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Enforcement Report for November 21, 2007

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.

November 21, 2007
07-47

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Halla Food brand Fat Free Puffed Rice Snack, 74g (2.59oz). The snack cakes are packaged in flexible plastic packaging with yellow, red and blue printing. UPC number: "6 09071 10 101 4", Recall # F-038-8
CODE
No code
RECALLING FIRM/MANUFACTURER
Halla Food Co, Inc., S El Monte, CA, by letter on October 4, 2007. Firm initiated recall is ongoing.
REASON
The product contains undeclared wheat flour.
VOLUME OF PRODUCT IN COMMERCE
100 boxes/16 bags per box
DISTRIBUTION
CA, GA, WI
___________________________________
PRODUCT
Kellogg Crispix cereal packaged in 12 ounce cartons, 14 cartons in a case. Carton UPC 3800003530; Case UPC 3800003513, Recall # F-039-8
CODE
Best if Used by Date on Carton: SEP 22 2008 KLC. Date/time code on case of KL 09228 C 22:26 through KL 09228 C 23:00
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg USA, Inc., Battle Creek, MI, by letter dated November 9, 2007.
Manufacturer: Kellogg Co., Lancaster, PA. Firm initiated recall is ongoing.
REASON
Raisin bran may be mixed with the product in some of the boxes, resulting in the presence of undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
8,400 cartons
DISTRIBUTION
AR, IL, ND, OK, and TX

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Ampicillin for Injection, USP, ampicillin sodium equivalent to 250 mg ampicillin RX only; a lyophilized powder for injection antibiotic in a single dose vial, 10 vials per shelf carton; Made in Italy; product number 308710, NDC 63323-387-10, Recall # D-027-2008
CODE
Lot numbers: 7B04AJ, exp. 01/31/2010; 7D06AJ, exp. 03/31/2020; 7F07AJ, exp. 04/30/2010; 7G11AJ, exp. 05/31/2010. The recall was expanded on 11/8/07 to include lot 7A03AJ, Exp 12/31/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis Pharmaceutical Products, Rosemont, IL, by letters dated October 18, 2007.
Manufacturer: IBI - Istituto Biochimico Italiano S.p.A, Aprilia, Italy. Firm initiated recall is ongoing.
REASON
Mislabeled; incorrect dilution instructions printed on outer carton.
VOLUME OF PRODUCT IN COMMERCE
200,700 vials
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Potassium Citrate Extended Release Tablets USP, 10 mEq (1080 mg per tablet), 100-tablet bottles, Rx Only, NDC 64980-138-01, Recall # D-040-2008
CODE
Lot: CPF698, exp. 06/08
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middlesex, NJ, by letter on October 23, 2007. Firm initiated recall is ongoing.
REASON
Product may exceed impurity specification for oxalic acid.
VOLUME OF PRODUCT IN COMMERCE
3,503-100 tablet bottles
DISTRIBUTION
NJ
___________________________________
PRODUCT
Aspirin, enteric coated, 81 mg., OTC, packaged under the following brand names: TOP CARE, 120 tablets, NDC 36800-535-76; Equate, 120 tablets, NDC 49035-535-76; American Fare, 365 tablets, NDC 49738-535-88; GoodSense, 120 tablets, NDC 0113-0535-76; Western Family, 120 tablets; Safeway, 120 tablets, NDC 21130-535-76; Meijer, 120 tablets, NDC 41250-535-76; Sunmark, 120 tablets, NDC 49348-756-53; H-E-B, 120 tablets, NDC 37808-535-76; Good Neighbor Pharmacy, 120 tablets, NDC 24385-535-76, and CARxEONE, 120 tablets, Recall # D-041-2008
CODE
Lots: 5GE0118, 5HE0086 and 5HE0589; Exp. 03/2008
RECALLING FIRM/MANUFACTURER
L. Perrigo, Co., Allegan, MI, by letter dated October 15, 2007. Firm initiated recall is ongoing.
REASON
Failed dissolution during 24 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
85,596 tablets
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Wyeth***ADD-Vantage Vial NDC0206-8852-16***2.25gram Zosyn***Piperacillin and Tazobactam***for injection***For IV Use***10x2.25 gram***, Recall # D-042-2008
CODE
Lot # C00438 Exp. Date: April 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Ayerst Laboratories, Philadelphia, PA, by telephone on October 10, 2007.. 
Manufacturer: Wyeth Piperacillin Division of Wyeth Holdings Corp. Carolina, PR. Firm initiated recall is ongoing..
REASON
There is a lack of assurance that the lots is within acceptable quality limits with respect to vial fill levels.
