Jersey,
Switzerland.
QUANTITY a) 5 units; b) 1 unit; c) 1 unit; d) 4 units; e) 1
unit was distributed.
REASON Blood products tested negative for HCV, but
collected from a donor who initially tested HCV
reactive, was not deferred nor properly reentered.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Whole Blood. Recall #B-928-8.
CODE Unit #22FT84347.
MANUFACTURER American Red Cross Blood Services, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on October 24, 1997,
and by letter dated October 28, 1997.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Autologous blood product tested positive for the
hepatitis B surface antigen (HBsAg), was
distributed contrary to the firms standard
operating procedures.
_______________
PRODUCT Platelets, Pheresis. Recall #B-934-8.
CODE Unit #10579-5219-02.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on January 22, 1998. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was not stored under continuous
agitation.
_______________
PRODUCT Red Blood Cells. Recall #B-935-8.
CODE Unit #10578-7907.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on December 30, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product may have remained at room
temperature for greater than 30 minutes.
_______________
PRODUCT Red Blood Cells. Recall #B-936-8.
CODE Unit #10530-9019.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on June 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for
greater than 30 minutes.
_______________
PRODUCT Platelets. Recall #B-946-8.
CODE Unit #22GK54426.
MANUFACTURER American Red Cross Blood Services, Philadelphia,
Pennsylvania.
RECALLED BY Manufacturer, by telephone on August 27, 1997, and
by letter dated September 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole
blood with an extended collection time.
_______________
UPDATE Recall #B-651-8, Fresh Frozen Plasma, Unit
#4764980, recalled by National Naval Medical
Center, which appeared in the March 11, 1998
Enforcement Report is being recinded. This was
published as Recall #B-515-8, in the April 8,
1998, Enforcement Report.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Medtronic 10F Sherpa Firm Guiding Catheters, used
to provide a pathway through which therapeutic
devices are introduced.
Recall #Z-513-8.
CODE Lot Numbers: 53169, 53191, 53302, 53483, 53489,
53653, 53686, 53763, 53889, 54019, 54028, 54139,
54278, 54304, 54525, 54526, 54612, 54613, 54757,
54853, 54854, 55125, 55126, 55200, 55201, 55234,
55236, 55237, 55321,55322, 55365, 55366, 55510,
55511, 55562, 55563, 55628, 55629, 556693, 55694,
55860, 55861, 55955, 55956, 56103.
MANUFACTURER Medtronic Interventional Vascular (MIV), Inc., Danvers, Massachusetts.
RECALLED BY Manufacturer, by letter dated March 18, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Japan, Netherlands.
QUANTITY 1,178 units were distributed.
REASON Cracking/splitting at secondary curve causing a
piece of catheter to become detached.
_______________
UPDATE Recall #Z-363/366-8, which appeared in the March
11, 1998 Enforcement Report is being updated to
include additional information.
PRODUCT Sportarredo high-pressure and low-pressure lamp
sunbeds:
a) Z-363-8: Maximultysun 1500 (Hyperion 150), a 3
Kalfasun 1500 high-pressure facial lamp, and 17
Kalfasun 610 high-pressure lamp sunbed
b) Z-364-8: Turbo Massage T180, a 2 Kalfasun 1500
high-pressure facial lamp, 8 Kalfasun 1500
high-pressure lamp, and 6 Kalfasun 610
high-pressure lamp sunbed
c) Z-365-8: Turbo Massage T200, a 2 Kalfasun 2510
high-pressure facial lamp, 8 Kalfasun 1510
high-pressure lamp, and 10 Kalfasun 610
high-pressure lamp sunbed
d) Z-366-8: Kombi 1000, a 1 Kalfasun 1500
high-pressure facial lamp, 39 Kalfasun
low-pressure lamp B14 rapid 160 W, and 10 Kalfasun
610 high-pressure lamp sunbed
e) Z-367-8: Tristar 4000 (Orion), a 3 Kalfasun
1500 high-pressure facial lamp sunchair
f) Z-368-8: Compact Mysun 4000 (Alpha), a 3
Kalfasun 1500 high-pressure facial lamp tabletop
solarium
g) Z-369-8: Ringo 900, a 39 Kalfasun low-pressure
lamp B14 rapid 160 W upright sunbooth
CODE: a) serial #M12310, M12311, M12321, M12322, M12323,
M12324, M12325, M12326, M12327, M12328, M12330,
M12331, M12338, M12361, M12367, M12368, M12369,
M12385, M12386, M12387, M12388, M12389, M12395,
M12396, M12397, M12401, M12402, M12403, M12404,
M12406, M12408, M12425
b) serial #T321, T323, T324, T329, T330, T331,
T333, T335, T336, T337, T338, T339, T340, T341,
T342, T343, T348, T349, T350
c) serial #T317, T334
d) serial #KB10025, KB10026, KB10029, KB10031,
KB10032, KB10037, KB10048
e) serial #TR651, TR675, TR676, TR677, TR678
f) serial #C8911, C8912, C8913, C8914, C8915,
C8916, C8940, C8941, C8942, C8943, C8944, C8945,
C8946, C8947
g) serial #RG15163, RG15164, RG15165, RG15179,
RG15220.
