CODE
None. The recalled product represented invoiced shipments from
5/28/98 to 6/4/98.
MANUFACTURER
C.I. Oceanos S.A.. Colombia.
RECALLED BY
Interamerican Trading and Products Corporation, Medley
(repacker/distributor), by letter on July 29, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION
Florida, Ohio, Georgia, Pennsylvania, Alabama, North Carolina,
South Carolina, Maryland, Wisconsin.
QUANTITY
782 10-pound cases were distributed.
REASON
Product may Be Contaminated with Salmonella.
F-617-8 Group 1: Autumn Honey Wheat (Item No. 209), Autumn Honey Wheat 32 oz. (Item No. 210), and Shurfresh 20 oz. Wheat(Item No. 1095). F-618-8 Group 2: Golden Soft 16 oz.(Item No. 215) and F-O-RGoldW (Item No. 984). F-619-8 Group 3: Cot Autumn Grain 100% (Item No. 212). F-620-8 Group 4: GH Stone Ground White (Item No. 204). F-621-8 Group 5: Buttermilk (Item No. 225). F-622-8 Group 6: Holsum Sm A (Item No. 102), Wonder White 16 oz. A (Item No. 103), Blue Seal A (Item No. 947), Great Value 16 oz.(Item No. 1000), and Price Saver 16 oz. A (Item No. 1070). F-623-8 Group 7: Holsum Thin 20 oz. A (Item No. 108), Holsum Twin 40 oz. A (Item No. 113), Holsum Extra Thin A (Item No. 120), Wonder White 24 oz. A (Item No. 130), Big Value 20 SD (Item No. 944), Butterkrust 20 SD (Item No. 953), F-O-R 20 Sandwich (Item No. 985), Great Value 24 oz. A (Item No. 1002), Best Yet 20SD (Item No. 1016), IGA 20 SD (Item No. 1026), Oven Gold 20 SD (Item No. 1045), Piggly Wiggly 20 SD (Item No. 1055), Real Value 20 SD (Item No. 1073), Sally Sandwich 20 oz.(Item No. 1086), Shur Fresh 20 TS A (Item No. 1088), Super Value 20 SD (Item No. 2806), and Parade T Sand White (Item No. 2850). F-624-8 Group 8: HP Buttertop Wheat (Item No. 213), Albertson BT Wheat (Item No. 904), Cof Split Wheat (Item No. 920), Country Market Split (Item No. 963), Great Value Split Wheat (Item No. 1009), Piggly Wiggly Splittop Wheat (Item No. 1054), Price Low Wheat (Item No. 1067), and Parade Wheat OT (Item No. 2854). F-625-8 Group 9: Wonder 24 oz. Family Wheat (Item No. 219), Albertson Lee Wheat 24 oz.(Item No. 909), Goodday Wheat (Item No. 911), and Great Value Wheat 24 oz. (Item No. 1006). F-626-8 Group 10: Wonder OT White A (Item No. 121) and Holsum Large 24 oz. A (Item No. 122). F-627-8 Group 11: HP Buttertop White (Item No. 218). F-628-8 Group 12: HP Butter Wheat 24 (Item No. 216).
CODE
See item numbers listed above. All bread produced at the
Alexandria bakery involved in the product recall would have a
white twist tie on each bag with the number 47 printed on it.
MANUFACTURER
Interstate Brands Corporation, doing business as Cotton's Holsum
Bakery, Alexandria, Louisiana.
RECALLED BY
Manufacturer, by letter dated July 31, 1998., Firm-initiated
recall complete.
DISTRIBUTION
Arkansas, Louisiana, Mississippi, Texas.
QUANTITY
103,590 loaves were distributed.
REASON
Products may have contained pieces of metal.
PRODUCT
Mae Tu brand Shrimp Paste, in 3.5 ounce plastic jars.
Recall #F-632-8.
CODE
None.
