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U.S. Department of Health and Human Services

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Enforcement Report for March 7, 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.

March 7, 2007
07-10

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

___________________________________
PRODUCT
Tan Tan Tofu Panda Flavor Soybean Juice in 64 fluid ounce opaque plastic containers ***Best if used within 3-5 days of opening***, Recall # F-130-7
CODE
All lots, there are no lot numbers or expiration dates on the product label.
RECALLING FIRM/MANUFACTURER
Tan Tan Tofu, Westminster, CA, by press release and telephone on December 29, 2006. Firm initiated recall is ongoing.
REASON
Product contains undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
720
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

___________________________________
PRODUCT
Garden Greens GojiSplash Goji Berry juice drink active polysaccharaide, Super antioxidants, helps support youth and vitality. Dietary supplement 30 servings/30 fl oz. (900 mL) plastic bottle, TC# A5821002, item N6004, UPC 3504606004, Recall # F-129-7
CODE
All lots that fail to declare sulfites as an ingredient.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Windmill, West Caldwell, NJ, by letter beginning on January 3, 2007.
Manufacturer: Celmark Hydroceuticals, Orlando, FL. Firm initiated recall is ongoing.
REASON
Undeclared sulfites at a level of 10.8 ppm were found during product testing.
VOLUME OF PRODUCT IN COMMERCE
39,836 bottles, 30 fl oz. each
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

****CORRECTION****
Corrections for Recall # B-0117-07 - In the February 21, 2007, (07-08) Enforcement Report.

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0117-07
CODE
Unit: 5776159
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc. New York, NY, by telephone on September 24, 2003 and by letter dated January 6, 2005. Firm initiated recall is complete.
REASON
Platelets, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0805-07;
b) Platelets, Recall # B-0806-07;
c) Recovered Plasma, Recall # B-0807-07
CODE
a) Units: 4759943, 4677574, 4555912;
b) Units: 4759943, 4555912;
c) Units: 4677574, 4555912
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on May 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
MA, OK, TX, and Switzerland

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0808-07;
b) Platelets, Recall # B-0809-07;
c) Recovered Plasma, Recall # B-0810-07
CODE
a), b), and c) Unit: 5249546
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on August 1, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OK, NB, and Switzerland

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0811-07;
b) Recovered Plasma, Recall # B-0812-07
CODE
a) and b) Unit: 5218775
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N, Goldman Center, Oklahoma City, OK, by facsimile on July 7, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OK and Switzerland

___________________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Recall # B-0815-07
CODE
Unit: J41312
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated April 5, 2006. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0819-07;
b) Fresh Frozen Plasma, Recall # B-0820-07
CODE
Unit: 2157929
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New Brunswick, NJ, by facsimile on December 12, 2005 or by letter dated December 12, 2005.
REASON
Blood products, collected from a donor who had a non-confidential health history screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0826-07;
b) Platelets, Recall # B-0827-07;
c) Fresh Frozen Blood, Recall # B-0828-07;
d) Recovered Plasma, Recall # B-0829-07
CODE
a) Units: 5250527, 4901850, 4517058;
b) Units: 4901850, 4517058;
c) Unit: 4517058;
d) Units: 5250527, 4901850
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on March 27, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
OK, TX, Austria, and Switzerland

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0843-07;
b) Recovered Plasma, Recall # B-0844-07
CODE
a) and b) Units: 5738052, 5275313, 4801421
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK, by facsimile on January 22, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX, OK, and Switzerland

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Recall # B-0105-07
CODE
Unit: 53LP55010
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Baltimore, MD, by telephone on February 9, 2006 and by letter dated February 10, 2006. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Maryland

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

___________________________________
PRODUCT
One Touch Basic/Profile and One Touch Ultra-Blood Glucose Test strips- 50-count, Recall # Z-0547-2007
CODE
One Touch Ultra Test Strips: Lot #’s: 2691191, 2691261. One Touch Ultra Basic/Profile Test Strips- Lot #''s 272894A, 2619932, 2606340, 2651211
RECALLING FIRM/MANUFACTURER
Safety & Supplies Co, Inc, East Brunswick, NJ, by letter on February 2, 2007. Firm initiated recall is ongoing.
REASON
Counterfeit product (manufacturer unknown)
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

