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.
August 6, 1997 97-32
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Sea Legs brand Whole Leg Style Imitation King Crabmeat,
in 5 pound clear plastic bags.
Recall. #F-568-7.
CODE 2 7134.
MANUFACTURER Sugiyo USA, Inc., Anacortes, Washington.
RECALLED BY Manufacturer, by letter on June 2, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Washington state.
QUANTITY 334 30-pound cases were distributed.
REASON Product is contaminated with Listeria monocytogenes.
_______________
PRODUCT Dips, salads, grape leaves and salsa under the Cedar's
label:
1. Original Hommus Tahini
2. Mediterranean Spice Hommus Tahini
3. No Salt Added Hommus Tahini
4. Baba Ghannouj
5. Roasted Baba Ghannouj
6. Garlic & Chive Hommus Tahini
7. Roasted Red Pepper Hommus Tahini
8. Roasted Almond Hommus Tahini
9. Pimento & Olive Hommus Tahini
10. Sundried Tomato & Basil Hommus Tahini
11. Sauteed Onions & Peppers Hommus Tahini
12. Vegetable Hommus Tahini
13. Garlic Lovers Hommus Tahini
14. Beantown Sport Dip
15. Garden Lentil Salad
16. Taboule Salad
17. Grape Leaves Stuffed with White Rice
18. Boston Vegetable Salsa
Dips under the Mr. Hommus label:
19. Original Hommus
20. Salsa Hommus
21. Garlic Hommus
22. Dill Hommus
23. Scallion Hommus
24. Vegetable Hommus
25. Roasted Garlic & Chive Hommus
26. Roasted Red Pepper Hommus
27. 40 (or Magic) Spice Hommus
28. Sun-dried Tomato & Basil Hommus
29. Sport Dip
The following dips under the Vita Heavenly Hommus! label:
30. Original Hommus
31. Dill Hommus
32. Extra Garlic Hommus
33. Vegetable Hommus
34. Roasted Red Pepper Hommus
35. Lemon Dill Hommus
36. Spice Hommus
37. HOT!!! Red Pepper Hommus
38. Tomato & Basil Hommus
39. Bagel with Chives Hommus
40. Bagel Hommus
The following dips and salads under the Sidon label
(distributed in Canada only):
41. Original Hommus Tahini
42. Piment & Olive (Pimento & Olive)
Hommus Tahini
43. Pour Les Amants D'Lail (Garlic Lovers)
Hommus Tahini
44. Vegetable Hommus Tahini
45. Baba Ghannouj
46. Salad de Lentilles Jardiniere (Garden
Lentil Salad)
47. Salade Taboule. Recall #F-569/615-7.
CODE All lots.
MANUFACTURER Cedars Mediterranean Foods, Inc., Plaistow, New
Hampshire.
-2-RECALLED BY Manufacturer, by telephone beginning on June 12,
1997, followed by fax. Firm-initiated recall
ongoing. See Also FDA press release dated June
12, 1997.
DISTRIBUTION Hawaii, New Hampshire, Vermont, Connecticut,
Massachusetts, Maryland, Maine, New York, New
Jersey, Pennsylvania, Rhode Island, Illinois,
North Carolina, South Carolina, Georgia, Virginia,
Michigan, Minnesota, Ohio, Canada.
QUANTITY 1,166,857 units produced between April 1997 to June 12,
1997 (including 8 ounce, 16 ounce, 5 pound).
REASON The products may be contaminated with Listeria
monocytogenes.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma.
Recall B-1079/1082-7.
CODE Unit numbers: KH71577, KH72926, KH74741; b) KH71577; c)
KH71577; (d) KH72926, KH74741.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, telephone and fax on April 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia, Illinois, California, Switzerland.
QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 2 units were
distributed.
REASON Blood products were collected from a donor with a
history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1098/1099-7.
CODE Unit #36FK11300.
MANUFACTURER American Red Cross Blood Services, Columbia, South
Carolina.
RECALLED BY Manufacturer, by letter dated April 11, 1997, and
by fax on April 4, 1997. Firm-initiated recall
complete.
DISTRIBUTION South Carolina and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose spouse
has hepatitis C.
_______________
PRODUCT Fresh Frozen Plasma, Pheresis.
Recall #B-1100-7.
CODE Unit #4020498.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
-3-RECALLED BY Manufacturer, by telephone on January 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with an
elevated body temperature.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-1104-7.
CODE Unit #03GT25232.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on May 16, 1997. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of Red Blood Cells
that was reported as clotted.
_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-1105/1106-7.
CODE Unit #03GP11980.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on June 4, 1997. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were prepared from a unit of Whole Blood
designated as a "difficult collection".