VOLUME OF PRODUCT IN COMMERCE
12 trays of 10 vials each = 120 vials
DISTRIBUTION
IL, MA, and TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0098-08
CODE
Unit: 7224206
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK,  by telephone on February 12, 2007 and fax on February 15, 2007. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0136-08;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-0137-08;
c) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0138-08;
d) Platelets Pheresis Leukocytes Reduced Washed, Recall # B-0139-08
CODE
a) Units: 7092366 and 7090162;
b) Units: 7084169, 7088495 (split unit), and 7090162;
c) Units 7084169 and 7088495;
d) Unit 7090162
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on May 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 components
DISTRIBUTION
TX
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0163-08;
b) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0164-08;
c) Platelets Pheresis Leukocytes Reduced, Recall # B-0165-08;
d) Fresh Frozen Plasma, Recall # B-0166-08;
e) Cryoprecipitated AHF, Recall # B-0167-08;
f) Plasma Cryoprecipitate Reduced, Recall # B-0168-08;
CODE
a) Units: 12C43446, 12C43453, 12C43455, 12C43456, 12C43460, 12C43469,
    12F46064, 12F46076, 12F46078, 12KQ39615, 12KQ39619, 12KQ39644,
    12KQ39645, 12C43448, 12C43449, 12C43450, 12C43451, 12C43452, 12C43457,  
    12C43458, 12C43461, 12C43463, 12C43464, 12C43465, 12C43468, 12C43470,  
    12F46056, 12F46057, 12F46058, 12F46061, 12F46063, 12F46065, 12F46068,  
    12F46069, 12F46070, 12F46072, 12F46073, 12F46074, 12F46075, 12F46077,  
    12KQ39620, 12KQ39621, 12KQ39624, 12KQ39626, 12KQ39627, 12KQ39630,
    12KQ39633, 12KQ39634, 12KQ39636, 12KQ39637, 12KQ39640, 12KQ39642,
    12KQ39643, 12LN37403, 12LN37404, 12LN37405, 12LN37407, 12LN37410,
    12LN37411, 12LN37412, 12LN37413, 12LN37414, 12LN37416, 12LN37417,
    12LN37418, 12LN37419, 12LN37421, 12LN37422, 12LN37423, 12LN37424,
    12LN37425, 12LN37428, 12LN37429, 12LN37430, 12LN37431, 12LN37432,
    12LN37437, 12LN37438, 12LN37440, 12LN37441, 12LN37442, 12LN37444,
    12LN37445, 12LN37447, 12LN37448, 12LN37449, 12LN37451, 12LN37456,
    12LN37459, 12LN37460, 12LN37461, 12R46066, 12R46069, 12R46070,
    12R46071, 12R46072, 12R46074, 12R46075, 12R46076, 12R46077, 12R46078,
    12R46080, 12R46081, 12R46082, 12R46085, 12R46086, 12R46087, 12R46088,
    12R46089, 12R46093, 12R46094, 12R46096, 12R46097, 12R46098, 12X17605,
    12X17575, 12X17576, 12X17578, 12X17579, 12X17580, 12X17582, 12X17583,
    12X17585, 12X17586, 12X17588, 12X17592, 12X17593, 12X17594, 12X17595,
    12X17596, 12X17597, 12X17598, 12X17601, 12X17602, 12X17603, 12X17604,
    12X17607, 12X17609, 12X17610, 12X17611, 12X17612, 12Y49747, 12Y49748,
    12Y49749, 12Y49750, 12Y49752, 12Y49753, 12Y49754, 12Y49755, 12Y49756,
    12Y49757, 12Y49760, 12Y49763, 12Y49764, 12Y49765, 12Y49766, 12Y49769,
    12Y49770, 12Y49771, 12Y49775, 12Y49778, 12Y49784, 12Y49787, 12Y49788,
    12Y49790, 12Y49792, 12Y49793, 12Y49794, 12Y49796, 12Y49797, 12Z53660,
    12Z53661, 12Z53663, 12Z53664, 12Z53666, 12Z53667, 12Z53670, 12Z53672,
    12Z53673, 12Z53674, 12Z53675, 12Z53676, 12Z53679, 12Z53680, 12Z53682,
    12Z53683, 12Z53685, 12Z53686, 12Z53690, 12Z53691, 12Z53692, 12Z53693,
    12Z53696, 12Z53697, 12Z53701, 12Z53702, 12Z53703, 12Z53704, 12Z53705,
    12Z53706, 12LN37426, 12LN37427, 12R46073, 12X17577, 12X17600, 12X17606,
    12Y49758, 12Y49759, 12Y49768, 12Y49772, 12Y49773, 12Y49776, 12Y49777,
    12Y49780, 12Y49782, 12Y49783, 12Y49785, 12Y49786, 12Y49789, 12Y49791,
    12Y49799, 12Z53662, 12Z53669, 12Z53684, 12Z53689, 12Z53694, 12Z53695,
    12C43467, 12F46071, 12KQ39618, 12KQ39629, 12LN37436, 12LN37452,
    12R46068, 12R46083, 12R46084, 12X17590;
b) Units: 12H64823(Split product), 12H64824 (Split product), 12H64826 (Split product),
    12KL58876 (Split product), 12KL58877 (Split product), 12KL58879 (Split Product),
    12KL58880 (Split product), 12H64825 (Split product), 12H64827 (Split product),
    12KT28260 (Split product), 12KT28261 (Split product), 12KT28262 (Split product),
    12KL58875, 12KL58878;
c) Units: 12W88163, 12W88164 (split unit), 12W88169 (split unit), 12W88170
     (split unit), 12W88174 (split unit), 12W88176 (split unit), 12W88184 (split unit),
    12W88186 (split unit);
d) Units: 12F46066, 12F46067, 12F46068, 12F46069, 12F46070, 12F46071, 12F46073, 
    12F46074, 12F46075, 12F46076, 12F46078, 12KQ39637, 12KQ39641, 12C43457,
    12C43458, 12C43460, 12C43463, 12C43464, 12C43465, 12C43467, 12C43468, 
    12C43469, 12C43470, 12F46057, 12F46058, 12F46061, 12F46063, 12F46064, 
    12F46065, 12F46072, 12F46077, 12KQ39645, 12R46077, 12R46078, 12R46080, 
    12R46081, 12R46082, 12R46086, 12R46087, 12R46088, 12R46093, 12R46094, 
    12R46096, 12R46097, 12Z53663, 12Z53669, 12Z53670, 12Z53674, 12Z53675,
    12Z53686, 12Z53692, 12Z53693, 12Z53695, 12Z53696, 12Z53697, 12Z53699, 
    12Z53702, 12Z53704, 12Z5370512KQ39642, 12KQ39644, 12R46076, 12R46083,
    12R46089, 12Z53666, 12Z53672, 12Z53673, 12Z53689, 12Z53690, 12Z53691, 
    12Z53700, 12Z53701, 12Z53703;
e) Units: 12X17575, 12X17576, 12X17578, 12X17579, 12X17581, 12X17582,
    12X17583, 12X17586, 12X17601, 12X17602, 12X17604, 12X17605, 12X17606,
    12X17607, 12X17580, 12X17585, 12X17603, 12Y49760, 12Y49768,12X17609,
    12X17610, 12X17611, 12X17612, 12Y49757, 12Y49759, 12Y49782, 12Y49786;
f) Units: 12X17577, 12X17600, 12X17605, 12X17609, 12Y49787, 12Y49792,
    12Y49796, 12Y49763, 12Y49765, 12Y49783, 12Y49784, 12Y49785, 12Y49789,
    12Y49794, 12Y49797, 12Y49799
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone on February 25, 2004 and by letter on March 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which were not properly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
394 units
DISTRIBUTION
CA, GA, NC, NE, SC, and TN
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0180-08
CODE
Unit: 5744769
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, by fax on August 8, 2006.
