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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Fresh Frozen Plasma 003FG60847, 003GP87171, 003FH33376, 003FG60860, 003FJ02956, 003GM69303, 003GZ91915, 003GH67898, 003GL86619, 003FJ03157, 003GF34965, 003FJ03054, 003FG60841, 003FH33377, 003FJ03203, 003FJ04267, 003GT82615, 003GL85915, 003GM69313, 003GM69316, 003FJ02949, 003GZ91895, 003GZ91905, 003GM69301, 003FJ04131, 003KH33536, 003KH33541, 003FG60872, 003FG60854, 003FG60887, 003FG60894, 003FJ02492, 003FJ02957, 003FJ03059, 003GP87150, 003GP87157, 003GP87162, 003GP87163, 003GT82897, 003FG60862, 003FJ02505, 003FJ03053, 003FJ02495, 003GL85906 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 003GH67904, 003FJ04113, 003FJ04265, 003KH33397, 003FJ03235, 003FJ04085, 003KH33583, 003GL87000, 003GM69301, 003GV27962, 003FJ02957, 003FJ03129, 003FJ03157, 003FJ03199, 003FJ03222, 003FJ04097, 003GH68242, 003GN58036, 003GN58173, 003GN58175, 003GN58177, 003GP87157, 003GP87162, 003GP87175, 003GT82633, 003GV27605, 003GV27607, 003GZ91021, 003GZ91027, 003KH33583, 003FM30656, 003FQ65447, 003GS74148, 003GX38999, 003FF87253, 003FF87278, 003FG60887, 003FJ02692, 003FJ02741, 003FJ02952, 003FJ03993, 003FJ04275, 003FQ66396, 003FQ66471, 003GH68260, 003GN58032, 003GT82887, 003GV27964, 003KH33308, 003LH10839, 003LH11700, 003FH33389, 003GS74160, 003FQ66528, 003KH32903, 003FJ04092, 003FJ04152, 003LC36433, 003GL86607, 003GL86613, 003GV27590, 003GX39005, 003FJ03218, 003FJ03257, 003FF87265, 003FF87274, 993FF87276, 003FJ02591, 003FJ02671, 003FJ02884, 003FJ03777, 003GF35168, 003GF35562, 003GJ68257, 003GL85903, 003GL85903, 003GL85906, 003GL86619, 003GL87413, 003GM69306, 003GS73536, 003KH33520, 003LH10763, 003GJ82678, 003GJ82687, 003GL86735, 003GN58278, 003GT82615, 003GZ91895, 003KH33397, 003GN57898, 003GP86382, 003GP86503, 003GX38995, 003LH11683, 003FF87219, 003FJ02910, 003FQ65474, 003FQ65489, 003FQ65506, 003FQ66569, 003GL86938, 003GL87003, 003GL87012, 003GN57694, 003GN57920, 003GN58169, 003GP87418, 003GT82623, 003GT82625, 003GT83846, 003GX39004, 003GZ91887, 003KH32893, 003GH67896, 003GZ89222, 003FJ04449, 003GL85910, 003GL85913, 003FJ02627, 003FJ04279, 003FJ04294, 003FQ66636, 003GL86623, 003GN58034, 003GN58084, 003GT82882, 003GT82890, 003LC37086, 003FF87217, 003FM30663, 003GL85915, 003GL85919, 003GP86391, 003GT83759, 003GL87434, 003GF35563, 003GT83755, 003FF87258, 003FH33377, 003FJ02794, 003FJ03781, 003FQ65453, 003FQ65459, 003FQ65501, 003FQ65520, 003FQ65524, 003GF34927, 003GF34932, 003GJF34939, 003GF34965, 003GF35148, 003GF35163, 003GF35178, 003GF35433, 003GH67902, 003GJ68264, 003GJ82237, 003GJ82240, 003GL85932, 003GL86589, 003GL86597, 003GL86987, 003GL86991, 003GL87006, 003GN58526, 003GN58528, 003GP86489, 003GS73557, 003GS74001, 003GS74012, 003GS74149, 003GT83110, 003GV27931, 003GZ90480, 003GZ91030, 003GZ91903, 003GZ91910, 003KH33306, 003LC37073, 003LC37083, 003LH10740, 003LH10771, 003GN58042, 003GF35450, 003FJ02495, 003FJ02505, 003GH68245, 003LC37058, 003FJ02509, 003FJ03119, 003FQ66623, 003GN58039, 003GS73555, 003GS73996, 003GT82617, 003GV27544, 003GN58055, 003GF35545, 