_______________
PRODUCT Platelets. Recall #B-1107-7.
CODE Unit #03FJ41109.
MANUFACTURER American Red Cross Blood Services, Atlanta,
Georgia.
RECALLED BY Manufacturer, by telephone on June 3, 1997. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole Blood
designated as a "difficult collection".
_______________
PRODUCT Platelets. Recall #B-1108-7.
CODE Unit #28GM03018.
MANUFACTURER American Red Cross Blood Services, Savannah,
Georgia.
RECALLED BY Manufacturer, by telephone on or about March 3,
1997. Firm-initiated recall complete.
-4-DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole Blood
designated as a "difficult collection".
_______________
PRODUCT Platelet Pheresis, Split unit.
Recall #B-1109-7.
CODE Unit #21P67362.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated May 20, 1997. Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported
travel to an area designated as endemic for malaria.
_______________
PRODUCT Platelet Pheresis, Irradiated.
Recall #B-1110-7.
CODE Unit #21P67582.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated May 20, 1997. Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported
travel to an area designated as endemic for malaria.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Recovered Plasma.
Recall #B-1112/1115-7.
CODE Unit numbers: a) 4002374, 7108543, 7407945, 7133679,
7332989, 4008031, 1800905, 1820061, 7716673; b) 7108543,
7407945, 4008031, 7716673; c) 7716673; d) 7108543, 7407945,
7133679, 7332989, 4008031, 1800905, 1820061.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letters dated June 5 and 25,
1997, July 9, 1997 or July 15, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, California, Arizona, District of
Columbia.
QUANTITY a) 9 units; b) 4 units; c) 1 unit; d) 7 units were
distributed.
-5-REASON Blood products tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but
were collected from a donor who previously tested
repeatedly reactive for anti-HIV-1, Western blot
negative.
_______________
PRODUCT a) Red Blood Cells; b) Red Blood Cells, for further
manufacture; c) Platelets; d) Platelets, for further
manufacture; e) Fresh Frozen Plasma; f)
Cryoprecipitated AHF; g) Recovered Plasma. Recall #B-1116/1122-7.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance (301) 594-1191 for individual unit
numbers recalled.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by letters dated January 30, 1996,
or July 5, 1996, and on February 1, 1996. Firm-initiated recall complete.
DISTRIBUTION Ohio, Michigan, Kentucky, Georgia, West Virginia,
California, New York, Illinois, Switzerland.
QUANTITY a) 53 units; b) 2 units; c) 20 units; d) 7 units; e) 9
units; f) 10 units; g) 47 units were distributed.
REASON Blood products tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1
(anti-HIV-1), and were subjected to additional
retesting.
_______________
PRODUCT a) Red Blood Cells; b) Red Blood Cells (Irradiated); c)
Platelets; d) Platelets (Irradiated). Recall #B-1130/1133-7.
CODE Unit numbers: a) 1008883; b) 3000751; c) 1008883; d)
3000751.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by letter on February 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported
travel to an area designated as endemic for malaria.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Platelet Pheresis, Leukodepleted.
Recall #B-1066-7.
CODE Unit #40P53940.
-6-MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on May 27, 1997, and by
letter on June 9, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was distributed without
obliteration of U.S. license.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-1070/1072-7.
CODE Unit numbers: a) 5047904; b) 5047904 and 5047905; c) 5047904
and 5047905.
MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on May 27, 1997,
followed by letters dated May 28, 1997 or June 11,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio and Kentucky.
QUANTITY 1) 1 unit; b) 2 units; c) 2 units were distributed.
REASON Blood products were incorrectly tested for the
hepatitis B surface antigen (HBsAg), and a subsequent
donation which tested negative for HBsAg.
_______________
PRODUCT Red Blood Cells. Recall #B-1073-7.
CODE Unit numbers: 30167-6907, 30167-6925, 30167-6939, 30167-6943.
MANUFACTURER United Blood Services, Bismark, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on September 20, 1996. Firm-initiated
recall complete.
DISTRIBUTION South Dakota.
QUANTITY 4 units were distributed.
REASON Unlicensed blood products were distributed labeled with
the firm's license number.
_______________
PRODUCT Red Blood Cells. Recall #B-1076-7.
CODE Unit #9503178.
MANUFACTURER LifeShare Blood Centers, Beaumont, Texas.
RECALLED BY LifeShare Blood Centers, Shreveport, Louisiana, by
telephone on February 13, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after receipt of post
donation cold symptoms.
-7-_______________
PRODUCT Red Blood Cells. Recall #B-1078-7.
CODE Unit #30168-7277.
MANUFACTURER United Blood Services, Bismarck, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on December 23, 1996. Firm-initiated
recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for an
unacceptable length of time.
