Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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December 24, 2008
08-51

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
a) Seattle 's Favorite brand Banana Nut Muffin Top in clear plastic wrap; UPC: 6 98840 03060 0, Recall # F-054-9;

b) Seattle 's Favorite brand Orange Cranberry Muffin Top; UPC: 6 98840 03050 1, Recall # F-055-9
CODE
Not coded
RECALLING FIRM/MANUFACTURER
Seattle's Favorite, LLC, Tukwila, WA, by telephone, press release, web site and emails and letters on November 14, 2008. Firm initiated recall is complete.
REASON
Product contains undeclared milk (whey).
VOLUME OF PRODUCT IN COMMERCE
Banana Nut: 17,516 packages / Orange Cranberry: 77,730 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Stop and Shop brand Butternut Squash 24 oz. packages; UPC 88267 08964. Packaged in square black container with a clear plastic over seal, and was sold only in the Stop and Shop Thanksgiving Dinner Kits and not sold as an individual unit, Recall # F-056-9
CODE
Dated from 12/05 through 12/10
RECALLING FIRM/MANUFACTURER
Simmering Soups, Inc., Cumberland , RI , by letter, email, telephone and press release on November 24, 2008. Firm initiated recall is complete.
REASON
Product contains undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
40,000 units
DISTRIBUTION
NJ, NY, CT, RI, MA, VT, NH and ME
___________________________________
PRODUCT
Wegmans Italian Classics Seasoned Tomato Sauce, Net Wt. 24 oz (1 lb 8 oz) 680 g, UPC: 77890 79010. Product is packaged in 24 oz. flexible, clear pouches, Recall # F-057-9
CODE
Use by 11/26/08
RECALLING FIRM/MANUFACTURER
Wegmans Food Markets, Rochester , NY , by letter, email and press release on November 20, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
108 cases
DISTRIBUTION
NY, PA, NJ, VA, and MD
___________________________________
PRODUCT
a) Frozen, Cooked Lobster RTE Meat, Claw & Knuckle Meat 6 x 907G/2 lbs. Net wt. 5.45kg/12 lbs per case. Not labeled for retail sale, Recall # F-058-9;

b) RTE Frozen, Cooked lobster meat, claw & knuckle meat 12 x 6 oz. Net wt. 170G (6 oz.)/12 per case, Recall # F-059-9;

c) Claw Island RTE, Frozen, Cooked lobster meat, claw & knuckle meat IQF 3 x 2 lb. Net wt. 3X2#, Recall # F-060-9
CODE
Lot numbers: 24508 through 29708
RECALLING FIRM/MANUFACTURER
Portland Shellfish Co., Inc., South Portland , ME , by telephone and press release on October 21, 2008, email on October 31, 2008 and by letter on November 3, 2008. Firm initiated recall is ongoing.
REASON
Products are contaminated with Listeria monocytogenes .
VOLUME OF PRODUCT IN COMMERCE
905 cases
DISTRIBUTION
CA, CT, FL, IL, MA, ME, NH, NY, NV, PA, TX, UT, Ireland, Italy, UK, Thailand, Switzerland
___________________________________
PRODUCT
VeganReuua” Cheddar Style, Natural Cheese Alternative, (No Dairy/Lactose Free), Net Wt. 8 oz (227g), UPC: 0-37983-00015-4; Item #600154, Recall # F-063-9
CODE
Sell by date 12/09/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Panos Brands, Inc., Saddle Brook , NJ , by letter on October 2, 2008 and by press release on November 20, 2008.
Manufacturer: Swan Garden/Tree of Live, Austell, GA. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
171 cases
DISTRIBUTION
CA, CO, FL, GA, IA, NH and WA

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
Wegmans New England Clam Chowder, Net Wt. 16 oz. Keep Refrigerated. Allergens: Contains Milk, Wheat. Microwave container with aluminum pull tap and plastic snap on lid, Recall # F-061-9
CODE
Lot 326 and 331
RECALLING FIRM/MANUFACTURER
Neco Foods, Lantana, FL, by telephone on December 1, 2008. Firm initiated recall is complete.
REASON
Product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
354 cases) 4248 units of 16 oz. containers
DISTRIBUTION
NY
___________________________________
PRODUCT
Premium Poppers Cheese Flavored Gourmet Popcorn , 7 oz, (198g); UPC: 93034 04449, Recall # F-062-9
CODE
Lot numbers: 010209, 122808, 122908 and 121908
RECALLING FIRM/MANUFACTURER
Premium Poppers Popcorn Co., Gainesville , TX , by visit beginning on November 18, 2008. Firm initiated recall is ongoing.