___________________________________
PRODUCT
Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401); Part 01-15407, Recall # Z-0521-2007
CODE
Lots: G4C00F72HN, G5H00F72HN, G7T00F72HN, G8W00F72HN and G9700F72HN
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Leibinger USA, Portage MI, by letter dated December 22, 2006.
Manufacturer: Stryker Leibinger Gmbh, Freiburg, Germany. Firm initiated recall is ongoing.
REASON
Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component, Knee prosthesis. Catalog number: 204-11-13, Recall # Z-0522-2007
CODE
Serial numbers: 0900529-0900532
RECALLING FIRM/MANUFACTURER
Exactech, Inc., Gainesville, FL, by letter dated December 8, 2006. Firm initiated recall is ongoing.
REASON
The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY
______________________________
PRODUCT
Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor, Recall # Z-0523-2007
CODE
Serial numbers: 1496-004112, 1496-005720, 1496-004094, 1496-004088, 1496-004089, 1496-004090, 1496-004091, 1496-004092, 1496-004093, 1496-004110, 1496-011601, 1496-004111, 1496-010974, 1496-010975, 1496-010977, 1496-011021, 1496-004174, 1496-004175, 1496-004177, 1496-004178, 1496-004179, 1496-004180, 1496-004165, 1496-004166, 1496-009201, 1496-006236, 1496-006432, 1496-006434, 1496-008163, 1496-008164, 1496-005413, 1496-011026, 1496-006435, 1496-006436, 1496-006829, 1496-006830, 1496-006831, 1496-006832, 1496-006895, 1496-006912, 1496-006913, 1496-006914, 1496-009137, 1496-009138, 1496-004108, 1496-004109, 1496-005761, 1496-008497, 1496-008498, 1496-008499, 1496-008500, 1496-008501, 1496-010056, 1496-010057, 1496-005369, 1496-005388, 1496-005412, 1496-010607, 1496-010053, 1496-005254, 1496-005255, 1496-005256, 1496-005257, 1496-005258, 1496-005326, 1496-005327, 1496-005328, 1496-005329, 1496-004075, 1496-004076, 1496-004077, 1496-004078, 1496-004079, 1496-004080, 1496-004081, 1496-004082, 1496-004083, 1496-004084, 1496-004085, 1496-004095, 1496-004096, 1496-004097, 1496-004098, 1496-004099, 1496-004100, 1496-004101, 1496-004102, 1496-004103, 1496-004104, 1496-005340, 1496-005361, 1496-005363, 1496-005364, 1496-005365, 1496-010479, 1496-010480, 1496-010482, 1496-010483, 1496-010485, 1496-010486, 1496-010487, 1496-010488, 1496-010489, 1496-010592, 1496-010595, 1496-010602, 1496-010603, 1496-010604, 1496-010605, 1496-010606, 1496-010608, 1496-010609, 1496-010620, 1496-010621, 1496-010623, 1496-010624, 1496-010625, 1496-010627, 1496-010628, 1496-010778, 1496-010819, 1496-010821, 1496-010822, 1496-010823, 1496-010824, 1496-010825, 1496-010826, 1496-010827, 1496-010828, 1496-010829, 1496-010830, 1496-010831, 1496-010832, 1496-010833, 1496-010835, 1496-010836, 1496-010837, 1496-010838, 1496-010839, 1496-010840, 1496-010841, 1496-010842, 1496-010843, 1496-010844, 1496-010845, 1496-010870, 1496-010871, 1496-010872, 1496-010874, 1496-010876, 1496-010877, 1496-010879, 1496-010834, 1496-010846, 1496-010847, 1496-010848, 1496-010849, 1496-010850, 1496-010851, 1496-010852, 1496-010853, 1496-010854, 1496-010855, 1496-010856, 1496-010857, 1496-010858, 1496-010859, 1496-010860, 1496-010861, 1496-010862, 1496-010863, 1496-010864, 1496-010865, 1496-010866, 1496-010867, 1496-010868, 1496-010869, 1496-010094, 1496-010095, 1496-010120, 1496-010121, 1496-010122, 1496-010123, 1496-010124, 1496-010125, 1496-010126, 1496-010127, 1496-010128, 1496-010129, 1496-010130, 1496-010131, 1496-010132, 1496-010133, 1496-010134, 1496-010135, 1496-010136, 1496-010137, 1496-010138, 1496-010466, 1496-010467, 1496-010468, 1496-009114, 1496-009115, 1496-009116, 1496-009117, 1496-009118, 1496-009119, 1496-009120, 1496-009121, 1496-009122, 1496-009123, 1496-009124, 1496-009125, 1496-009126, 1496-009127, 1496-009128, 1496-009129, 1496-009130, 1496-009131, 1496-009132, 1496-009133, 1496-009134, 1496-009143, 1496-009144, 1496-009145, 1496-009146, 1496-009147, 1496-009148, 1496-009149, 1496-009150, 1496-009151, 1496-009152, 1496-009153, 1496-009154, 1496-009155, 1496-009156, 1496-009157, 1496-009158, 1496-009159, 1496-009160, 1496-009161, 1496-009162, 1496-009163, 1496-009164, 1496-009165, 1496-009166, 1496-009167, 