_______________
PRODUCT Buffy Coat. Recall #B-1083-7.
CODE Unit #KH74741.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on April 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history
of cancer.
_______________
PRODUCT a) Platelets; b) Fresh Frozen Plasma.
Recall #B-1093/1094-7.
CODE Unit #KQ21662.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on or about December
22, 1995. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the
antibiotic Cipro.
_______________
PRODUCT Source Plasma. Recall #B-1096-7.
CODE Unit #G-56799-081.
MANUFACTURER Alpha Therapeutic Corporation, Charlotte, North
Carolina.
RECALLED BY Alpha Therapeutic Corporation, Los Angeles,
California, by letter on September 26, 1996.
Firm-initiated recall complete.
DISTRIBUTION Spain.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for syphilis by RPR.
_______________
PRODUCT Red Blood Cells. Recall #B-1097-7.
CODE Unit #18Q91042.
-8-MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter dated March 7, 1997.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose
screening was inadequately performed.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-1101/1103-7.
CODE Unit #KE53396.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by letter dated December 9, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia and Utah.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the
drug, Mellaril.
_______________
PRODUCT Red Blood Cells. Recall #B-1111-7.
CODE Unit #21GJ79343.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by telephone on May 8, 1997. Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration
date.
_______________
PRODUCT Red Blood Cells. Recall #B-1128-7.
CODE Unit numbers: 16LN06282, 16LR08707, 16LY18116.
MANUFACTURER American National Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by letter on December 10, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio and American Samoa.
QUANTITY 3 units were distributed.
REASON Unit of pooled platelets implicated in a post
transfusion reaction were found to be contaminated with
Proprionibacterium acnes.
_______________
PRODUCT Red Blood Cells Leukodepleted.
Recall #B-1129-7.
CODE Unit #16LS10360.
MANUFACTURER American National Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by letter on October 10, 1996.
Firm-initiated recall complete.
-9-DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Red Blood Cells were leukodepleted by filtration
greater than five days past the time of collection.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Reusable POLYCARBONATE DOMES without Diaphragm, Catalog
No. TA1010"D", used to help measure physiological
pressure by serving as a reservoir for sterile liquid
and converts the incoming pressure into an electrical
output for the monitor. Recall #Z-690-7.
CODE Lot Nos. SD1206, SD1207, SD1223, SD1286, SD1302,
SD1342.
MANUFACTURER Ohmeda (Singapore), Singapore.
RECALLED BY Ohmeda Medical Devices Division, Inc., Murray
Hill, New Jersey, by letter dated January 28,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Florida, Alabama, Washington state, New Jersey,
Illinois, California.
QUANTITY 2,238 pieces were distributed.
REASON The lots incorrectly contain the suffix "D" which
indicates a single use, sterile device, when in fact
they are reusable non-sterile devices.
_______________
PRODUCT ECOSYSTEM Endoscopic Ligation Cartridges, used as a
part of the Weck Hemoclip Ecosystem Ligation System:
a) Catalog No. 140145;
b) Catalog No. 140245; c) Catalog No. 140601;
d) Catalog No. 140603; e) Catalog No. 140604.
Recall #Z-692/696-7.
CODE All Lots.
MANUFACTURER Pilling Weck, Inc., Research Triangle Park, North
Carolina.
RECALLED BY Manufacturer, by letter on May 27, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 48,914 products were distributed.
REASON Products are subject to improper clip closure.
_______________
PRODUCT InstaTrak Systems containing an Electromagnetic
Tracking Device, used for the acute and chronic
sinusitis endoscopic, dacryocystorhinostomy, optic
nerve and orbital decompression, the removal of polyps,
the
-10- biopsy and removal of tumors, and the repair of CSF leaks,
pituitary disorder, and encephalocele:
a) InstaTrak System, Catalog No. IT-100ENT, an Image Guided
Surgery System that employs a computer, software and
electromagnetic tracking device that is used for endoscopic
sinus surgery; b) ConneCTstat Workstation, Catalog No.
CS-100, an independent workstation used to archive CT images
onto a cartridge which maybe used on the InstaTrak System
during surgery. It does not have a position sensing and
tracking capabilities.
Recall #Z-751/752-7.
CODE Serial Nos. a) IT-10012, IT10013, IT10015, IT10016,
IT10020, IT10021, IT10022, IT10024, IT10027, IT10029;
b) CS101, CS102.
MANUFACTURER Visualization Technology, Inc., Woburn,
Massachusetts.
RECALLED BY Manufacturer, by letter June 13, 1997. Firm-initiated recall ongoing.
DISTRIBUTION New York, Tennessee, Minnesota, Ohio, District of
Columbia, Massachusetts, Illinois, Pennsylvania.