Manufacturer: Oklahoma Blood Institute – Midwest City Donor Center, Midwest City, OK. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0182-08
CODE
Unit: E86180
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by letter dated August 16, 2007. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with air, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL:
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall B-0185-08
CODE
Unit: 71N860576
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone and fax on January 31, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell component which contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

*****CORRECTION*****

October 3, 2007 Enforcement Report, Recall # B-1558-07, Ortho Ficin Panel System Resolve Panel C A qualitative test for the identification of unexpected blood group antibodies. Under the Reason section it incorrectly stated that "Resolve Panel C, demonstrating unexpected reactivity with untreated Cell 16, was distributed." The cell in this kit demonstrating unexpected reactivity was Cell 6, not Cell 16.

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
a) Philips Medical System - BV Pulsera Mobil C-arms with Remote Control Option,
    Recall # Z-0059-2008;
b) Philips Medical System - Endura X-Ray Systems (Release 2) with Remote Control
    Option, Recall # Z-0060-2008
CODE
a) 21, 22, 30, 283, 284, 47, 51, 48, 301, 63, 73, 58, 46, 265, 267, 266, 87, 88, 89, 90,
    91, 92, 93, 94, 96, 97, 86, 107, 108, 120, 132, 141, 148, 177, 193, 155, 156, 157,
    158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 172, 173, 174, 175,
    185, 121, 176, 188, 195, 186, 187, 197, 198, 206, 201, 203, 204, 205, 213, 207, 208,
    209, 226, 229, 251, 244, 245, 248, 249, 250, 253, 254, 258, 275, 278, 287, 288, 292,
    289, 306, 305, 304, 294, 296, 297, 331, 330, 302, 309, 310, 320, 366, 367, 339, 329,     
    337, 332, 333, 347, 348, 349, 350, 342, 398, 397, 401, 400, 399, 356, 354, 368, 374,
    357, 379, 371, 370, 369, 358, 363, 359, 385, 373, 388, 387, 386, 396, 390, 362, 389,
    391, 392, 423, 415, 428, 438, 421, 433, 432, 427, 410, 417, 416, 420, 429, 424, 471,
    443, 444, 440, 598, 441, 483, 481, 482, 408, 402, 405, 411, 406, 407, 403, 409, 404,
    446, 515, 447, 448, 449, 450, 451, 452, 454, 455, 456, 457, 458, 459, 460, 461, 462,
    463, 465, 466, 469, 470, 472, 475, 476, 477, 509, 528, 506, 505, 523, 534, 504, 537,
    507, 502, 500, 499, 501, 473, 474, 518, 521, 520, 642, 519, 641, 526, 525, 536, 533,
    557, 543, 468, 552, 553, 571, 555, 556, 577, 559, 620, 558, 579, 570, 599, 575, 635,
    633, 634, 580, 625, 624, 597, 636, 589, 674, 639, 638, 590, 637, 640, 631, 630, 593,
    594, 595, 632, 1089, 645, 621, 644, 623, 587, 588, 627, 648, 649, 659, 667, 656, 661,    
    662, 663, 665, 670, 678, 672, 675, 677, 679, 680, 684, 682, 683, 693, 694, 696, 709,
    695, 707, 723, 951, 704, 710, 717, 705, 718, 708, 720, 719, 712, 724, 725, 726, 727,   
   728, 772, 611, 602, 711, 603, 729, 738, 612, 613, 730, 605, 735, 736, 737, 615, 614,
    607, 606, 745, 762, 739, 760, 608, 604, 756, 763, 764, 765, 752, 750, 755, 754, 609,
    812, 766, 788, 767, 761, 616, 781, 780, 779, 757, 748, 747, 746, 749, 807, 806, 769,
    784, 619, 617, 610, 778, 787, 768, 789, 956, 774, 795, 792, 794, 878, 881, 805, 776,
    777, 773, 618, 796, 798, 831, 791, 830, 1069, 819, 793, 790, 800, 820, 797, 823, 826,  
    822, 818, 815, 817, 821, 839, 877, 829, 833, 834, 832, 825, 931, 840, 845, 857, 849,
    850, 851, 852, 853, 854, 855, 856, 846, 847, 848, 864, 865, 866, 867, 868, 869, 870,
    871, 858, 859, 860, 861, 862, 863, 838, 837, 893, 897, 885, 944, 937, 892, 844, 879,
    880, 875, 904, 876, 886, 936, 896, 888, 889, 890, 894, 895, 938, 887, 915, 898, 899,
    942, 939, 923, 932, 933, 921, 901, 914, 920, 913, 912, 955, 902, 903, 943, 924, 916,
    905, 935, 926, 906, 910, 909, 918, 917, 919, 929, 930, 941, 940, 947, 948, 908, 950,
    960, 954, 957, 958, 962, 963, 966, 967, 975, 969, 971, 972, 999, 973, 974, 1038, 976,
    1010, 1022, 1021, 977, 978, 979, 983, 1008, 1020, 1023, 1015, 988, 1014, 1018, 1003,
    1004, 990, 984, 1009, 996, 1001, 1024, 643, 1039, 985, 1019, 995, 997, 1025, 1026,
    998, 1027, 1028, 1002, 986, 987, 1041, 1029, 989, 1078, 1013, 1037, 426, 1017, 1034,
    1035, 1042, 1033, 1036, 1070, 1083, 1307, 1062, 1080, 1071, 1072, 1087, 1120, 1082,
    1373, 1358, 1094, 1333, 1095, 1363, 1334, 1107, 1359, 1326, 1105, 1106, 1369, 1365,
    1375, 1111, 1112, 1376, 1374, 1297, 1304, 1305;
b) 90, 105, 118, 119, 135, 171, 175, 176, 222, 218, 227, 226, 232, 233, 241, 248, 249,
    256, 261, 262, 276, 277, 282, 303, 302, 316, 313, 304, 311, 312, 320, 327, 334, 333,
    343, 345, 396
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letters dated August 20 and August 23, 2007. 
Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing.
REASON
System Shut Down -- Unexpected Shut Down during use of the Optional Remote Control.
VOLUME OF PRODUCT IN COMMERCE
633 total devices: 37 BV Endura, 596 BV Pulsera
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
SmartSeal Wedge Femoral Pressurizer; Product Code/Catalog No: 3206002. This product allows for effective and controlled pressurization of bone cement into the femur and the acetabulum during hip arthroplasty procedures, Recall #  Z-0176-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopaedics, Inc., Warsaw,  IN, by letter on July 13, 2007 and July 23, 2007.
Manufacturer: Depuy CMW, Blackpool, Lancashire, UK. Firm initiated recall is ongoing.  
REASON
Package Integrity: The outer peelable pouch seals may be compromised due to creasing, although the inner pouch seals are intact.
VOLUME OF PRODUCT IN COMMERCE
3,530 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems, Recall # Z-0181-2008
CODE
Serial numbers: IT35052, IT35070, IT35108, IT35109, IT35129, IT35130, IT35132, IT35133, IT35134, IT35139, IT35146, IT35152, IT35166, IT35169P-RC-1, IT35173, IT35179P, IT35181, IT35185P-G-RC, IT35187P, IT35189P, IT35193P, IT35214P, IT35216P, IT35223P, IT35225P, IT35226P, IT35234P, IT35244P, IT35245P, IT35251P, IT35269P, IT35280P, IT35286P, IT35289P, IT35292P, IT35293P, IT35296P, IT35299P, IT35301P, IT35302P, IT35304P, IT35311P, IT35312P, IT35316P, IT35323P, IT35324P, IT35330P, IT35339P, IT35344P, IT35375P, IT35377P, IT35379P, IT35381P, IT35382P, IT35383P, IT35406G, IT35435G, IT35458G, IT35468G. Two numbers unavailable.
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City UT, by letter dated October 11, 2007. Firm initiated recall is ongoing.
REASON
Tracking Accuracy - Image intensifier supplier's change on the C-Arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.
VOLUME OF PRODUCT IN COMMERCE
61 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Recall # Z-0182-2008
CODE
All codes prior to 07177xx
RECALLING FIRM/MANUFACTURER
Pacific Bioscience Lab, Inc., Bellevue, WA, by press release and its Website on August 30, 2007. Firm initiated recall is ongoing.
REASON
Overheating: The handle or charger/cradle can overheat, melting the plastic, which potentially can lead to smoke and fire and has caused mild user burns.
VOLUME OF PRODUCT IN COMMERCE
101,513 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Product Description : GE OEC, Insta Trak 3500 Plus with the Cranial Application for Image Guided Surgery, Recall # Z-0183-2008
CODE
Not applicable
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter dated October 11, 2007. Firm initiated recall is ongoing.
REASON
Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.
VOLUME OF PRODUCT IN COMMERCE
169 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Stryker T2 Locking Screw, Fully threaded; 05 x 70mm, Catalog Number: 1896-5070S, Sterile, Recall # Z-0214-2008
CODE
Lot: K871252
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 27, 2007.
Manufacturer: Stryker Trauma GmbH, Schonkirchen, Germany. Firm initiated recall is ongoing.
REASON
Mislabeled: One lot of screws (05x70mm) is labeled as containing 70mm, but may actually contain 75mm length screws.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Matrix MAX3 Actuator, Catalog Number : MAX30 A300545A252L0V000,
    Recall # Z-0215-2008;
b) Matrix MAX3 Actuator, Catalog Number: MAX30 A300545A2510V000,  
    Recall # Z-0216-2008;
c) Matrix MAX3 Actuator, Catalog Number: MAX30 A300515A254L000,
    Recall # Z-0217-2008
CODE
a) Serial number L03684171;
b) Serial number 3337328;
c) Serial number 3072047
RECALLING FIRM/MANUFACTURER
Recalling Firm: SKF USA Inc., Norristown, PA, by letter on or about July 24, 2007. 
Manufacturer: Magnetic Elektromotoren, Liestal, Switzerland. Firm initiated recall is ongoing.
REASON
Sudden failure of the actuator during lifting operation.