1496-009168, 1496-009169, 1496-009170, 1496-009171, 1496-009172, 1496-009173, 1496-009174, 1496-009175, 1496-009176, 1496-009177, 1496-009178, 1496-009179, 1496-009180, 1496-009181, 1496-009182, 1496-009183, 1496-009184, 1496-009186, 1496-009187, 1496-009188, 1496-009189, 1496-009190, 1496-009191, 1496-009192, 1496-009193, 1496-009194, 1496-009195, 1496-009196, 1496-009197, 1496-009198, 1496-009199, 1496-009200, 1496-009207, 1496-009208, 1496-009209, 1496-009210, 1496-009211, 1496-009212, 1496-009213, 1496-009214, 1496-009215, 1496-009216, 1496-009217, 1496-009218, 1496-009219, 1496-009220, 1496-009221, 1496-009222, 1496-009223, 1496-009224, 1496-009225, 1496-009226, 1496-009227, 1496-009228, 1496-009229, 1496-009230, 1496-009231, 1496-009232, 1496-009233, 1496-009234, 1496-009235, 1496-009236, 1496-009237, 1496-009238, 1496-009239, 1496-009240, 1496-009241, 1496-009242, 1496-009243, 1496-009244, 1496-009245, 1496-009246, 1496-009247, 1496-009248, 1496-009249, 1496-009250, 1496-009251, 1496-009252, 1496-009253, 1496-009254, 1496-009255, 1496-009256, 1496-009257, 1496-009258, 1496-009260, 1496-009261, 1496-009262, 1496-009263, 1496-009264, 1496-009908, 1496-009909, 1496-010054, 1496-010055, 1496-010484, 1496-010610, 1496-010611, 1496-010622, 1496-010878, 1496-010880, 1496-010881, 1496-010882, 1496-010883, 1496-010884, 1496-010885, 1496-010886, 1496-010887, 1496-010888, 1496-010889, 1496-010890, 1496-010912, 1496-010970, 1496-010976, 1496-011027, 1496-011440, 1496-011452, 1496-011455, 1496-011459, 1496-011464, 1496-011469, 1496-011470, 1496-011471, 1496-011472, 1496-011473, 1496-011474, 1496-011475, 1496-011476, 1496-011477, 1496-011478, 1496-011479, 1496-011602, 1496-011603, 1496-011604, 1496-011605, 1496-011606, 1496-011607, 1496-011608, 1496-011609, 1496-011610, 1496-011611, 1496-011612, 1496-011613, 1496-011614, 1496-011615, 1496-011616, 1496-011626, 1496-011627, 1496-011628, 1496-011629, 1496-011630, 1496-011631, 1496-011632, 1496-011633, 1496-011634, 1496-011636, 1496-011637, 1496-011638, 1496-011639, 1496-011640, 1496-011641, 1496-009204, 1496-009205, 1496-009206, 1496-007416, 1496-010469, 1496-010470, 1496-010471, 1496-010472, 1496-010473, 1496-010474, 1496-010475, 1496-010476, 1496-010477, 1496-010478, 1496-004807, 1496-004808, 1496-006833, 1496-006896, 1496-006910, 1496-006911, 1496-006915, 1496-006916, 1496-007279, 1496-007280, 1496-007308, 1496-007309, 1496-007310, 1496-007311, 1496-007312, 1496-007313, 1496-007648, 1496-007767, 1496-007768, 1496-007769, 1496-007770, 1496-007771, 1496-007772, 1496-007779, 1496-007780, 1496-007781, 1496-009891, 1496-009892, 1496-009893, 1496-009894, 1496-009895, 1496-009898, 1496-009899, 1496-009900, 1496-005366, 1496-005367, 1496-005368, 1496-005370, 1496-005371, 1496-005372, 1496-005373, 1496-005374, 1496-005375, 1496-005376, 1496-005377, 1496-005378, 1496-005379, 1496-005380, 1496-005381, 1496-005382, 1496-005383, 1496-005384, 1496-005385, 1496-005386, 1496-005387, 1496-006957, 1496-006958, 1496-006967, 1496-006968, 1496-006969, 1496-006970, 1496-006971, 1496-006972, 1496-006973, 1496-006981, 1496-007630, 1496-007631, 1496-007632, 1496-007633, 1496-007744, 1496-007745, 1496-007746, 1496-007747, 1496-007748, 1496-007749, 1496-007750, 1496-007751, 1496-007752, 1496-007753, 1496-007754, 1496-007755, 1496-007756, 1496-007757, 1496-008503, 1496-008504, 1496-008580, 1496-008581, 1496-008582, 1496-008583, 1496-008584, 1496-008585, 1496-008586, 1496-008587, 1496-009847, 1496-009854, 1496-009855, 1496-009856, 1496-009857, 1496-009858, 1496-009859, 1496-009860, 1496-009861, 1496-009862, 1496-009863, 1496-009864, 1496-009865, 1496-009866, 1496-009867, 1496-009868, 1496-009869, 1496-009870, 1496-009871, 1496-009872, 1496-009873, 1496-009874, 1496-009875, 1496-009877, 1496-009878, 1496-009879, 1496-009880, 1496-009882, 1496-009883, 1496-009885, 1496-009886, 1496-009887, 1496-009888, 1496-009889, 1496-009890, 1496-010093, 1496-010891, 1496-010892, 1496-010893, 1496-010894, 1496-010895, 1496-010896, 1496-010898, 1496-010899, 1496-010900, 1496-010901, 1496-010902, 1496-010903, 1496-010904, 1496-010905, 1496-010907, 