MANUFACTURER
Mae Tu Company, Ltd., Bangkok, Thailand.
RECALLED BY
Summit Import Corporation, New York, New York, by letter dated
September 5, 1997. Completed recall resulted from sample
analysis and follow-up by the New York State Department of
Agriculture and Markets.
DISTRIBUTION
Florida, Maryland, Pennsylvania, New York.
QUANTITY
Undetermined.
REASON
Product was contaminated with filth.
PRODUCT
Blue Ribbon Brand "Nova Salmon Bits" (Hickory Smoked) in Rigid
Plastic Tubs with Lids, Net Wt. 8 oz. (227g). Recall
#F-649-8.
CODE
11/30/97.
MANUFACTURER
Blue Ribbon Smoked Fish Co., Inc., Brooklyn, New York.
RECALLED BY
Manufacturer, by telephone on November 25, 1997. Completed
recall resulted from sample analysis and follow-up by the New
York Department of Agriculture and Markets.
DISTRIBUTION
New Jersey and New York.
QUANTITY
21 units were distributed.
REASON
Product contains undeclared nitrites.
CODE
S:Lots 17775 and 17776 of 60-tablet bottles; and lot 17790 of
unit dose packets.
MANUFACTURER
Upsher-Smith Laboratories, Inc., Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by telephone beginning on August 21, 1998, and by
letter dated August 25, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
27,062 60-tablet bottles and 1,240 unit dose, 100-tablet cartons
were distributed.
REASON
Superpotency.
PRODUCT
Fluoride Toothpaste/gel (Colgate/Aim), Regular/Winterfresh/Mint
Flavors, OTC, in 75 ml (3.7 ounce) and 100 ml tubes, product of
Canada. Recall #D-241-8.
CODE
All lots.
MANUFACTURER
Spain's Gifts & Cards, Philadelphia, Pennsylvania.
RECALLED BY
Manufacturer, by fax on or about July 17, 1998. Firm-initiated
recall ongoing.
DISTRIBUTION
Pennsylvania, Delaware, Maryland, New Jersey.
QUANTITY
Undetermined.
REASON
Product may contain cyclamates.
CODE
Lot numbers: 00447F EXP 4/99, 02818F EXP 1/00, 00367F EXP 7/99,
02887F EXP 7/99.
MANUFACTURER
Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY
Parke-Davis, Division of Warner Lambert Company, Morris Plains,
New Jersey, by letter on August 12, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
95,658 units were distributed.
REASON
In-process blend specification failure; loss on drying.
CODE
Unit numbers: a) X68040, X69364, M24522, X71255, X72786, M30179,
M30857, X85826; b) X69364, X72786, M30179; c) X68040;
d) X68040, X69364.
MANUFACTURER
Central California Blood Center, Fresno, California.
RECALLED BY
Manufacturer, by letter dated either December 18 or 20, 1995.
Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
a) 8 units; b) 3 units; c) 1 unit; d) 2 units were
distributed.
REASON
Blood products tested non-reactive for the antibody to the
Hepatitis B core antigen (anti-HBc), but were collected from a
donor who was previously repeatedly reactive for anti-HBc on two
separate donations.
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall
#B-1593/1594-8.
CODE
Unit #47G94206.
MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY
Manufacturer, by letter dated May 12, 1998, by telephone on June
2 and 12, 1998. Firm-initiated recall complete.
DISTRIBUTION
Illinois and California.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products tested negative for the Hepatitis B Surface
Antigen, (HBsAg), but were collected from a
donor who previously tested repeat reactive for HBsAg,
with no confirmatory testing.
CODE
Unit #4113263.
MANUFACTURER
Department of the Navy, Naval Hospital, Bremerton, Washington.
RECALLED BY
Manufacturer, by letters dated December 4 and 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION
California, Florida, Washington state.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who exceeded the
donation acceptance criteria for body temperature.
PRODUCT
Source Plasma. Recall #B-1591-8.