VOLUME OF PRODUCT IN COMMERCE
1,298 units
DISTRIBUTION
IA, MN, NE, NY, and OH
___________________________________
PRODUCT
a) Stryker Zoom (Atlas) powered patient transport stretcher, Model 660,
     Recall # Z-0219-2008;
b) Stryker Transport wheeled stretcher, Model 720, Recall # Z-0220-2008;
c) Stryker Transport wheeled stretcher, Model 721, Recall # Z-0221-2008;
d) Stryker OEM wheeled stretcher, Model 722, Recall # Z-0222-2008;
e) Stryker Transport wheeled stretcher, Model 735 (ST104), Recall # Z-0223-2008;
f) Stryker Advantage Series Emergency Care wheeled stretcher, Model 1001,
    Recall # Z-0224-2008;
g) Stryker Trauma wheeled stretcher, Model 1002, Recall # Z-0225-2008;
h) Stryker M-Series wheeled stretcher, Model 1005 (SM104), Recall # Z-0226-2008;
i) Stryker Advantage Series Emergency Care wheeled stretcher, Model 1009,
    Recall # Z-0227-2008;
j) Stryker M-Series wheeled stretcher, Model 1015 (SM204), Recall # Z-0228-2008;
k) Stryker Trauma wheeled stretcher, Model 1020, Recall # Z-0229-2008;
l) Stryker M-series powered patient transport stretcher, Model 1025 (SM304),
    Recall # Z-0230-2008;
m) Stryker Eye Surgery (Head/Neck Surgery) wheeled stretcher, Model 1069,
     Recall # Z-0231-2008;
n) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1210,
     Recall # Z-0232-2008;
o) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1211,  
    Recall # Z-0233-2008;
p) Stryker Renaissance Series Emergency Care wheeled stretcher, Model 1231,
     Recall # Z-0234-2008;
q) Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1501,  
    Recall # Z-0235-2008;
r) Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1509,
    Recall # Z-0236-2008;
s) Stryker Renaissance Series PACU wheeled stretcher, Model 1710,
    Recall # Z-0237-2008;
t) Stryker Renaissance Series PACU wheeled stretcher, Model 1711,
     Recall # Z-0238-2008;
u) Stryker Renaissance Series PACU wheeled stretcher, Model 1731,
     Recall # Z-0239-2008
CODE
All stretchers with serial numbers beginning with 0309 through 0505.
RECALLING FIRM/MANUFACTURER
Stryker Medical Div. of Stryker Corporation, Portage MI, by letter dated September 24, 2007. Firm initiated recall is ongoing.
REASON
The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.
VOLUME OF PRODUCT IN COMMERCE
81,367 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Recall # Z-0240-2008
CODE
Serial numbers E322AD0046 through H023AD6179. (E means 2003 production, F means 2004 production, G means 2005 production and H means 2006 production).
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc., Batesville, IN, by letter dated November 12, 2007. Firm initiated recall is ongoing.
REASON
False Latch/Failure to Latch-The side rail may not latch, or the latch may not fully engage, resulting in the side rail being able to be lowered without pulling on the release handle.
VOLUME OF PRODUCT IN COMMERCE
 43,731 beds
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT
a) NEMIO Ultrasound System, Model SSA-550A , Software versions: V3.1.000B,
    V3.5.0, V3.5.000A, V3.5.000B, V3.6.0, V3.6.000A, V4.0.0, V4.0.000A, V4.l.0,
    V4.l.000A, V4.2.0, V4.3.0, V4.5.0, V4.5.000A, Recall $ Z-0253-2008;
b) NEMIO XG Ultrasound System, Model SSA-580A , Software versions: VI .5.0,
    Vl .5.000A, VI .5.000B, V2.0.0, Recall # Z-0254-2008
CODE
a) Serial numbers: C1592849 E2524072 E2524073 E2524074 E2524075 E2524076 E2524077 E2524078 E2524079 E2524080 E2524081 E2524082 E2524083 E2524084 E2524085 E2524086 E2534236 E2534237 E2534238 E2534239 E2534240 E2534241 F2534286 F2534287 F2534288 F2534289 F2534290 F2534291 F2534292 F2544351 F2544352 F2544353 F2544354 F2544355 F2544356 F2544357 F2544358 F2544427 F2544428 F2544429 F2544430 F2544431 F2544432 F2544433 F2544451 F2544452 F2544453 F2544505 F2544506 F2544507 F2544508 F2544509 F2544510 F2544511 F2544512 F2544513 F2544514 F2544515 F2544516 F2544517 F2544518 F2544519 F2544520 F2544521 F2544522 F2544523 F2544524 F2544525 F2544526 F2564733 F2564734 F2564735 F2564736 F2564737 F2564738 F2564739 F2564740 F2564741 F2564742 F2564743 F2564744 H2626535 H2626536 H2626537 H2626538 H2626539 H2626540 H2626541 H3516932 H3516933 H3516934 H3516935 H3516936 H3516937 I3522331 I3522332 I3522333 I3522334 I3522335 I3522336 I3522337 I3522338 