1496-010909, 1496-010910, 1496-010911, 1496-010913, 1496-010971, 1496-010972, 1496-010973, 1496-009135, 1496-009136, 1496-008636, 1496-008637, 1496-007907, 1496-007908, 1496-007909, 1496-007910, 1496-008166, 1496-008167, 1496-008168, 1496-008495, 1496-008496, 1496-006878, 1496-006879, 1496-006880, 1496-006881, 1496-007859, 1496-007860, 1496-007861, 1496-007862, 1496-004086, 1496-004087, 1496-004124, 1496-004125, 1496-004126, 1496-004127, 1496-004128, 1496-004129, 1496-004130, 1496-004131, 1496-004132, 1496-004133, 1496-004134, 1496-004135, 1496-004136, 1496-004137, 1496-004138, 1496-004139, 1496-004140, 1496-004141, 1496-004142, 1496-004143, 1496-004144, 1496-004145, 1496-004146, 1496-004147, 1496-004148, 1496-004149, 1496-004150, 1496-004151, 1496-004152, 1496-004153, 1496-004154, 1496-004155, 1496-004156, 1496-004157, 1496-004158, 1496-004167, 1496-004168, 1496-004169, 1496-005124, 1496-006543, 1496-009141, 1496-009142, 1496-006876, 1496-006877, 1496-007133, 1496-007140, 1496-007142, 1496-007143, 1496-007145, 1496-007212, 1496-007628, 1496-007629, 1496-008165, 1496-010049, 1496-010050, 1496-004105, 1496-004106, 1496-004107, 1496-004121, 1496-004122, 1496-004123, 1496-004159, 1496-004160, 1496-004161, 1496-004162, 1496-004163, 1496-004164, 1496-004181, 1496-005125, 1496-005126, 1496-005127, 1496-005128, 1496-005129, 1496-005130, 1496-005131, 1496-005132, 1496-005133, 1496-005226, 1496-005227, 1496-005228, 1496-005229, 1496-005230, 1496-005231, 1496-008502, 1496-008588, 1496-008608, 1496-008625, 1496-008626, 1496-008627, 1496-008628, 1496-008629, 1496-008630, 1496-008635, 1496-009259, 1496-009265, 1496-009266, 1496-009267, 1496-009268, 1496-009269, 1496-009270, 1496-009271, 1496-009831, 1496-009832, 1496-009833, 1496-009834, 1496-009835, 1496-009836, 1496-009837, 1496-009838, 1496-009839, 1496-009840, 1496-009841, 1496-009842, 1496-009843, 1496-009844, 1496-009845, 1496-009846, 1496-009848, 1496-009849, 1496-009850, 1496-009851, 1496-009852, 1496-009853, 1496-009881, 1496-009911, 1496-009912, 1496-009913, 1496-009914, 1496-009915, 1496-009916, 1496-009917, 1496-009918, 1496-009919, 1496-009920, 1496-009921, 1496-009922, 1496-004809, 1496-004810, 1496-004811, 1496-004812, 1496-004113, 1496-004114, 1496-004115, 1496-004116, 1496-004804, 1496-005330, 1496-005331, 1496-005332, 1496-005333, 1496-005334, 1496-005335, 1496-005336, 1496-005337, 1496-005338, 1496-005339, 1496-006204, 1496-006205, 1496-006206, 1496-006207, 1496-006208, 1496-006209, 1496-006210, 1496-006211, 1496-006212, 1496-006213, 1496-006214, 1496-006215, 1496-006216, 1496-006217, 1496-006218, 1496-006219, 1496-006220, 1496-006221, 1496-006222, 1496-006223, 1496-006224, 1496-006225, 1496-006226, 1496-006227, 1496-006228, 1496-006229, 1496-006230, 1496-006231, 1496-006232, 1496-006233, 1496-006234, 1496-006235, 1496-006237, 1496-006238, 1496-006239, 1496-006240, 1496-006241, 1496-006882, 1496-006883, 1496-006897, 1496-006898, 1496-006899, 1496-006900, 1496-006906, 1496-006907, 1496-006908, 1496-008638, 1496-008639, 1496-008640, 1496-008641, 1496-008642, 1496-008643, 1496-008644, 1496-008645, 1496-008646, 1496-008647, 1496-008648, 1496-008649, 1496-008650, 1496-008651, 1496-008652, 1496-008653, 1496-008654, 1496-008655, 1496-008656, 1496-008657, 1496-008658, 1496-008659, 1496-008660, 1496-008661, 1496-008662, 1496-008663, 1496-008664, 1496-008665, 1496-009079, 1496-009080, 1496-009081, 1496-009082, 1496-009083, 1496-009084, 1496-009085, 1496-009086, 1496-009087, 1496-009088, 1496-009089, 1496-009090, 1496-009091, 1496-009092, 1496-009093, 1496-009094, 1496-010058, 1496-010059, 1496-010060, 1496-010086, 1496-010087, 1496-010088, 1496-010089, 1496-010090, 1496-010091, 1496-010092, 1496-005414, 1496-005415, 1496-005416, 1496-005702, 1496-005703, 1496-005704, 1496-005705, 1496-005706, 1496-005707, 1496-005708, 1496-005709, 1496-005710, 1496-005711, 1496-005712, 1496-005713, 1496-005714, 1496-005715, 1496-005716, 1496-005717, 1496-005718, 1496-005719, 1496-005721, 1496-005722, 1496-005723, 1496-005724, 1496-005725, 1496-005726, 1496-005727, 1496-005728, 1496-005729, 1496-005730, 1496-005731, 1496-005732, 