CODE
XU44955, XU45572, XU50832, XU56257, XY04174.
MANUFACTURER
Plasma Center - Tyler, Inc., Austin, Texas.
RECALLED BY
Community Bio-Resources, Inc., Hoover, Alabama, by fax dated
March 18 and 27, 1998. Firm-initiated recall complete.
DISTRIBUTION
Austria.
QUANTITY
5 units were distributed.
REASON
Blood products were collected from donors who were not tested for
syphilis.
PRODUCT
Red Blood Cells. Recall #B-1596-8.
CODE
Unit #12430-2715.
MANUFACTURER
United Blood Services, Albuquerque, New Mexico.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on May 18,
1998. Firm-initiated recall complete.
DISTRIBUTION
Colorado.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
PRODUCT
a) RAD-Sure Blood Irradiation Labels, 15GY
b) RAD-Sure Blood Irradiation Labels, 25GY, distributed by ISP,
Huntsville, Huntsville, Alabama. Recall #B-1597/1598.
CODE
a) All identification codes beginning with the following lot
numbers: F40___, F47___, F48___, F50___.
b) All identification codes beginning with the following lot
numbers: F44___, F45___, F46___, F49___, F51A36, F51B44.
MANUFACTURER
KAPCO, Kent, Ohio.
RECALLED BY
International Specialty Products, Wayne, New Jersey, by letter
dated January 12, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
14,508 boxes (200 units per box)of indicators were
distributed.
REASON
Blood irradiation labels may not perform as intended throughout
their labeled expiration dates.
a) Product No. 2051-2048; b) Product No. 2051-2052; c) Product No. 2051-2056; d) Product No. 2051-2060; e) Product No. 2051-3052; f) Product No. 2051-3056; g) Product No. 2051-3060; h) Product No. 2051-2044P; i) Product No. 2051-2066P; j) Product No. 2051-2068P; k) Product No. 2051-2070P; l) Product No. 2051-2072P. Recall #Z-851/862-8.
CODE
Lot numbers: a) Nos. 28026701, 28128401 b) 28077703, 28353902, 28353903 c) 28335401, 28335402, 28355001, 28355002, 28159101, d) 27617807, 28198201; e) 27987801, 28221701; f) 28221901; g) 28159201; h) 28476201; i) 28477601 j) 28477801; k) 28478001; l) 28478101.
MANUFACTURER
Osteonics Corporation, Allendale, New Jersey.
RECALLED BY
Manufacturer, by telephone, followed by letter on August 22,
1997. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and international.
QUANTITY
162 units were distributed.
REASON
The multilingual side of the outer carton has incorrect size
information, while the English side of the outer carton has the
correct size information.
PRODUCT
Horizon Pump IV Administration Set. Recall #Z-869-8.
CODE
LOT# CATALOG# F8C393 NF3116 F8C404 V7410 F8C405 V7410 F8C406 V7410 F8C407 NF3140 F8C494 V7410 F8C495 CC3131 F8C496 NF3160 F8C497 NF3141 F8C498 V7430 F8C499 V7410 F8C500 CC3130 F8C501 NF3150 F8C503 NF3140 F8C504 V7410-SPO2 F8C508 CC3120 F8C509 NF3121 F8C540 V7460 F8C617 V7410 F8C619 NF3140 F8C622 V7425 F8C624 NF3140-10 F8C625 V7410 F8C626 V7490 F8C627 NF3120 F8D040 V7421 F8D087 V7410 F8D089 CC3130 F8D090 CC3130-SPO1 F8D091 NF3140 F8D099 CC3150 F8D124 V7423 F8D220 V7410-10 F8D222 V7413 F8D223 NF3140 F8D224 CC3130-SPO1 F8D225 V7425 F8D226 V7410 F8D227 CC3130 F8D228 CC3131 F8D349 V7410 F8D350 V7413 F8D351 V7425 F8D352 NF3140 F8D353 V7410 F8D355 V7490 F8D467 NF3141 F8D468 V7430 F8D469 V7410 F8D470 CC3130 F8D471 NF3140 F8D473 CC3131 F8D474 CC3130-SPO1 F8D475 V7410 F8D476 NF3120 F8D477 V7490 F8E123 V7425 F8E126 V7410 F8E128 CC3130 F8E145 V7460 F8E282 NF3116.