QUANTITY (a) 10 units; b) 2 units were distributed.
REASON The firm was found to be not in conformance with the
Good Manufacturing Practice (GMP) for Medical Devices
Regulation, in that it failed to provide adequate
documentation the Electromagnetic Tracking Device (P/N
1000045-001) met the firm's specifications.
_______________
PRODUCT QuickStripe Chlamydia Ag, Catalog No. 1185/0185, a
rapid, visual assay for the detection of Chlamydia
trachomatis antigen in endocervical, urethral, or male
urine specimens. Recall #Z-753-7.
CODE Kit Lot No. 0005-1.
MANUFACTURER Chembio Diagnostics Systems, Inc., Medford, New
York.
RECALLED BY Diatech Diagnostics, Inc., Boston, Massachusetts
(distributor), by letters on May 8, 1997, and June
3, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Russia, Egypt, Miami (Trinidad).
QUANTITY 302 kits (20 tests per kit) were distributed.
REASON The cassette has a shortened "lip" for holding the test
membrane in place, making it difficult to read the
results.
-11-_______________
PRODUCT Revolution Manual Wheelchair.
Recall #Z-768-7.
CODE Various serial numbers.
MANUFACTURER Quickie Designs, Inc., Fresno, California.
RECALLED BY Manufacturer, by letter on June 12, 1997. Firm-initiated recall complete
DISTRIBUTION Nationwide and international.
QUANTITY 2,749 units were distributed.
REASON The Caster Hinge and Bolt may potentially detach
causing the wheelchair to collapse and the user to fall
and be injured.
_______________
PRODUCT Lead Aprons, Vests, Wraps, Thyroid Collars and Gonad
Shields, radiation protective devices:
a) Aprons; b) Apronettes; c) Mini Aprons; d) Apron with
Thyroid Collar; e) Wraps; f) Jackets; g) Vests; h) Skirt; i)
Vest and Skirt; j) Thyroid Collars; k) Gonadal Shields.
Recall #Z-769/779-7.
CODE a) Aprons
E-Z-EM, Inc. Catalog Numbers -- Lot Numbers:
A241 - Lot 132; A25F - Lot: 274;
A25H - Lot: 130, 131; A25K - Lots: 123, 131, 132, 134; A32J
- Lots: 104, 186; A32K - Lot: 104; A32M - Lot: 186; A33F -
Lot: 113; A33H - Lot: 113; A33K - Lot: 93677; A33M -
Lots:113, 284; A33S - Lot: 285; A35F - Lots: 123, 134, 274;
A35G - Lots: 113, 134, 276; A35J - Lots: 113, 123; A35K -
Lots: 102, 113,130, 132, 133, 134, 144; A35L - Lots: 113,
130; A35M - Lots: 113, 130, 284; A35S - Lots: 113, 130 285;
A43H - Lot: 286; A44H - Lot: 112; A44K - Lot: 186; A45K -
Lots: 285, 286; A47G - Lots 102, 113, 123, 131, 165; A47H
- Lots: 102, 113, 116, 126, 285, 132625; A47K - Lots: 111,
113, 123, 126, 130, 131; A77G - Lot: 134; AF32G - Lot: 104;
AF35G - Lots: 102, 104, 113, 116, 123, 126, 236; AF35H -
Lots: 104, 113, 116, 131, 230; AF35J - Lots: 108, 111, 116,
123, 133; AF35K - Lots: 113, 116, 123, 130, 131, 132, 133,
134; AF35L - Lots: 102, 108, 116, 133, 276; AF35M - Lots:
111, 116, 133, 134, 284; AF35S - Lots: 116, 130, 133, AF51K
- Lots: 198, 285; AF52K - Lots: 274, 277; AF52S - Lot: 277;
AF54H - Lot: 134;
AF54K - Lots: 130, 131; AF54M - Lots: 133, 134, 269; AF54S -
Lot: 269; AF55K - 130, 277, AF55S - Lot: 129, AF73S - Lot:
285,
AF75G - Lot: 104, AF75K - Lot: 104,
AF77G - Lots: 102, 123, 129, 165, 285,
-12- AF77H - Lots: 116, 123, 126, 165, 191,
AF77J - Lot: 285, AF77L - Lot: 144,
AF83J - Lot: 123, AF85F, Lot: 113,
AF85G - Lot: 116, AF85H - Lot: 131; AF85J - Lots: 123, 133;
AF85K - Lots: 113, 123, 130, AF85L - Lot: 113; AF85M - Lot:
116; AF85S - Lot: 134; AF85T - Lot: 113; AF95F - Lot: 111,
AF95G - Lots: 111, 129, 276; AF95H - Lots: 102, 116, 130;
AF95K - Lots: 102, 111, 113, 123, 130, 134, 144, 234, 236;
AF95L - Lots: 111, 116, 126, 130, 133, 276; AF95M - Lots:
112, 113, 130 133; AF95S - 116, 130, 133, 134, 135,
A900 - Lots: 113, 116, 133, 134, 144.