REASON
Product contains undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
936/7 oz. bags (117 cases)
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0020-09
CODE
Unit: 53LW49921
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore , MD , by telephone and letter on June 7, 2006 and June 8, 2006. Firm initiated recall is complete.
REASON
Blood product, in which the corresponding blood component was possibly contaminated with Streptococcus viridans and Staphylococcus coagulase negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0054-09
CODE
Units: 19FS43576; 19GC28070; 19GC28585; 19FS45001
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville , TN , by electronic mail on March 10, 2008. Firm initiated recall is complete.
REASON
Blood products, which were not tested for Nucleic Acid Testing (NAT), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0313-09
CODE
Unit: 8307469
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville , FL , by fax on March 18, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not properly quarantined after receiving information concerning post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0317-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0318-09
CODE
a) Unit: 5541895;
b) Unit: 8813467
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota , FL , by email on March 10, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0319-09
CODE
Unit: 72E796509
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville , FL , by fax on February 4, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Inverness , FL. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0328-09
CODE
Unit: 3409301
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center , Tallahassee , FL , by letter dated March 13, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication Evista, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0330-09
CODE
Units: G80869, G80868, G80872, G80874, G80875, G80878
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center , Springfield , IL , by facsimile and letter on July 22, 2008. Firm initiated recall is complete.
REASON
Blood products, which were missing documentation of the leukoreduction process, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0331-09
CODE
Unit: W288008000557
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview , IL , by telephone on August 1, 2008.
Manufacturer: LifeSource Oak Lawn, Oak Lawn , IL . Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets Leukocytes Reduced, Recall # B-0314-09
CODE
Unit: 019LG35157
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville , TN , by telephone and letter on April 11, 2007. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood with a collection time discrepancy, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS. Its intended use is for ultrasound examination of intravascular pathology, Recall # Z-0338-2009
CODE
ILAB120CART: UPN: H749ILAB120CARTD0 Serial #s: 4033 4058 4063 4098 4171 ACQUISITION PC: UPN: H749ILACQPCFRU010 H749ILACQPCFRU01D0 H749ILACQPCFRU01H0 H749ILACQPCFRU01R0 H749ILACQPCFRU01Z0 H749ILACQPCFRU020 H749ILACQPCFRU02D0 H749ILACQPCFRU02H0 H749ILACQPCFRU02R0 H749ILACQPCFRU02Z0 H749ILACQPCFRU030 H749ILACQPCFRU03H0 H749ILACQPCFRU03R0 H749ILACQPCFRU03Z0 H749ILACQPCFRU040 H749ILACQPCFRU04R0 H749ILACQPCFRU04Z0 H749ILACQPCFRU050 H749ILACQPCFRU05R0 H749ILACQPCFRU05Z0 H749ILACQPCFRU060 H749ILACQPCFRU06R0 and H749ILACQPCFRU06Z0 Serial #s: 1580359 1611146 L10076 L10227 L10442 L10714. 