MANUFACTURER
B. Braun Medical, Inc., Bethlehem, Pennsylvania.
RECALLED BY
B. Braun/McGaw, Sabana Grande, Puerto Rico, by letters on May 19,
1998, and July 6, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
560,642 units were distributed.
REASON
Non-conforming Horizon IV Sets due to a defective component
(cassette) assembled into the IV line.
PRODUCT
Biopak for Windows Software, Versions 1.33 and 1.5, for the
BioPak Measurement System, designed to help the physician obtain
a comprehensive evaluation of the entire oral system.
Recall #Z-870/871-8.
CODE
Software Version 1.33 and 1.5 are being replaced.
MANUFACTURER
Bio-Research, Inc., Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by letter on September 24, 1998. Firm-initiated
field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
280 software disk sets (7 disks per set) were distributed.
REASON
The firm did not get premarket approval (PMA) or 510(k) clearance
for significant changes to their BioPak Occlusal Measurement
System.
PRODUCT
Baxter Minicap Disconnect Cap with Povidone-Iodine Solution,
Catalog number 5C4466P, a plastic cap containing povidone-iodine,
designed to isolate the Easy-Lock connector of the solution
transfer set during peritoneal dialysis. Recall #Z-876-8.
CODE
Lot number GD630590.
MANUFACTURER
Baxter Healthcare Corporation, Cleveland, Mississippi.
RECALLED BY
Baxter Healthcare Corporation, McGaw Park, Illinois, by letter
dated September 16, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
207,940 units were distributed.
REASON
Some of the caps do not contain povidone iodine. Use of the caps
with no povidone iodine poses a risk of peritonitis.
PRODUCT
Alcon Surgical Custom Paks containing Devon Needle Counters.
Recall #Z-877/957-8.
CODE
1. Catalog No. 2028-09, Lot Nos. WB76149, WB78362; 2. Catalog No. 3010-08, Lot Nos. WB75782, WB78115; 3. Catalog No. 3073-09, Lot Nos. WB77182, WB79509; 4. Catalog No. 3282-03, Lot Nos. WB79840, WB81469; 5. Catalog No. 3381-09, Lot No. WB75406; 6. Catalog No. 3542-12, Lot Nos. WB73914, WB75299, WB77222, WB78583, WB79534; 7. Catalog No. 3825-12, Lot No. WB75813; 8. Catalog No. 3911-09, Lot No. WB78040; 9. Catalog No. 3972-05, Lot No. WB77135; 10. Catalog No. 4073-08, Lot Nos. WB76413, WB80829; 11. Catalog No. 4075-12, Lot Nos. WB77140, WB82392; 12. Catalog No. 4081-02, Lot No. WB78047; 13. Catalog No. 4188-17, Lot No. WB78053; 14. Catalog No. 4212-08, Lot No. WB79726; 15. Catalog No. 4287-04, Lot Nos. WB76188, WB77898; 16. Catalog No. 4388-04, Lot Nos. WB78628, WB79620; 17. Catalog No. 4389-11, Lot Nos. WB75562, WB79989; 18. Catalog No. 4473-03, Lot Nos. WB75435, WB81017; 19. Catalog No. 4652-04, Lot Nos. WB77165, WB79998; 20. Catalog No. 4654-05, Lot Nos. WB76874, WB79751, WB78400; 21. Catalog No. 4654-06, Lot No. WB81980; 22. Catalog No. 4894-06, Lot Nos. WB76887, WB81244; 23. Catalog No. 4893-08, Lot Nos. WB76212, WB77922; 24. Catalog No. 