1496-005733, 1496-005734, 1496-005735, 1496-005736, 1496-005737, 1496-005738, 1496-005739, 1496-005740, 1496-005741, 1496-005742, 1496-005743, 1496-005744, 1496-005745, 1496-005746, 1496-005747, 1496-005748, 1496-005749, 1496-005750, 1496-005751, 1496-005752, 1496-005753, 1496-005754, 1496-005755, 1496-005756, 1496-005757, 1496-005758, 1496-005759, 1496-005760, 1496-005977, 1496-006111, 1496-006112, 1496-006113, 1496-008589, 1496-008590, 1496-008591, 1496-008592, 1496-008593, 1496-008594, 1496-008595, 1496-008596, 1496-008597, 1496-008598, 1496-008599, 1496-008600, 1496-008601, 1496-008602, 1496-008603, 1496-008604, 1496-008605, 1496-008606, 1496-008607, 1496-008609, 1496-008611, 1496-008612, 1496-008613, 1496-008614, 1496-008615, 1496-008616, 1496-008617, 1496-008618, 1496-008619, 1496-008620, 1496-008621, 1496-008622, 1496-008623, 1496-008624, 1496-009095, 1496-009096, 1496-009097, 1496-009098, 1496-009099, 1496-009100, 1496-009101, 1496-009102, 1496-009103, 1496-009104, 1496-009105, 1496-009106, 1496-009107, 1496-009108, 1496-009109, 1496-009110, 1496-009111, 1496-009112, 1496-009113, 1496-009202, 1496-009203, 1496-009884, 1496-010906, 1496-010908, 1496-007411, 1496-007412, 1496-007413, 1496-007414, 1496-007415, 1496-007417, 1496-007461, 1496-007475, 1496-006828, 1496-006885, 1496-006886, 1496-006887, 1496-006888, 1496-006889, 1496-006890, 1496-006891, 1496-006892, 1496-006893, 1496-004117, 1496-004118, 1496-007458, 1496-007459, 1496-007460, 1496-007869, 1496-007870, 1496-007905, 1496-009876, 1496-009901, 1496-009902, 1496-009903, 1496-009904, 1496-009905, 1496-009906, 1496-009907, 1496-009910, 1496-006974, 1496-006975, 1496-006976, 1496-006977, 1496-006978, 1496-006979, 1496-006980, 1496-007123, 1496-007124, 1496-007125, 1496-007126, 1496-007127, 1496-007128, 1496-007129, 1496-007130, 1496-007131, 1496-007134, 1496-007135, 1496-007136, 1496-007138, 1496-007139, 1496-010490, 1496-010491, 1496-010492, 1496-010493, 1496-010494, 1496-010495, 1496-010496, 1496-010513, 1496-010516, 1496-010517, 1496-010518, 1496-010519, 1496-010593, 1496-010594, 1496-010596, 1496-010897, 1496-011022, 1496-011023, 1496-011024, 1496-011025, 1496-005762, 1496-005976, 1496-005978, 1496-005979, 1496-005980, 1496-005982, 1496-005983, 1496-005984, 1496-005985, 1496-005986, 1496-005987, 1496-005988, 1496-005989, 1496-005990, 1496-005991, 1496-005992, 1496-005993, 1496-005994, 1496-005995, 1496-005997, 1496-008129, 1496-008161, 1496-008162, 1496-007906, 1496-008249, 1496-008250, 1496-009139, 1496-009140, 1496-009363, 1496-009364, 1496-009365, 1496-009366, 1496-009185, 1496-004779, 1496-004780, 1496-004781, 1496-004782, 1496-004783, 1496-004784, 1496-004785, 1496-006526, 1496-006527, 1496-006528, 1496-006529, 1496-006530, 1496-006546, 1496-006547, 1496-006548, 1496-006549, 1496-006550, 1496-004176, 1496-005018, 1496-007819, 1496-007820, 1496-007821, 1496-007822, 1496-007823, 1496-007858, 1496-007863, 1496-007864, 1496-007865, 1496-007866, 1496-004170, 1496-004171, 1496-005185, 1496-006433, 1496-006524, 1496-006917, 1496-006918, 1496-006919, 1496-006920, 1496-006921, 1496-006922, 1496-007682, 1496-007696, 1496-008631, 1496-008632, 1496-008633, 1496-008634, 1496-011437, 1496-005014, 1496-005015, 1496-006545, 1496-007213, 1496-007214, 1496-007215, 1496-007216, 1496-007217, 1496-007218, 1496-007219, 1496-007220, 1496-007221, 1496-007222, 1496-007223, 1496-007224, 1496-007225, 1496-007263, 1496-007264, 1496-007265, 1496-007266, 1496-007267, 1496-007269, 1496-007270, 1496-007271, 1496-007272, 1496-007273, 1496-007274, 1496-007275, 1496-007276, 1496-007277, 1496-007278, 1496-007307, 1496-007314, 1496-007315, 1496-007316, 1496-007317, 1496-007410, 1496-007758, 1496-007759, 1496-007760, 1496-007761, 1496-007762, 1496-007763, 1496-007764, 1496-007765, 1496-006821, 1496-006822, 1496-006823, 1496-006824, 1496-006825, 1496-006826, 1496-006827, 1496-006834, 1496-006884, 1496-006894, 1496-006923, 1496-006926, 1496-006927, 1496-006928, 1496-007649, 1496-010051, 1496-010052, 1496-010497, 1496-010498, 1496-010499, 1496-010500, 1496-010501, 1496-010502, 1496-010503, 1496-010504, 1496-010505, 