I3522339 I3522340 I3522341 I3522342 I3522343 I3522344 I3522345 I3522346 I3522347 I3522348 I3522505 I3522506 I3522507 I3522508 J3542933 J3542934 J3542935 J3542936 J3542937 J3542938 J3542939 J3542940 J3543085 J3543086 J3543087 J3543088 J3543089 J3543090 J3543091 J3543092 J3553299 J3563308 J3563491 J3563492 J3563493 J3573564 J3573565 J3573566 J3573568 J3573569 J3573570 J3573571 J3573755 J3573756 J3573757 J3573759 K3594276 K3594277 K3594278 K3594279 K3594280 K3594281 K3594282 K3594283 K3594284 K3594285 K3594286 K3604572 K3604573 K3604682 K3604683 K3604813 K3604814 K3604815 K3604817 K3615183 K3615184 K3615185 K3625506 K3625507 K3625508 K3625510 K3625622 K3625718 K3625719 K3625720 K3625721 K4516086 K4516207 K4516209 K4516458 K4516459 K4516460 K4516461 K4516462 K4516463 K45226679 K4526678 K4526680 K4526681 K4526682 K4526683 K4526684 K4526685 K4526686 K4526687 K4526862 K4526864 K4532031 K4532032 K4532033 K4532034 K4532035 K4532036 K4532037 K4532038 K4532039 K4532040 K4532041 K4532042 K4532043 K4532044 K4532045 K4532046 K4536951 K4536952 K4536953 K4536954 K4536955 K4536956 K4536957 K4536958 L4542242 L4542244 L4542245 L4542315 L4542316 L4552586 L4552587 L4552588 L4573185 L4573186 L4573187 L4573188 L4573189 L4573391 L4573392 L4573393 L4573394 L4573396 L4583605 L4583766 M4594410 M4594411 M4594543 M4594544 M4604678 M4604841 M4604842 M4604843 M4604844 M4604845 M4615111 M4615112 M4615113 M4615117 M4615118 M4615119 M4615120 M4615307 M4615308 M4625540 M4625541 M4625665 M4625729 M4625730 N5515886 N5515887 N5515941 N5515942 N5515943 N5515944 N5515945 N5515946 N5516094 N5516095 N5516096 N5516097 N5526253 N5526338 N5526339 N5526340 N5526341 N5526342 N5526344 N5526345 N5526477 N5526478 N5526479 N5526480 N5536592 N5536593 N5536594 N5536595 N5536596 N5536597 N5536598 N5536599 N5536600 N5536601 N5536702 N5536703 N5536704 N5536705 N5536810 N5536811 N5536812 N5536813 N5536814 N5536815 N5536816 N5536817 N5536818 N5536819 N5536820 N5536821 N5536822 N5536823 N5536824 N5536825 N5536826 O5542122 O5542123 O5542208 O5542209 O5542210 O5542211 O5542212 O5542213 O5542214 O5542215 O5542216 O5542217 O5542218 O5542219 O5542220 O5542308 O5542309 O5552383 O5552384 O5552385 O5552386 O5552387 P5573253 P5573256 P5573257 P5573258 P5573259 P5593754 P5593755 P5593756 P5593757 P5593758 P5593759 P5593764 P5593765 P5604059 P5604060 P5604061 P5604062 P5604133 P5604134 P5604138 P5604139 P5614513 P5614515 P5614558 P5624681 P5624682 P5624683 P5624684 P5624782 P6576511 P6576512 P6586693 P6586694 P6586742 P6586790 P6596905 P6596906 P6596907 P6596908 P6596954 P6596955 P6602010 P6602011 P6602012 P6602013 P6602069 P6602070 P6602115 P6602116 P6602117 P6602118 P6602119 P6602162 P6602163 P6612218 P6612221 P7533088 P7533089 P7533112 P7533178 B1542260 B1542261 B1542262 B1542263 B1552336 B1552337 B1552338 B1552339 B1552340 B1552341 B1552342 B1552343 B1552344 B1552345 B1552346 B1552348 B1552349 B1552350 C1572408 C1572409 C1572410 C1572411 C1572412 C1572413 C1572414 C1572415 C1572416 C1572417 C1572418 C1572419 C1572420 C1572421 C1572422 C1572423 C1572425 C1572426 C1572427 C1572428 C1572429 C1572430 C1572431 C1572432 C1572433 C1572434 C1572435 C1572436 C1572437 C1572458 C1572459 C1572460 C1572461 C1572462 C1572463 C1572464 C1572465 C1572466 C1572467 C1572468 C1572469 C1572470 C1572471 C1582540 C1582541 C1582543 C1582544 C1582545 C1582546 C1582547 C1582548 C1582550 C1582551 C1582552 C1582578 C1582579 C1582580 C1582581 C1582582 C1582583 C1582584 C1582585 C1582586 C1582587 D1602981 D1602982 D1602983 D1602985 D1602986 D1602987 D1602988 D1602989 D1602990 D1602991 D1602992 D1602993 D1602994 D1602995 D1602996 D1602997 D1613133 D1613134 D1613135 D1613136 D1613137 D1613138 D1613139 D1613140 D1613141 D1613142 D1623336 D1623337 D1623338 D1623339 D1623340 D1623341 D1623342 D1623343 D1623344 D1623345 E2524139 E2524140 E2524141 E2524142 E2524143 E2524144 E2524145 E2524146 E2524148 E2524155 F2554618 F2554619 F2554620 F2554621 F2554622 F2554623 F2554624 F2564672 F2564673 F2564674 F2564675 F2564676 F2564677 F2564697 F2564698 F2564699 G2574883 G2574884 G2574885 G2574886 G2574887 G2574888 G2574889 G2574890 G2574891 G2574892 G2574893 G2574894 G2574895 G2585178 G2585179 G2585180 G2585181 G2585182 G2585183 G2585184 G2585185 G2585196 G2585197 G2585198 G2585199 G2585200 