1580642 1611147 L10081 L10233 L10443 L10717 1581015 1611152 L10083 L10239 L10444 L10739 1581022 1611153 L10086 L10243 L10456 L10761 1581024 1611192 L10093 L10255 L10464 L10766 1582415 1611195 L10095 L10257 L10471 L10774 1582418 1611200 L10099 L10269 L10511 L10776 1582871 1611416 L10109 L10284 L10531 L10782 1582881 1611422 L10113 L10292 L10541 L10785 1583625 1611423 L10115 L10309 L10543 L10807 1583628 1611424 L10120 L10311 L10555 L10809 1583629 1611429 L10122 L10314 L10556 L10838 1583634 1611430 L10125 L10318 L10562 L10840 1583635 1611434 L10129 L10320 L10565 L10855 1583636 1611702 L10130 L10332 L10579 L10863 1583637 16081315 L10131 L10336 L10582 L10867 1583638 L10000 L10132 L10345 L10588 L10873 1583641 L10002 L10139 L10357 L10589 L10878 1583643 L10006 L10162 L10362 L10593 L10900 1588611 L10010 L10164 L10365 L10597 L10909 1590153 L10016 L10166 L10369 L10603 L10920 1607244 L10018 L10168 L10371 L10611 L10946 1607292 L10021 L10169 L10375 L10617 L10953 1607482 L10024 L10170 L10377 L10619 L10963 1607721 L10026 L10177 L10382 L10620 L10970 1607723 L10028 L10178 L10399 L10624 L10981 1608316 L10033 L10179 L10407 L10627 L10991 1609451 L10055 L10180 L10419 L10632 L10999 1609454 L10057 L10186 L10422 L10648 L11022 1611078 L10070 L10188 L10430 L10665 L11035 1611080 L10071 L10195 L10434 L10679 L11036 1611081 L10072 L10196 L10436 L10680 L11040 1611085 L10074 L10198 L10439 L10691 L11052 1611144 L10075 L10207 L10440 L10710 L11060 and Model UPN Serial # IMAGE PROCESSOR H749ILIMGPCFRU010 H749ILIMGPCFRU01D0 H749ILIMGPCFRU01H0 H749ILIMGPCFRU01R0 H749ILIMGPCFRU01Z0 H749ILIMGPCFRU020 H749ILIMGPCFRU02R0 H749ILIMGPCFRU02Z0 H749ILIMGPCFRU030 H749ILIMGPCFRU03R0 and H749ILIMGPCFRU03Z0 296968 313715 321630 322849 336162 340786. 297060 313717 321631 322861 336163 340792 297061 313720 321632 327138 336253 340805 297062 314198 316790 327148 336256 340809 297063 314203 316792 327150 336257 341460 300862 314218 316801 329820 336269 342235 300865 314223 316802 329823 336343 342237 300866 315336 316803 329825 336344 342243 300868 315340 321641 329836 336349 342752 300876 315343 321642 329844 336718 342773 302076 315344 321647 329867 336720 806347299 302079 315426 321650 331555 336727 806347312 303104 315427 321651 331556 336734 806347323 303108 315434 323025 331564 336735 806347324 304636 315708 323029 331582 336795 806347327 304637 315709 323037 331590 336807 807348245 304640 315710 323039 332318 337432 807348248 305670 315714 323058 332319 337456 807348253 305675 315716 324211 332328 337480 807348257 306636 315720 324221 332339 338772 807348259 306637 315721 324225 332348 338777 807348268 306640 315723 324236 332349 338789 807348271 307244 315724 324240 332352 338808 807348273 307246 315725 324241 332356 338815 807348278 307247 316840 324243 332360 339827 807348279 307248 316847 324245 332374 339830 807348280 307252 316979 324256 332690 339831 807348281 307255 316984 325724 332699 339838 807348283 307770 316991 325740 332710 339839 807348286 307771 317220 325742 332715 339841 807348287 307772 317223 325745 332729 339842 807348288 307773 317235 325756 333368 339843 807348292 307777 317253 325775 333372 340048 807348293 307782 317662 325777 333373 340049 807348294 308093 317664 325778 333374 340053 807348296 308100 317668 327115 333375 340054 807348704 309466 321294 327122 333376 804344578 807348709 309469 321300 327133 333377 804344579 807348714 309470 321448 327136 333379 804345552 807348715 309475 321457 321652 333380 805346232 807348719 309476 321615 321656 333381 805346239 807348728 310273 321617 321662 333382 340067 807349080 310276 321622 321663 333385 340760 807349088 and 310277 321623 321664 333390 340767 310282 321625 321665 335825 340779 313712 321627 322846 336155 340781
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Fremont , CA , by letters on September 5, 2008. Firm initiated recall is ongoing.
REASON
Computer malware: Products may be infected with a worm (computer malware) which could infect a computer network to which it may be connected.
VOLUME OF PRODUCT IN COMMERCE
482 units
DISTRIBUTION
Nationwide, Europe, Middle East, Africa, and Japan .