1496-010506, 1496-010507, 1496-010508, 1496-010509, 1496-010510, 1496-010511, 1496-010512, 1496-010514, 1496-010515, 1496-011028, 1496-011029, 1496-011030, 1496-011031, 1496-011032, 1496-011033, 1496-011034, 1496-011035, 1496-011036, 1496-011037, 1496-011038, 1496-011039, 1496-011040, 1496-011041, 1496-011042, 1496-011043, 1496-011044, 1496-011045, 1496-011423, 1496-011424, 1496-011425, 1496-011426, 1496-011427, 1496-011428, 1496-011429, 1496-011430, 1496-011431, 1496-011432, 1496-011433, 1496-011434, 1496-011435, 1496-011436, 1496-011438, 1496-011439, 1496-011441, 1496-011442, 1496-011443, 1496-011444, 1496-011445, 1496-011446, 1496-011447, 1496-011448, 1496-011449, 1496-011450, 1496-011451, 1496-011453, 1496-011454, 1496-011456, 1496-011457, 1496-011458, 1496-011460, 1496-011461, 1496-011462, 1496-011463, 1496-011465, 1496-011466, 1496-011467, 1496-011468, 1496-004805, 1496-004806, 1496-005048, 1496-005049, 1496-005050, 1496-005051, 1496-005052, 1496-005885, 1496-005886, 1496-005887, 1496-005888, 1496-007132, 1496-007137, 1496-007141, 1496-006875, 1496-010626, 1496-010820, 1496-010873, 1496-010875, 1496-007621, 1496-007622, 1496-007623, 1496-007624, 1496-007625, 1496-007626, 1496-007627, 1496-006114, 1496-006115, 1496-004119, 1496-004120, 1496-009896, 1496-009897, 1496-009959, 1496-004183, 1496-004184, 1496-004813, 1496-004814, 1496-004815, 1496-004816, 1496-004817, 1496-004818, 1496-006531, 1496-006532, 1496-006533, 1496-006534, 1496-006535, 1496-006536, 1496-006537, 1496-006538, 1496-006539, 1496-006540, 1496-006541, 1496-006542, 1496-007867, 1496-007868, 1496-009925, 1496-009951, 1496-009952, 1496-010046, 1496-010047, 1496-010048, 1496-010481, 1496-011185, 1496-011186, 1496-011187, 1496-011600, 1496-006116, 1496-006909, 1496-006924, 1496-006925, 1496-006929, 1496-006930, 1496-006931, 1496-006932, 1496-006933, 1496-006934, 1496-006935, 1496-006936, 1496-006937, 1496-006938, 1496-006939, 1496-006940, 1496-006941, 1496-006942, 1496-006943, 1496-006944, 1496-006945, 1496-006946, 1496-006947, 1496-006948, 1496-006949, 1496-006950, 1496-006952, 1496-006953, 1496-006954, 1496-006955, 1496-006956, 1496-009923, 1496-009924
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Incorporated, Issaquah, WA, by letter on January 3, 2007. Firm initiated recall is ongoing.
REASON
Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment.
VOLUME OF PRODUCT IN COMMERCE
1,261 devices
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Biosense Webster PREFACE Guiding Sheath, Multipurpose Short,
for the introduction of intravascular electrophysiology catheters into any
cardiac chamber. Catalog Number 301803MS, Recall # Z-0537-2007;
b) Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm,
for the introduction of intravascular electrophysiology catheters into any
cardiac chamber. Catalog Number 301803M, Recall # Z-0538-2007;
c) Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm,
for the introduction of intravascular electrophysiology catheters into any
cardiac chamber. Catalog Number 301805M, Recall # Z-0539-2007;
d) Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction
of intravascular electrophysiology catheters into any cardiac chamber.
Catalog Number 301803A, Recall # Z-0540-2007;
e) Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction
of intravascular electrophysiology catheters into any cardiac chamber.
Catalog Number 301803P, Recall # Z-0541-2007
CODE
a) Lot numbers: 13070991, 13073870, 13073873, 13080117, 13082797,
13090941, 13099292, 13103566, 13109369, L0103032, L0103066,
L0103069, L0103295, L0105007, L0106017, L0106161, L0106271,
L0203066, L0206045, L0206152, L0206235, L0206249, L0304237,
L0306029, L0306084, L0306161, L0306209, L0404116, L0502384,
L0502568, L0504042, L0602226, L0604089, L0704070, L0804173,
L0902370, L0902618, L0904056, L0904071, L0904089, L0904134,
L0904150, L1002219, L1004025, L1004057, L1004259, L1102088,
L1102219, L1205135 & L1205189;
b) Lot numbers: 13070988, 13070989, 13070990, 13076034, 13076424,
13078567, 13080115, 13080116, 13082796, 13085573, 13085574,
13088352, 13088353, 13091447, 13093420, 13093421, 13096355,