G2585201 G2585202 G2585203 G2585324 H2585516 H2585517 H2585518 H2585519 H2585520 H2585521 H2585522 H2585523 H2605828 H2605829 H2605830 H2605831 H2605832 H2605833 H2605834 H2605835 H2605836 H2605837 H2616223 H2616224 H2616225 H2616226 H2616227 H2616313 H2616314 H2616315 H2616316 H2616317 H2616318 H2616319 H2616320 H2616357 H2616358 H2616359 H2626461 H2626462 H2626463 H2626464 H2626465 H2626466 H2626467 H3516836 H3516837 H3516838 H3516839 H3516840 H3516841 H3516842 H3516843 H3516844 H3516845 H3516846 H3516847 H3516848 H3516849 H3516850 H3516991 H3516992 H3516993 H3516994 H3516995 I3522293 I3522294 I3522295 I3522296 I3522297 I3522298 I3522299 J3542925 J3542926 J3542927 J3542928 J3542929 J3543008 J3543009 J3543010 J3543012 J3543018 J3543019 J3543020 J3543021 J3553153 J3553154 J3553155 J3553234 J3553235 J3553236 J3573529 J3573721 J3573722 J3573723 J3573724 J3583864 J3583865 J3583866 J3583867 J3583868 J3583869 J3583870 J3583871 J3583872 J3583873 J3594187 K3594186 K3604635 K3604636 K3604637 K3604638 K3604639 K3604640 K3604641 K3604642 K3604645 K3604646 K3604647 K3604648 K3615095 K3615096 K3615100 K3615101 K3615102 K3615103 K3615104 K3615105 K3615106 K3615107 K3615108 K3615109 K3615110 K3615111 K3615112 K3615113 K3615114 K3615115 K3615116 K3615117 K3615118 K3615119 K3615120 K3615121 K3615123 K3625433 K3625434 K3625435 K3625436 K3625437 K3625444 K3625446 K3625447 K3625448 K3625450 K3625451 K3625452 K3625453 K3625454 K3625455 K3625456 K3625457 K3625654 K3625655 K3625656 K3625657 K3625658 K4516171 K4516173 K4516175 K4516177 K4516178 K4516180 K4516182 K4516183 K4516184 K4516185 K4516186 K4516188 K4516189 K4516388 K4516389 K4516391 K4516395 K4526793 K4526795 K4526796 K4526797 K4526798 K4526799 K4526800 K4532067 K4532068 K4532069 K4532070 K4532071 K4532072 K4532073 K4532074 K4532075 K4536911 K4536912 K4536913 K4536915 K4536917 K4536918 L4532118 L4542273 L4542398 L4542400 L4542402 L4542403 L4552683 L4552684 L4562757 L4562758 L4562759 L4562760 L4562761 L4562762 L4562849 L4562850 L4562925 L4563013 L4563014 L4563016 L4573115 M4594495 M4604596 M4604597 M4604701 M4604702 M4604703 M4604704 M4604705 M4604706 M4604707 M4614981 M4614982 M4614984 M4614985 M4615047 M4615050 M4615051 M4615052 M4615054 M4615055 M4615059 M4615060 M4615061 M4615062 M4615063 M4615064 M4615065 M4615066 M4615067 M4615169 M4615170 M4615171 M4615172 M4615173 M4615174 M4615278 M4615348 M4615349 M4615350 M4615351 M4615352 M4615353 M4615354 M4615355 M4615356 M4625402 M4625403 M4625404 M4625476 M4625477 M4625479 M4625480 M4625481 M4625482 M4625484 M4625485 M4625487 M4625488 M4625490 M4625493 M4625494 M4625495 M4625496 M4625497 M4625498 M4625499 M4625500 M4625501 M4625502 M4625503 M4625504 M4625505 M4625592 M4625593 M4625594 M4625595 M4625597 M4625598 M4625599 M4625600 M4625601 M4625602 M4625603 M4625604 M4625605 M4625606 M4625607 M4625613 M4625614 M4625615 M4625616 M4625617 N5515775 N5515786 N5515787 N5515788 N5515790 N5515792 N5515793 N5515794 N5515796 N5515799 N5515852 N5515853 N5515855 N5515856 N5516031 N5526138 N5526139 N5526140 N5526141 N5526142 N5526143 N5526144 N5526278 N5526279 N5526280 N5526281 N5526282 N5526283 N5526284 N5526379 N5526380 N5526381 N5526382 N5526383 N5526384 N5526385 N5536560 N5536561 N5536562 N5536563 N5536564 N5536565 N5536566 N5536567 N5536568 N5536569 N5536616 N5536617 N5536618 N5536619 N5536620 N5536621 N5536622 N5536623 N5536624 N5536625 N5536636 N5536637 N5536638 N5536639 N5536640 N5536641 N5536642 N5536643 N5536644 N5536645 N5536766 O5542018 O5542020 O5542021 O5542022 O5542025 O5542026 O5542027 O5542028 O5542030 O5542032 O5542033 O5542034 O5542035 O5542037 O5542038 O5542040 O5542041 O5542042 O5542154 O5542155 O5542158 O5542159 O5542160 O5542161 O5542162 O5542165 O5542166 O5542167 O5542170 O5542171 O5542260 O5542268 O5542269 O5542270 O5542271 O5542272 O5542273 O5542274 O5542321 O5552431 O5552432 O5552433 O5552434 O5552435 O5552436 O5552437 O5552493 O5552494 O5572855 O5572856 O5572857 O5572858 O5572859 O5572860 O5572861 O5572862 O5572863 O5572864 P5573154 P5573155 P5573160 P5573161 P5573162 P5573163 P5573165 P5573166 P5573212 P5573262 P5583288 P5583289 P5583290 P5583565 P5593628 P5593629 P5593630 P5593631 P5593632 P5593633 P5593634 P5593635 P5593636 P5593637 P5593684 P5593685 P5593686 P5593687 