Picker Sentry Lite, Catalog Numbers, Lot Numbers:
253176 - Lots: 113, 116,133, 134, 274;
253177 - Lots: 102, 111, 113, 116, 129, 130, 131, 134,
274; 253178 - Lots: 108, 116, 130, 274; 253179 - Lot: 274;
253180 - Lots: 113, 116, 129, 131, 134; 253181 - Lots:
113, 123, 131, 144; 253369 - Lots: 116, 131, 132, 134, 138,
165, 276, 288; 253370 - lots: 113, 116, 123, 134, 276, 288;
253371 - Lots: 113, 116, 123, 129, 131, 276, 288; 253376 -
Lots: 133, 134; 253377 - Lots: 130, 133, 134; 253378 -
Lots: 131; 253379 - Lots: 131, 134; 256008 -Lots: 130, 136;
256009 - Lots: 131, 177; 256223 - Lots: 131, 133; 256227 -
Lots: 116, 131, 134; 256228 - Lots: 113, 116, 276; 256229
- Lots: 133, 276; 256233 - Lot: 961091; 256236 - Lot: 116;
256237 - Lots: 116, 129, 130, 131, 133, 134; 256238 - Lots:
111, 113, 131, 132, 134, 165; 256239 - Lots: 131, 132, 133;
256253 - Lots: 134, 274, 276; 256254 - Lots: 134, 234;
256255 - lots: 113, 116, 130, 134, 276; 256258 - Lots: 111,
116, 134; 256259 - Lots: 111, 133, 234, 288; 256260 - Lots:
111, 113, 116, 129, 130, 133, 134, 276, 286; 256261 - Lots:
113, 133, 276, 280, 286;
257882 - Lots: 108, 129, 133, 276; 258042 - Lot: 286;
258043 - Lots: 104, 116, 165, 280;
258078 - Lots: 130, 134, 286; 258080 - Lots: 113, 129, 130,
133, 288; 258200 - Lots: 116, 126; 258889 - Lot: 116;
258891 - Lots: 104, 108; 258892 - Lot: 133; 258894 - Lots:
104, 131; 258895 - Lots: 104, 108, 113, 116, 123, 130, 134;
258896 - Lots: 104, 108, 116, 126, 130; 258897 - Lots: 108,
113, 134, 276; 259249 - Lot: 144; 261871 - Lot: 286; 261872
- Lot: 274; 261876 - Lot: 144; 261885 - Lot: 134;
263694 - Lots: 126, 129, 131, 133;
-13- 263695 - Lots: 113, 129, 132, 133;
264622 - Lots: 134, 284; 264624 - Lot: 105;
264625 - Lots: 111, 116, 131, 133, 223, 234, 284, 286;
264626 - Lots: 102, 130, 276;
264627 - Lots: 131, 165, 236;
264628 - Lots: 111, 131, 234;
264629 - Lots: 113, 144
264630 - Lots: 129, 130, 134, 165
264631 - Lot: 276; 264632 - Lot: 131
264633 - Lots: 113, 144
264634 - Lots: 105, 113, 116, 129, 276
264635 - Lots: 130, 276
264636 - Lots: 113, 116, 129, 131, 133, 276
264637 - Lots: 129, 133, 134, 274, 276, 286
264638 - Lots: 113, 116, 129, 276
264639 - Lots: 131, 136, 276, 286
264709 - Lot: 136; 265287 - Lots: 113, 133
265288 - Lots: 129, 276; 265289 - Lots: 133, 276; 265492 -
Lots: 116, 131, 276
265493 - Lot: 129; 265494 - Lot: 134
265495 - Lots: 136, 138, 190
265496 - Lots: 136, 177l; 265497 - Lots: 136,
138; 265513 - Lots: 104, 105, 108, 116, 126, 130, 131, 134;
136, 190, 223, 234, 276
265579 - Lots: 140, 190; 266191 - Lot: 116
266192 - Lot: 134; 266193 - Lot: 134
266194 - Lot: 131; 266195 - Lot: 104
266197 - Lot: 116, 131, 165
266198 - Lot: 136; 266228 - Lot: 116, 123, 236
266229 - Lot: 113, 134, 62694
266230 - Lot: 131; 266231 - Lots: 104, 126, 137; 266232 -
Lots: 108, 116
266233 - Lots: 108, 144
266236 - Lots: 144, 165, 236
266238 - Lot: 104; 266239 - Lot: 234
266240 - Lot: 126; 266241 - Lot: 294
266245 - Lots: 144, 223, 234
266246 - Lot: 126; 266305 - Lot: 105
269682 - Lot: 104; 269683 - Lots: 104, 111, 113, 129, 130,
133, 234, 276