13099291, 13109368, L0104097, L0104215, L0104266, L0105104,
L0105214, L0106131, L0106132, L0106208, L0106234, L0106270,
L0106285, L0204006, L0204061, L0204111, L0204167, L0204238,
L0205091, L0205143, L0205192, L0206043, L0206068, L0206124,
L0206125, L0206151, L0206191, L0206192, L0206218, L0206219,
L0206234, L0304028, L0304057, L0304183, L0304236, L0304299,
L0306043, L0306063, L0306083, L0306110, L0306158, L0306159,
L0306208, L0306283, L0404094, L0404117, L0404178, L0503121,
L0503213, L0504077, L0504275, L0505136, L0505137, L0505220,
L0505268, L0603074, L0603133, L0603177, L0603236, L0604058,
L0604088, L0604144, L0604188, L0604208, L0604209, L0604210,
L0604241, L0605013, L0605214, L0702464, L0704071, L0704146,
L0704226, L0704270, L0704299, L0802069, L0803131, L0804040,
L0804100, L0804171, L0804296, L0805078, L0805118, L0805163,
L0805226, L0902225, L0902617, L0903105, L0903142, L0903195,
L0904055, L0904070, L0904133, L0904149, L0904191, L0904224,
L0905030, L0905120, L1002270, L1003019, L1003256, L1004024,
L1 004056, L1004186, L1005083, L1005085, L1005200, L1005274,
L1103144, L1104011, L1104268, L1105121, L1203210, L1204008,
L1205168, L1205169, L204167 & LO604088;
c) Lot numbers: 13073872, 13078568, 13082798, 13084602, 13088356,
13096358, 40206984, 40604122, 40804442, 50205751, 50306355,
50403002, 50405034, 51104857, A0105904, A0106063, A0206419,
A1102924, X0105497, X0205439, X0305391, X0306127, X0306956,
X0405043, X0505118, X0704423, X0802743, X0805081 & X0905452;
d) Lot numbers: L0103107, L0103244, L0206088, L0306027, L0306082,
L0405345, L0704269, L0804090, L0902372, L1002091 & L1004055;
e) Lot numbers: 13073871, 13085576, L0103109, L0203006, L0206046,
L0206153, L0306085, L0504274, L0604126, L0702465, L0704300,
L0802224, L0802580, L0804091 & L0902619
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biosense Webster, Inc., Irwindale, CA, by letters on November 20, 2006 and December 9, 2006.
Manufacturer: Cordis de Mexico, S.A. de C.V., Cd. Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium.
VOLUME OF PRODUCT IN COMMERCE
32,317
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System, Recall # Z-0542-2007
CODE
List 12163-01, lot 39-126-5H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters dated December 20, 2006.
Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
The tubing can separate from the set at the filter inlet post.
VOLUME OF PRODUCT IN COMMERCE
7,656 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
LifeSync ECG System – Disposable leadwear, Ls-222, Ls-223, Recall # Z-0546-2007
CODE
C6310, C6324 and C6297
RECALLING FIRM/MANUFACTURER
Recalling Firm: GMP Companies/Lifesync Corp., Ft. Lauderdale, FL, by letter on January 15, 2007.
Manufacturer: Printec H. T. Electronics Corp., Chung-Ho City, Taipei Hsien. Firm initiated recall is complete.
REASON
When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.
VOLUME OF PRODUCT IN COMMERCE
272 cases
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized
polymer over activated carbon, 50mL, Recall # Z-0550-2007;
b) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized
polymer over activated carbon, 100mL, Recall # Z-0551-2007;
c) Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized
polymer over activated carbon, 175 mL, Recall # Z-0552-2007;
d) Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized
polymer over activated carbon, 250mL, Recall # Z-0553-2007
CODE
Lot number 564 though 577
RECALLING FIRM/MANUFACTURER
Clark Research and Development, Inc., Folsom, LA, by letter dated January 19, 2007 and February 5, 2007. Firm initiated recall is ongoing.
REASON
Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
VOLUME OF PRODUCT IN COMMERCE
292 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin , Recall # Z-0582-2007
CODE
Lot # 6073436
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on January 27, 2007.
Manufacturer: BD Medical - Diabetes Care, Holdrege, NE. Firm initiated recall is ongoing.
REASON
The needle becomes detached from the hub/syringe
VOLUME OF PRODUCT IN COMMERCE
247,824 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
______________________________