___________________________________
PRODUCT
a) Arjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale. A Non-AC-Powered Patient Lift. Model KM560101, and Model KM560001 - Maxi 500 with 2-Point Spreader Bar, if it was equipped with the optional scale kit 700.05505. The Maxi 500 is a mobile passive lifter, intended to be used for lifting and transferring of patients in hospitals, nursing homes of other health care facilities, Recall # Z-0412-2009;

b) Arjo Maxi 500 Patient Lift with Manual 4-Point DPS (Dynamic Positioning System) and Scale. A Non-AC-Powered Patient Lift. Model KM560181 and Model KM560081 - Maxi 500 with 4-Point Spreader Bar, if it was equipped with the optional scale kit 700.19251, Recall # Z-0413-2009
CODE
a) Serial numbers: KM5611219, KM5611322, KM5611076, KM5610713, KM5610729, KM5610737, KM5610114, KM5610115, KM5610550, KM5610711, KM5610551, KM5610693, KM5610694, KM5610696, KM5611003, KM5611004, KM5611005, KM5611006, KM5611007, KM5611008, KM5611009, KM5611010, KM5611011, KM5611012, KM5611013, KM5611014, KM5611015, KM5611016, KM5611017, KM5611018, KM5611019, KM5611020, KM5611021, KM5611022, KM5611023, KM5611024, KM5611025, KM5611026, KM5611027, KM5611084, KM5610813, KM5611290, KM5610667, and KM5611321;
Serial numbers: SO#5140275 and SO#5156094;

b) Serial numbers: KM5610035, KM5610036, KM5610037, KM5610038, KM5610039, KM5610040, KM5610041, KM5610042, KM5610043, KM5610044, KM5610045, KM5610046, KM5610047, KM5610048, KM5610049, KM5610050, KM5610051, KM5610052, KM5610053, KM5610054, KM5610055, KM5610056, KM5610057, KM5610058, KM5610059, KM5610060, KM5610061, KM5610062, KM5610063, KM5610064, KM5610065, KM5610066, KM5610096, KM5610097, KM5610098, KM5610099, KM5610100, KM5610101, KM5610102, KM5610103, KM5610104, KM5610105, KM5610106, KM5610107, KM5610108, KM5610109, KM5610110, KM5610111, KM5610112, KM5610113, KM5610116, KM5610117, KM5610118, KM5610119, KM5610120, KM5610121, KM5610122, KM5610123, KM5610124, KM5610125, KM5610126, KM5610127, KM5610128, KM5610129, KM5610130, KM5610131, KM5610132, KM5610133, KM5610152, KM5610153, KM5610154, KM5610155, KM5610156, KM5610157, KM5610158, KM5610159, KM5610160, KM5610161, KM5610162, KM5610163, KM5610164, KM5610165, KM5610166, KM5610167, KM5610168, KM5610169, KM5610170, KM5610171, KM5610173, KM5610176, KM5610177, KM5610178, KM5610179, KM5610180, KM5610181, KM5610182, KM5610187, KM5610235, KM5610236, KM5610237, KM5610238, KM5610239, KM5610240, KM5610241, KM5610242, KM5610243, KM5610244, KM5610245, KM5610246, KM5610247, KM5610249, KM5610250, KM5610251, KM5610253, KM5610254, KM5610257, KM5610260, KM5610261, KM5610262, KM5610263, KM5610264, KM5610265, KM5610266, KM5610267, KM5610268, KM5610269, KM5610270, KM5610271, KM5610272, KM5610273, KM5610274, KM5610275, KM5610276, KM5610278, KM5610280, KM5610281, KM5610282, KM5610284, KM5610285, KM5610286, KM5610288, KM5610289, KM5610290, KM5610291, KM5610292, KM5610293, KM5610294, KM5610295, KM5610296, KM5610297, KM5610298, KM5610299, KM5610300, KM5610301, KM5610302, KM5610303, KM5610304, KM5610305, KM5610306, KM5610307, KM5610308, KM5610309, KM5610310, KM5610311, KM5610312, KM5610313, KM5610314, KM5610315, KM5610316, KM5610317, KM5610318, KM5610319, KM5610320, KM5610321, KM5610322, KM5610323, KM5610324, KM5610325, KM5610326, KM5610327, KM5610328, KM5610329, KM5610330, KM5610331, KM5610332, KM5610333, KM5610334, KM5610335, KM5610336, KM5610337, KM5610338, KM5610339, KM5610340, KM5610341, KM5610342, KM5610343, KM5610406, KM5610407, KM5610408, KM5610409, KM5610410, KM5610411, KM5610412, KM5610413, KM5610414, KM5610415, KM5610416, KM5610417, KM5610418, KM5610419, KM5610420, KM5610421, KM5610422, KM5610423, KM5610424, KM5610425, KM5610426, KM5610427, KM5610428, KM5610429, KM5610430, KM5610431, KM5610432, KM5610433, KM5610434, KM5610435, KM5610436, KM5610437, KM5610438, KM5610439, KM5610440, KM5610441, KM5610596, KM5610700, KM5610701