269684 - Lots: 111, 113, 116, 130, 131, 133, 134, 235, 284,
286, 294
269685 - Lots: 104, 111, 113, 129, 130, 234
269686 - Lots: 111, 131, 234, 276
269687 - Lots: 104, 111, 113,116, 130, 131, 234, 276, 284
269688 - Lots: 116, 130, 133, 134, 234, 276
269689 - Lots: 104, 111, 113, 116, 130, 131, 134, 223, 234,
223, 276, 284, 286
269690 - Lots: 136, 190
400802 - Lots: 102
400803 - Lots: 102, 113, 234
-14- 400804 - Lots: 130, 234
400805 - Lots: 286; 264625T - Lot: 144
264626T - Lot: 144; 264628T - Lots: 144, 223
264634T - Lots: 105, 126
264635T - Lots: 105, 126; 264636T - Lot: 126
264637T - Lot: 126, 144;
264638T - Lots: 104, 236; 264639T - Lot: 102
265287T - Lots: 108, 126; 265289T - Lot: 126
265493T - Lot: 126; 265497T - Lots: 190, 191
266195T - Lot: 104; 266197T, Lot: 104, 126
269683T - Lots: 105, 126, 144
269684T - Lots: 102, 108, 126, 144, 236
269685T - Lots: 108, 144, 236, 260
269686T - Lots: 104, 126, 144, 223
269687T - Lots: 126, 144, 223, 236
269688T - Lots: 104, 260
269689T - Lots: 104,108, 126, 223, 260, 276
269690T - Lot: 190; 9EZM79J - Lot: 116
9EZM79K - Lots: 113, 130, 131, 132, 133, 280
9EZM79L - Lots: 116, 134
9EZM79S - Lots: 116, 284; EC94 - Lot: 133
b) Apronettes
E-Z-EM Catalog Numbers - Lot Numbers:
A15A - Lots: 113, 133, 134
A15B - Lots: 113, 133, 134, 286
A15C - Lots: 123, 130, 134
A15D - Lots: 113, 116, 130, 134, 286
A15E - Lots: 113, 116, 123, 130, 132, 133, 230, 274
c) Mini Aprons
Picker Catalog Numbers - Lot Numbers:
258162 - Lots: 113, 116, 129, 131, 132, 133, 134, 288
258163 - Lots: 113, 116,129, 130, 131, 132, 133, 134, 223,
280, 286, 288
258164 - Lots: 113, 116, 123, 129, 130, 131, 132, 133, 223,
277, 286, 288
258165 - Lots: 113, 116, 123, 129, 132, 133, 134, 288;
259356 - Lots: 113, 130
d) Apron with Thyroid Collar
Picker Catalog Numbers - Lot Numbers:
253372 - Lot: 130; 253373, Lot: 134
256017 - Lots: 116, 276
256018 - Lots: 113, 116, 130, 133, 286
256019 - Lots: 116, 130, 134, 280, 286
256020 - Lots: 116, 133
256021 - Lots: 116, 131, 133
256022 - Lots: 131,133
265514 - Lots: 165, 177
265515 - Lots: 104, 126, 236
266247 - Lots: 104,126,144, 165, 236
266248 - Lot: 236; 266249 - Lot: 105
-15- e) Wraps
E-Z-EM Catalog Numbers - Lot Numbers:
AFS7L - Lots: 134, 274, 091594
AFS7M - Lots: 126, 134
AS7L - Lot: 134; AS7M - Lots: 116, 134
Picker Catalog Numbers - Lot Numbers:
256241 - Lot: 129; 256242 - Lot: 131
256243 - Lot: 134; 256246 - Lot: 130
265501 - Lot: 104, 113,127, 130, 134, 165, 223
265503 - Lot: 92877
265504 - Lots: 104, 105, 126, 127, 129, 134, 144, 165, 223,
233, 236, 274
265505 - Lots: 105, 108, 111, 116, 127, 134
265506 - Lots: 129, 144
265510 - Lots: 102, 104, 116, 123, 126, 127, 134, 136, 144,
165, 223, 236
265511 - Lots: 104, 123, 165
265512 - Lots: 144, 236
265517 - Lots: 126, 131
265727 - Lots: 123, 134, 223
265729 - Lots: 116, 123
266203 - Lot: 104
266204 - Lot: 129
266205 - Lots: 108, 116, 234
266206 - Lot: 116
f) Jackets
Picker Catalog Numbers - Lot Numbers:
264640 - Lots: 104, 105, 108, 113, 116, 130, 134, 165, 223,
236, 276
264641 - Lot: 111; 264642 - Lot: 289
264643 - Lots: 104, 105, 126, 134, 165, 223, 233, 236