PRODUCT
Microalbumin Multi-Calibrator Set, in vitro diagnostic. Catalog Number: SE-252, Recall # Z-0536-2007
CODE
Lot Number: 28423
RECALLING FIRM/MANUFACTURER
Diagnostic Chemicals, Ltd., Charlottetown, Prince Edward Island, Canada, by telephone and fax on September 6, 2006. Firm initiated recall is ongoing.
REASON
Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct
VOLUME OF PRODUCT IN COMMERCE
38 kits
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) Terumo L Series 1863 type arterial perfusion cannulae, straight open tip,
1/4" connector, arterial cannula, 10 FR, 17.5 cm (7") long; Catalog no. L7350,
Z-0543-2007;
b) Terumo L Series 1863 type arterial perfusion cannulae, straight open tip,
1/4" connector, arterial cannula, 12 FR, 17.5 cm (7") long; Catalog no. L7351,
Recall # Z-0544-2007
CODE
a) Lot 2119436, exp. October 2009;
b) Lot 2119905, exp. October 2009.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by telephone on December 7, 2006. Firm initiated recall is complete.
REASON
The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide

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PRODUCT
CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers, Recall Z-0565-2007
CODE
Lot Number 42063I2, List Number 01H73-01
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter on December 22, 2006. Firm initiated recall is ongoing.
REASON
Results for tests of RBC, MCV, RDW, MPV and PLT may be falsely elevated or falsely decreased when the Cell Dyn Diluent/Sheath reagent is used with Cell-Dyn 4000, Ruby and Sapphire systems.
VOLUME OF PRODUCT IN COMMERCE
652 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR MARCH 7, 2007

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