P5593688 P5593689 P5593690 P5593691 P5593785 P5593786 P5593787 P5593788 P5593789 P5593790 P5593791 P5593792 P5593793 P5593794 P5593795 P5593796 P5593797 P5593798 P5593799 P5593800 P5593801 P5603876 P5603963 P5603970 P5603972 P5604085 P5604086 P5604087 P5604088 P5604089 P5604090 P5604091 P5604176 P5614296 P5614297 P5614298 P5614302 P5614303 P5614305 P5614306 P5614307 P5614308 P5614309 P5614441 P5614491 P5614492 P5614493 P5614494 P5614495 P5614496 P5614497 P5614498 P5614499 P5614500 P5624564 P5624565 P5624722 P5624723 P5624724 P5624725 P5624727 P5624728 P5624729 P5624730 P5624731 P5624732 P5624733 P5624734 P5624735 P5624736 P5624738 P5624823 P5624824 P5624825 P5624826 P5624827 P5624890 P5624891 P5624892 P5624893 P5624894 P6514922 P6514923 P6514924 P6514925 P6514926 P6514927 P6514928 P6514929 P6514930 P6514931 P6514932 P6514933 P6514934 P6514935 P6514936 P6514937 P6515051 P6515054 P6515055 P6515056 P6515150 P6515151 P6515152 P6515153 P6515154 P6515155 P6515156 P6515157 P6515232 P6515233 P6515239 P6515244 P6515246 P6515248 P6525289 P6525290 P6525291 P6525292 P6525294 P6525295 P6525296 P6525297 P6525299 P6525300 P6525301 P6525302 P6525303 P6525304 P6525305 P6525306 P6525307 P6525308 P6525380 P6525381 P6525382 P6525383 P6525384 P6525385 P6525386 P6525387 P6525388 P6525389 P6525390 P6525391 P6525392 P6525393 P6525394 P6525395 P6525476 P6525480 P6525481 P6525482 P6525483 P6525484 P6525485 P6525486 P6525487 P6525488 P6525489 P6525490 P6525491 P6525492 P6525493 P6525573 P6525574 P6525575 P6525576 P6525577 P6525578 P6525628 P6525629 P6525630 P6525631 P6525632 P6525633 P6525634 P6525635 P6535646 P6535647 P6535648 P6535649 P6535707 P6535708 P6535714 P6535715 P6535716 P6535717 P6535789 P6535790 P6535791 P6535825 P6546115 P6546116 P6566446 P6576489 P6576490 P6576491 P6576492 P6576493 P6576494 P6576495 P6586670 P6586671 P6586672 P6586673 P6586674 P6586675 P6586676 P6586677 P6586770 P6586771 P6596882 P6596883 P6596884 P6596933 P6596934 P6596935 P6596936 P6602035 P6602036 P6602037 P6602038 P6602139 P6602140 P6606990 P6612181 P6612182 P6622412 P6622413 P7522984;

b) Serial numbers: A1A0642100 A1A0642102 A1B0662183 A1B0662184 A1B0662256 A1B0662257 A1B0662258 A1B0662327 A1B0662328 A1B0662330 A1B0662331 A1C06Z3155 A1C0713291 A1C0713292 A1C0713293 A1C0713294 A1C0713295 A1C0713296 A1C0713297 A1C0713298 A1C0713299 A1C0713300 A1C0713301 A1C0713379 A1C0723418 A1C0723419 A1C0723420 A1C0723540 A1C0723541 A1C0733580 A1C0733581 A1C0733610 A3A0652115 A3B0662284 A3B0662285 A3B0662286 A3B0662287 A3B0662288 A3B0662289 A3B0662290 A3B0662291 A3B0662292 A3B0662293 A3B0662371 A3B0662372 A3B0662373 A3B0662374 A3B0662375 A3B0662376 A3B0662377 A3B0662378 A3B0662379 A3B0662380 A3B0672415 A3B0672416 A3B0672417 A3B0672418 A3B0672419 A3C06Y3027 A3C06Z3065 A3C06Z3066 A3C06Z3067 A3C06Z3105 A3C06Z3106 A3C06Z3107 A3C06Z3108 A3C06Z3109 A3C06Z3110 A3C06Z3111 A3C0713345 A3C0713346 A3C0713347 A3C0713348 A3C0713349 A3C0713350 A3C0713351 A3C0723457 A3C0723458 A3C0723459 A3C0723460 A3C0723461 A3C0723462 A3C0723463 A3C0723464 A3C0723511 A3C0723512 A3C0723513 A3C0723514 A3C0723515 A3C0723516 A3C0723517 A3C0723518 A3C0723519 A3C0723520 A3C0723521 A3C0723522 A3C0723523 A3C0723524 A3C0723525 A3C0723526 A3C0723527 A3C0723528 A3C0723548 A3C0723549 A3C0723551 A3C0723552 A3C0723553 A3C0733572 A3C0733573 A3C0733574 A3C0733576 A3C0733577 A3C0733713 A3C0733714 A3C0733715 A3C0733716 A3C0733717 A3C0733718 A3C0733721 A3C0733722 A3C0733723 A3C0733724 A3C0733725 A3C0733727 A3C0733728 A3C0733729 A3C0733731 A3C0733732
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc., Tustin, CA, by letters on August 29, 2007.
Manufacturer: Matsushita Electric Industrial Co., Ltd. - Med. Sys. Division, Yokohama City, Kanagawa, Japan. Firm initiated recall is ongoing.
REASON
Multiple problems including: (1) The surface temperature of the transducer tip can rise and exceed the limit set by the international standard. (2) Incorrect display of the TI indices on the display monitor. The displayed value is greater or smaller than the true TI value, and (3) Manuals contain incorrect values for MI/TI values.
VOLUME OF PRODUCT IN COMMERCE
1,406 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR NOVEMBER 21, 2007

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