MANUFACTURER Sportarredo Spa, Viale Trieste, 121/A (Ing via
Giotto) Portogruaro, 30026, Italy
RECALLED BY Helios Technologies, Inc., North Aurora, Illinois
(distributor), by letter on April 14, 1998.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 32 Maximultysun 1500 (Hyperion 150), 19 Turbo
Massage T180, 2 Turbo Massage T200, 7 Kombi 1000,
5 Tristar 4000 (Orion), 14 Compact Mysun 4000
(Alpha), and 5 Ringo 900 sunlamp products were
distributed, with the firm estimating that all
remain on the market.
REASON Filure to comply with warning label and user
instruction requirements of the sunlamp
performance standard.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Ortho Recombiplastin II with Ortho Recombiplastin
II Diluent, used for performing Prothrombin Time
(PT) test in human plasma:
a) Product Code No. 732820,;
b) Product Code No. 732850.
Recall #Z-510/511-8.
CODE Lot numbers: a) 2RPK101, 2RPK102, 2RPK103,
2RPK105, 2RPK106; b) 2RPK104.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New
Jersey.
RECALLED BY Manufacturer, by customer notification initiated
July 19, 1997. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 828 packaged kits were distributed.
REASON Reconstituted stability was less than labeling
claims.
_______________
PRODUCT Osteonics Omnifit PSL MicroStructured 50 mm O.D.
Acetabular Shell. The product group is a component
in a series of modular acetabular components such
as acetabular bearing inserts, dome or screw hole
plugs and retaining wires. These components are
designed to be used in conjunction with each other
to achieve total reconstructive hip joint
replacement:
a) Model No. 2017-0050, Serial No. NW3125;
b) Model No. 2017-0052, Serial No. PA3006.
Recall #Z-519/520-8.
CODE a) Serial No. NW3125;
b) Serial No. PA3006.
MANUFACTURER Osteonics Corporation, Allendale, New Jersey.
RECALLED BY Manufacturer, by voice mail followed by letter on
September 5, 1997. Firm-initiated recall
complete.
DISTRIBUTION a) New Jersey, Michigan, Utah, Florida,
California, Minnesota, Japan; b) Massachusetts,
Oklahoma, Arkansas, Minnesota, North Carolina,
Wisconsin, New Jersey, California, Missouri,
Indiana, Florida, Maryland, Ohio, Kentucky, New
York, Australia, Singapore, Canada.
QUANTITY a) 23 units; b) 23 units were distributed.
REASON Units of the Acetabular shell are marked and
labeled as having a 50 mm outer diameter when in
fact they have a 52 mm outer diameter, and vice
versa.
_______________
PRODUCT Omega + Plus Lag Screw, used in osteoporotic bone
and revision cases. Recall #Z-521-8.
CODE Catalog #3362-5-125, Lot Code No. BWYDN.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by telephone on April 25, 1997,
followed by letter on May 5, 1997. Firm-initiated
recall complete.
DISTRIBUTION New Jersey and Puerto Rico.
QUANTITY 11 units were distributed.
REASON The lag screw was incorrectly machined, resulting
in a metal burr about three-quarters of the way
down the screw where the inner threads end that
prevents the screws from passing over the
associated guide pin.
_______________
PRODUCT Rheumaton(tm) 2-minute Hemagglutination Slide Test
for the quantitative and qualitative determination
of rheumatoid factor in serum or synovial fluid:
a) Product No. 35D2, Test Kit Size - 20 Tests
b) Product No. 35D4, Test Kit Size - 50 Tests,
c) Product No. 35D6, Test Kit Size - 150 Tests.
Recall #Z-522/524-8.
CODE Lot Numbers: a) 3G7233D; b) 3G7233A and 3G7233E
c) 3G7233 and 3G7233Z.
MANUFACTURER Wampole Laboratories, Cranbury, New Jersey (own
label distributor).
RECALLED BY Carter-Wallace, Inc., Cranbury, New Jersey
(responsible firm), by telephone starting March
21, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Lot # Amount Shipped
5HG1407 116 (150 tests per kit)
5HG1701 428 (150 tests per kit)
5HG1702 325 (20 tests per kit)
5HG3102 429 (20 tests per kit)
5HH0301 299 (50 tests per kit)
5HH0902 406 (50 tests per kit)
5HH1001 110 (foreign consignment)
5HH1002 597 (foreign consignment)
5HH1101 649 (50 tests per kit)
5HH1601 339 (50 tests per kit)
5HH1603 299 (150 tests per kit).
Firm estimates none remain on the market.
REASON Low amboceptor concentrations in the Rheumaton
reagent can result in reduced test sensitivity.
END OF ENFORCEMENT REPORT FOR APRIL 29, 1998.
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