, KM5610702, KM5610703, KM5610704, KM5610722, KM5610723, KM5610724, KM5610725, KM5610726, KM5610735, KM5610736, KM5610748, KM5610749, KM5610750, KM5610751, KM5610752, KM5610753, KM5610754, KM5610755, KM5610756, KM5610757, KM5610758, KM5610784, KM5610785, KM5610786, KM5610787, KM5610788, KM5610805, KM5610806, KM5610808, KM5610814, KM5610815, KM5610816, KM5610817, KM5610818, KM5610824, KM5610825, KM5610826, KM5610827, KM5610828, KM5610830, KM5610831, KM5610832, KM5610833, KM5610839, KM5610840, KM5610841, KM5610842, KM5610843, KM5610849, KM5610850, KM5610851, KM5610852, KM5610853, KM5610854, KM5610855, KM5610856, KM5610857, KM5610858, KM5610878, KM5610879, KM5610880, KM5610881, KM5610888, KM5610889, KM5610890, KM5610891, KM5610892, KM5610913, KM5610914, KM5610915, KM5610916, KM5610950, KM5610951, KM5610952, KM5610953, KM5610954, KM5610978, KM5610980, KM5610981, KM5610982, KM5610983, KM5610984, KM5610985, KM5610986, KM5610987, KM5610988, KM5610989, KM5610990, KM5610991, KM5610992, KM5610998, KM5610999, KM5611001, KM5611002, KM5611093, KM5611096, KM5611097, KM5611098, KM5611099, KM5611101, KM5611121, KM5611123, KM5611124, KM5611125, KM5611137, KM5611138, KM5611139, KM5611187, KM5611188, KM5611190, KM5611233, KM5611235, KM5611237, KM5611293, KM5611294, KM5611295, KM5611296, KM5611307, KM5611324, KM5611327, KM5611329, KM5611330, KM5611331, KM5611395, KM5611396, KM5611402, KM56510015, KM56510016, KM56510017, KM56510018, KM56510019, KM56510020, KM56510021, KM56510022, KM56510023 and KM56510024;
Serial numbers: SO#5178400, SO#5143612, SO#5204405, SO#5186264, SO#5137047, SO#5150226, SO#5156912, SO#5162379, SO#5165403 and SO#5142409
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle , IL , by letter dated October 29, 2008.
Manufacturer: B. H. M. Medical, Inc., Magog , Canada . Firm initiated recall is ongoing.
REASON
If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment.
VOLUME OF PRODUCT IN COMMERCE
415 lifts; 12 scale kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Vidiera NsP Nucleic Sample Preparation, Part Number: A22421, Version 1.0.41, Recall # Z-0454-2009
CODE
Version 1.0.41
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea , CA , by telephone and letter on September 11, 2007.
Manufacturer: Beckman Coulter Inc., Fullerton , CA. Firm initiated recall is ongoing.
REASON
Incorrect results: under certain circumstances, when transfer volume is not within the set range, the Vidiera NsP software does not report sample exclusion and does not flag the excluded sample in the "Run Results" report.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ACE and ACE Alera Hemoglobin A1C : EZA1C Reagent, EZA1C Controls, and EZA1C Calibrators. Hemoglobin A1c (EZA1c) Calibrators for Calibration of the Enzymatic Hemoglobin A1c (HbA1c) Assay. For in vitro diagnostic use only. ACE EZA1c Reagent is intended for the quantitative determination of stable hemoglobin A1c in human whole blood samples using the ACE and Ace Alera clinical chemistry systems. Measurement of hemoglobin A1c is a viable indicator for long-term diabetic control. a) EZA1c Reagent ACI-30, and b) EZA1c Reagent ACI-30. The following EZA1c control and calibrator kits were included in the customer notification instructing them to discard the product. There is no use for these products without the reagent, (EZA1c Controls C2-82, and EZA1c Calibrators S2-82), Recall # Z-0482-2009
CODE
a) Lot # F2481, Exp. 9/2008 and b) Lot # F2603, Exp 01/2009;
(Lot # HBC00507-1, Exp. 10/2008 and Lot # HBS00907-1, Exp. 10/2008)
RECALLING FIRM/MANUFACTURER
Alfa Wassermann, Inc., Caldwell , NJ , by letters dated August 22, 2008 and September 18, 2008. Firm initiated recall is ongoing.
REASON
Internal studies observed occasional unexpected outlier results in whole blood samples tested for Hemoglobin A1c using the EZA1c reagent on the ACE or ACE Alera clinical chemistry systems.