264644 - Lots: 104, 105, 108, 116, 126, 134, 223; 264645 -
Lot: 144
264649 - Lots: 104, 111, 116, 126, 127, 133, 136, 144, 223,
236
264650 - Lots: 104,123, 165
264651 - Lots: 123, 144, 236
265498 - Lots: 123, 129, 134, 144,223, 234
265516 - Lots: 108, 126, 144, 165, 236
266199 - Lots: 104, 081095
266200 - Lots: 129, 234
266201 - Lots: 108, 116
266202 - Lot: 165
g) Vests
E-Z-EM Catalog Numbers - Lot Numbers:
AFV7L - Lot: 134
AFV7M - Lots: 126, 134
AFV7S - Lot: 123; AV7L, Lot: 134
AV7M - Lots: 116, 134
Picker Catalog Numbers - Lot Numbers:
266526 - Lot: 104; 266527 - Lot: 104
-16- 266528 - Lots: 108, 130
266529 - Lots: 108, 111
266530 - Lot: 108; 266532 - Lot: 102
266542 - Lot 108; 266543 - Lot 108
266550 - Lot 130
253369V - Lots: 113, 129, 131, 276
253370V - Lots: 113, 123, 129, 131, 134
253371V - Lots: 129, 131, 133, 134, 276
h) Skirt
Picker Catalog Numbers - Lot Numbers:
266535 - Lots: 104, 130
266536 - Lots: 102, 108
266537 - Lot: 108; 266538, Lot: 108
266540 - Lot: 111; 266547, Lot: 108
266549 - Lot: 102; 266551 - Lot: 144
I) Vest and Skirt
Picker Catalog Numbers - Lot Numbers:
256247 - Lots: 104, 116, 133, 134
256248 - Lots: 102, 104, 116, 129, 133, 134
256249 - Lots: 102, 108
256251 - Lot: 116
256252 - Lots: 130, 131, 133
257896 - Lots: 104, 108, 144
261953 - Lots: 135, 144
261954 - Lots: 123
j) Thyroid Collars
E-Z-M Catalog Numbers - Lot Numbers:
A656; 5x25 - Lots: 102, 113, 116, 123, 129, 130, 131, 132,
133, 134, 144, 165, 236, 274, 276, 277, 284, 285, 286,
294, 89993
Picker Catalog Numbers - Lot Numbers:
254179 - Lots: 104, 113, 116,, 123, 129, 130, 131, 132,
133, 134, 140, 246, 274, 276, 284, 286, 288
254180 - Lots: 113, 116, 129, 130, 133, 134, 276, 286
258419 - Lots: 108, 113, 116, 123, 129, 130, 131, 133, 134,
223, 276, 280, 284, 286
264736 - Lot: 280
265544 - Lots: 113, 116, 123, 126, 129, 130, 131, 133, 236,
276, 280, 284
265545 - Lots: 113, 116, 123, 129, 130, 131, 133, 144, 234,
276
265546 - Lots: 113, 116, 125, 129, 131, 239, 269
266207, Lots: 116, 123, 130, 131, 134, 144, 165
k) Gonadal Shields
Picker Catalog Numbers, Lot Numbers:
254178 - Lots: 110, 113, 116, 117, 118, 119, 128, 129, 131,
133, 136, 144, 145, 168, 169, 180, 181, 191, 197, 198, 199,
202, 206, 207,
-17- 210, 213, 216, 224, 230, 236, 237, 246, 269, 277, 285, 286,
1144, 8293, 8693, 8994, 9213, 9393, 10496, 62094, 62294,
91594, 92093, 92194, 92328, 92329, 92334, 92339, 92387,
92430, 92436, 92437, 92438, 92549, 92663, 92772, 92872,
93221, 933326, 93328, 93343, 93443, 93449, 93450, 93671,
93673, 95449, 101493, 101493, 121693, 921197, 1074205,
1075215, 1076233, 1077258, 1079266, 1081300, 1132967,
9112344, 9211105, 9211106, 9212107, 9212108, 9212109,
11381011, 11381014, 11381020, 11431069, 011094, 92-10-94,
92-11-97, 98-11-97
262004 - Lots: 113, 116, 117, 119, 128, 129, 131, 132, 133,
135, 141, 144, 162, 168, 179, 180, 183, 191, 197, 198, 202,
207, 210, 213, 224, 236, 248, 269, 285, 286, 8994, 9213,
11294, 92194, 92436, 92549, 92664, 92668, 92772, 92872,
92876, 93443, 93892, 1075213, 1076213, 1132971, 1137999,
11381020, 011094.