4893-09, Lot No. WB79768; 25. Catalog No. 4934-03, Lot No. WB76216; 26. Catalog No. 4973-04, Lot Nos. WB68067, WB72101, WB75888, WB81332, WB83302, WB85694; 27. Catalog No. 4893-09, Lot No. WB79768; 28. Catalog No. 5094-12, Lot Nos. WB77350, WB79673; 29. Catalog No. 5100-05, Lot Nos. WB78655, WB79627; 30. Catalog No. 5101-04, Lot No. WB78656; 31. Catalog No. 5180-03, Lot No. WB81335; 32. Catalog No. 5250-06, Lot Nos. WB73979, WB75898, WB82383; 33. Catalog No. 5251-11, Lot Nos. WB68793, WB71818, WB73980, WB77357, WB79713, WB82384, WB84403, WB86116; 34. Catalog No. 5294-08, Lot Nos. WB71896, WB73394, WB74839; 35. Catalog No. 5252-09, Lot No. WB71258; 36. Catalog No. 5402-13, Lot No. WB78120; 37. Catalog No. 5415-03, Lot Nos. WB68507, WB69799, WB71113; 38. Catalog No. 5573-01, Lot Nos. WB76920, WB79843; 39. Catalog No. 5551-06, Lot No. WB78668; 40. Catalog No. 5631-04, Lot No. WB78127; 41. Catalog No. 5663-05, Lot Nos. WB78917, WB80878; 42. Catalog No. 5846-03, Lot No. WB78282; 43. Catalog No. 5859-03, Lot Nos. WB67984, WB78671, WB74703, WB83777, WB86429; 44. Catalog No. 5877-04, Lot Nos. WB77410; 45. Catalog No. 6011-04, Lot No. WB80720; 46. Catalog No. 6221-04, Lot No. WB77970; 47. Catalog No. 6222-07, Lot Nos. WB76951, WB82046; 48. Catalog No. 6223-07, Lot Nos. WB76952, WB81262; 49. Catalog No. 6297-03, Lot No. WB76475; 50. Catalog No. 6333-02, Lot No. WB79919; 51. Catalog No. 6420-02, Lot Nos. WB76282, WB81074; 52. Catalog No. 6457-02, Lot No. WB78305; 53. Catalog No. 6496-02, Lot No. WB67256; 54. Catalog No. 6621-02, Lot Nos. WB76485, WB80907; 55. Catalog No. 6658-05, Lot No. WB80204; 56. Catalog No. 6707-04, Lot No. WB77980; 57. Catalog No. 6738-01, Lot Nos. WB74933, WB79928; 58. Catalog No. 6828-02, Lot No. WB81081; 59. Catalog No. 6886-04, Lot No. WB76693; 60. Catalog No. 6985-01, Lot No. WB79118; 61. Catalog No. 6987-02, Lot No. WB78196; 62. Catalog No. 8008-01, Lot Nos. WB76085, WB78704; 63. Catalog No. 8109-01, Lot No. WB78232; 64. Catalog No. 8139-01, Lot No. WB80066; 65. Catalog No. 8807-11, Lot Nos. WB76577, WB80091; 66. Catalog No. 8808-12, Lot No. WB77493; 67. Catalog No. 8938-04, Lot Nos. WB74081, WB78800; 68. Catalog No. 9364-13, Lot No. WB80117; 69. Catalog No. 9379-17, Lot Nos. WB66937, WB68609, WB72711, WB75023, WB76334, WB77031, WB78477, WB80006; 70. Catalog No. 9452-14, Lot No. WB80123; 71. Catalog No. 9521-23, Lot No. WB76532, WB78266, WB80263; 72. Catalog No. 9593-08, Lot No. WB76071; 73. Catalog No. 9610-09, Lot Nos. WB78831, WB80773, WB74968, WB77528; 74. Catalog No. 9611-13, Lot Nos. WB77529, WB80141; 75. Catalog No. 9710-12, Lot No. WB69145; 76. Catalog No. 9710-13, Lot Nos. WB72868, WB80027, WB84739; 77. Catalog No. 9853-23, Lot Nos. WB76545, WB77477, WB78969, WB80277; 78. Catalog No. 9890-07, Lot Nos. WB76093, WB80784; 79. Catalog No. Q21624C, Lot No. P13750; 80. Catalog No. Q22446A, Lot No. P13897; 81. Catalog No. Q22658, Lot No. P13947.