VOLUME OF PRODUCT IN COMMERCE
917 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) FHC MicroTargeting Electrode, MTDWBP(AR)(MP I ) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain, Recall # Z-0497-2009;
b) FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive. REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain, Recall # Z-0498-2009;
c) FC400SP MicroTargeting StimPilot Single Procedure Kit, Ref: FHC4000SP. Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain, Recall # Z-0499-2009
CODE
a) Lot #'s: 47647 and 475611;
b) Lot #: 866051
c) Serial #'s: 01689 through 01708 and 01756 through 01758
RECALLING FIRM/MANUFACTURER
FHC, Inc., Bowdoinham , ME , by letter dated October 20, 2008. Firm initiated recall is ongoing.
REASON
Mislabeled: May contain an electrode longer than labeled size.
VOLUME OF PRODUCT IN COMMERCE
256 electrodes
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
a) STA Neoplastine CI 10; Product Catalogue Number: 0666, Recall # Z-0501-2009;
b) STA Neoplastine CI Plus 10; Product Catalogue Number: 0667, Recall # Z-0502-2009
C ODE
a) Lot #'s: 101393, 101465, 101676, and 102269; Lot
b) Lot #'s: 100439, 101126, 101601, 100755, 101231, 101602, 100975, 101419, 101726, 100995, 101420, 101856, 101002, 101600, and 101955
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany , NJ , by letters on October 20, 2008.
Manufacturer: Diagnostica Stago - Taverny Site, Taverny, France . Firm initiated recall is ongoing.
REASON
Internal investigation has determined the potential lack of homogeneity between product vials.
VOLUME OF PRODUCT IN COMMERCE
a) 1,280 units; b) 31,207 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Maxi Move, Model NDA0200-20 Batteries Pack. The equipment is intended to be used in Hospitals, nursing homes, or other health care facilities by trained caregivers for the transfer of patients. This battery pack was solely supplied with Maxi Move floor lift model numbers starting with KCxxx or sold separately as replacement parts, Recall # Z-0503-2009
CODE
Lot #: 070826D
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle , IL , by Field Safety Notice dated October 31, and letter dated November 5, 2008.
Manufacturer: B. H.M. Medical, Inc., Magog , Canada . Firm initiated recall is ongoing.
REASON
The battery pack has a defective connector that could lead to the inability of the battery pack to recharge and/or short circuit, resulting in smoke emission.
VOLUME OF PRODUCT IN COMMERCE
273 battery packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 performing ultrasound guided biopsies of the prostate, Recall # Z-0504-2009
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bk Medical, Lierlev , Denmark , by letter dated September 3, 2008.
Manufacturer: Mepy Systems, Saint Jean , France . Firm initiated recall is complete.
REASON
No 510k approved.
VOLUME OF PRODUCT IN COMMERCE
664 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Cannabinoids Intercept Micro Plate EIA 100 plate kit; Product number 11181C, Recall # Z-0481-2009
CODE
Lot # 6609532, Exp: 12/2008
RECALLING FIRM/MANUFACTURER
OraSure Technologies, Inc., Bethlehem , PA , by telephone on September 8, 2008 and by letter dated September 11, 2008. Firm initiated recall is complete.
REASON
Readings , high: intermittent high absorbance readings.
VOLUME OF PRODUCT IN COMMERCE
1 kit
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Hartz Chicken Basted Rawhide Chips; UPC 32700 96463 9, Recall # V-004-2009
CODE
Lot : JC23282
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hartz Mountain Corp., Secaucus , NJ , by press release and letters on October 17, 2008.
Manufacturing: BERTIN LTDA, Guaicara, Sao Paulo , Brazil . Firm initiated recall is ongoing.
REASON
Test results detected the presence of salmonella .
VOLUME OF PRODUCT IN COMMERCE
4,850 bags
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
___________________________________
PRODUCT
Sheep Balancer B136 Medicated, packaged in 50-lb. bags, containing 136.0 g/t lasalocid, Recall # V-005-2009
CODE
Unit: 8OCT08LNC1
RECALLING FIRM/MANUFACTURER
Land O'Lakes Purina Feed LLC, Lincoln , NB , by press release, telephone and letters dated December 4, 2008. Firm initiated recall is ongoing.
REASON
High copper level
VOLUME OF PRODUCT IN COMMERCE
208/50-lb. bags
DISTRIBUTION
NB and IA

END OF ENFORCEMENT REPORT FOR DECEMBER 24, 2008

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