MANUFACTURER E-Z-EM, Inc., Westbury, New York.
RECALLED BY Manufacturer, by letters on June 6, 9, 20, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY E-Z-EM & Picker Int'l labeled Aprons, Vests, and Wraps:
a total of 2270 units (domestic & foreign combined)
E-Z-EM labeled Thyroid Collars: 560 units
Picker International Thyroid collars: 1014 units (930
domestically, 84 foreign)
Picker International Gonad Shields: 694 units (681
domestically, 13 foreign).
REASON The radiation protection devices contain lead
contaminated with small amounts of radioactive
substances.
_______________
PRODUCT Pilling Weck Manual Endoscopic Hemoclip Applier,
Catalog #113511, for use in endoscopic application of
Pilling Weck Hemoclips. Recall #Z-795-7.
CODE All lot numbers.
MANUFACTURER Hauser Medizintechnik, Gosheim, Germany (units
date stamped 1/96 - 1/97); Edlo, SA Productos
Medicos, Canoas, Brazil (units marked "Brazil").
RECALLED BY Pilling Weck, Inc., (now Weck Closure Systems),
Research Triangle Park, North Carolina, by letters
on December 20, 1996, and May 7, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Mexico, Brazil, Peru, Puerto Rico,
Canada, Argentina.
-18-QUANTITY 1,034 products were distributed.
REASON The luer lock can become loose and/or the rotation knob
may experience cracking which could affect the intended
function of the applier.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT STA-PTT-LT(5) Catalog No. 00668. The kit provides
reagent for the determination of the activated partial
thromboplastin time (APPT) which is used as a general
coagulation screening test. Recall #Z-743-7.
CODE Lot Nos. 951178, 951300, 962051, 962681, 963101, and
963382.
MANUFACTURER Diagnostica Stago, Franconville, France.
RECALLED BY American Bioproducts Company, Parsippany, New
Jersey,, by letter sent on February 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY LOT # AMT SHIPPED (BOXES)
951178 740
951300 235
962051 293
962681 96
963101 23
963382 51.
REASON Product is contaminated by Penicillium.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I ===========
_______________
PRODUCT Purina Sweetina Horse Feed (nonmedicated), in 50
pound bags. Recall #V-037-7.
CODE Lot #3525.
MANUFACTURER Purina Mills, Inc., Macon, Georgia.
RECALLED BY Manufacturer, by telephone on February 10,
1997. Firm-initiated recall complete.
DISTRIBUTION Georgia and Alabama.
QUANTITY 113 bags were distributed.
REASON Feed was likely contaminated with medicated feedlot
feed containing monensin and tylosin.
MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Datascope-Cardiac Assist Insertion Kits for use
with Datascope Intra-Aortic Balloons and Datascope-Cardiac Assist Introducer Single Pack Kits for use
with Datascope Inra-Aortic Balloons. Safety
Alert #N-016/027-7.
-19-CODE 1. Model No. 0684-00-0187-01, Lot No. UN;
2. Model No. 0684-00-0257, Lot Nos. TZ, UO;
3. Model No. 0684-00-0264, Lot Nos. UF, UC, TW, VE, VF,
VW, VZ;
4. Model No. 0784-00-0114, Lot Number None indicated;
5. Model No. 0784-00-0125, Lot Nos. VG, VP;
6. Model No. 0684-00-0251-11, Lot Nos. UE, UD, UJ,
UL,VS, VY;
7. Model No. 0784-00-0103-04, Lot No. UA;
8. Model No. 0784-00-0128, Lot Nos. VA, VN;
9. Model No. 0684-00-251-13, Lot Nos. QU, UH, UG, UB,
TY, TX, TU, UI, UP, VC, VD, VI;
10. Model No. 0784-00-0129, Lot Nos. VB, VQ;
11. Model No. 0784-00-0103-13, Lot No. UM;
12. Model No. 0684-00-0208, Lot No. UQ.
MANUFACTURER Datascope, Cardiac Assist Division, Fairfield,
New Jersey.
Alerted By Manufacturer, by letters on September 27,
1996, October 2 and 3, 1996.
DISTRIBUTION Nationwide and international.
QUANTITY 27,856 units were distributed.
REASON The inadvertent removal of the hemostasis valve
which may lead to the unanticipated blood loss to
the patient. Notification also included
instructions regarding use of subject device, and
how to minimize bleeding if hemostasis valve is
removed.
END OF ENFORCEMENT REPORT FOR AUGUST 6, 1997. BLANK PAGES MAY FOLLOW.
-20-
####
End of Enforcement Report for
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