MANUFACTURER
Graphic Controls Corporation, Chatsworth, California (Devon
Needle Counters).
RECALLED BY
Alcon Laboratories, Inc., Houston, Texas (kit assembler), by
telephone on August 24, 1998, followed by letter on August 28,
1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
3,996 kits were distributed.
REASON
The kits contain Devon needle counters recalled by Graphic
Control Corp., Buffalo, New York, because the foam strip used to
secure suture needles was detaching from the needle counter
box.
a) Solid Phase No Boil Folic Acid Kit, Catalog No. KDSP1, 100 Test Kit Size; b) Solid Phase No Boil Folic Acid Kit, Catalog No. KDSP2, 200 Test Kit Size; c) Solid Phase No Boil Folic Acid Kit, Catalog No. KDSP5, 500 Test Kit Size; d) Dualcount Solid Phase No Boil Folic Acid/Vitamin B12 Kit, Catalog No. KFSP1, 100 Test Kit Size; e) Dualcount Solid Phase No Boil Folic Acid/Vitamin B12 Kit, Catalog No. KFSP2, 200 Test Kit Size; f) Dualcount Solid Phase No Boil Folic acid/vitamin B12 Kit, Catalog No. KFSP5, 500 Test Kit Size. Recall #Z-828/833-8.
CODE
Lot numbers: a) 674 and 675; b) 527; c) 517; d)457 and 458;
e)438; f)418 and 419.
MANUFACTURER
Diagnostic Products Corporation (DPC), Los Angeles,
California.
RECALLED BY
Manufacturer, by telephone between June 12 and 23, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Arizona, California, Connecticut, Indiana, Massachusetts,
Maryland, Michigan, New York, Wisconsin, Wyoming, Florida,
international.
QUANTITY
1,100 kits were distributed; firm estimates none remains on the
market.
REASON
The folate control values are elevated and exceed the limits of
acceptability.
PRODUCT
Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens
Buttons, Catalog #2600-B. Recall #Z-874-8.
CODE
Lot #0035951.
MANUFACTURER
Polymer Technology, a division of Wilmington Partners, LP,
Wilmington, Massachusetts.
RECALLED BY
Polymer Technology, a division of Wilmington Partners, LP
(subsidiary of Bausch & Lomb, Inc.), Rochester, New York, by
letters dated August 30, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
15,297 buttons were distributed.
REASON
Particulate matter has been found in some lens buttons.
PRODUCT
Navarre 6 French Locking Pigtail Universal Drainage Catheter,
Product NUD6LPT, used only in non-vascular drainage procedures,
for abscess, cyst, and other general purpose drainage
applications. Recall #Z-875-8.
CODE
Lot #980540, Use by 2001-07.
MANUFACTURER
Navarre Biomedical, Ltd., Plymouth, Minnesota.
RECALLED BY
Manufacturer, by telephone starting on September 1, 1998.
Firm-initiated field correction complete.
DISTRIBUTION
California, Florida, Massachusetts, Minnesota, Missouri, Nevada,
New York, Oklahoma, Pennsylvania, Texas.
QUANTITY
100 catheters were distributed.
REASON
The recommended guidewire size on the product labels was
incorrect.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 30, 1998. BLANK PAGES MAY FOLLOW. ####