003GF35570, 003GF35572, 003GP86600, 00GF35550, 003FJ03999, 003FH33380, 003FJ02648, 003FJ03118, 003FJ03163, 003FJ03765, 003FJ03787, 003FJ03803, 003FJ03874, 003FJ04006, 003FJ04030, 00FFJ04246, 003FJ04457, 003FJ04781, 003FQ65514, 003GF34943, 003GL87419, 003GP86519, 003GP87171, 003GS73540, 003GT83114, 003GX39011, 003GX39014, 003GZ90458, 003GZ90478, 003KH33356, 003FJ03871, 004FJ03892, 003FJ04298, 003FJ04834, 003FQ66607, 003GF34933, 003GF35495, 003GH67898, 003GH67924, 003GN57934, 003GP88681, 003GT82625, 003GZ91905, 003FQ66428, 003FQ66432, 003GL87011, 003KH33536, 003FJ02726, 003FJ04460, 003FJ04761, 003FJ04798, 003FJ04827, 003FQ66640, 003GV27604, 003LC36429, 003LH10655, 003FJ04131, 003GF34412, 003GH68247, 003GH68262, 003GP86631, 003GZ89244, 003GP87168, 003GS73543, 003GT82902, 003GT83745, 003GZ90536, 003GP86522, 003GX39007, 003FJ02682, 003FJ02747, 003FJ02949, 003GL87428, 003FG60841, 003FG60860, 003FJ02526, 003FJ03774, 003FM30639, 003FM30647, 003FM30670, 003FQ66336, 003FQ66502, 003GN58155, 003GN57681, 003GN57687, 003GN58167, 003GN58171, 003GN58273, 003GP86376, 003GR83850, 003GS74177, 003GZ91915, 003KH33562, 003LC36139, 003LC37064, 003FQ66520, 003GH67905, 003GP87168, 003GR83849, 003GS73991, 003GH67909, 003GJ82690, 003GL86995, 003GN57692, 003GP87168, 003GT82634, 003GV27921, 003GV27936, 003KH33292, 003KH33297, 003LC37085, 003GN57915, 003FJ04267, 003LC36197, 003LC37078, 003FJ02730, 003FJ02906, 003GL86600, 003FQ65528, 003FH33383, 003FQ66515, 003GF35158, 003GF35174, 003GL85924, 003GL86740, 003GN57758, 003GN58057, 003GS73997, 003GZ90992, 003GZ91910, 003GF35457, 003GP86509, 003FJ04100, 003FQ66523, 003GL86994, 003GS74158, 003FJ03997, 003GS74178, 003GZ90497, 003FJ04252, 003GF34954, 003GJ82676, 003GL86599, 003KH33541, 003FF87271, 003FH33380, 003FJ02602, 003GF35555, 003GL85921, 003GN58267, 003KH32903, 003KH34360, 003FG60862, 003FJ02488, 003GH68251, 003GL86595, 003GP87175, 003LC36187, 003FJ04789, 003GH67914, 003FJ04107, 003FJ04276, 003FJ04285, 003GM69303, 003GM69311, 003GN57900, 003GN57927, 003GN57930, 003GN58525, 003GT83759, 003GZ89224, 003GZ90468, 003GZ90998, 003GZ91043, 003KH33410, 003LC36142, 003LH10821, 003LH10825, 003FJ03054, 003FJ03059, 003FJ04147, 003GL86620, 003GL86737, 003GL86738, 003GX39008, 003GS74144, 003GT82610, 003GN58178, 003FG60847, 003FG60872, 003FG60894, 003FJ02492, 003FJ02511, 003FJ02705, 003FJ02705, 003FJ02773, 003FJ02853, 003FJ03053, 003GL82688, 003GL87432, 003GN57766, , 003GN57902, 003GN57918, 003GN58065, 003GN58258, 003GP86481, 003GS74163, 003GV27945, 003GV27949, 003GX38997, 003GZ89249, 003GZ89257, 003KH34310, 003LC36212, 003LC36213, 003GN58268, 003FJ04455, 003FQ65465, 003FQ65487, 003GF34966, 003GH67914, 993GJ82691, 003GL85926, 003GM69313, 003GM69316, 003GN57928, 003GP87150, 003GP87413, 003GP88674, 003GT82612, 003GT82895, 003GZ91887, 003GZ91919, 003KH33411, 003LH10838, 003KH33306, 003GN58263, 003GP86501, 003GP86612, 003GL86988, 003GM69307, 003GN58044, 003GN58070, 003GZ91885, 003GZ91898, 003FF87260, 003FJ02956, 003GN58514, 003FJ04271, 003GT82604, 003KH32898, 003GN58516, 003GT83760, 003FJ04249, 003KH33325, 003LH11719, 003FJ03112, 003FJ04116, 003FQ66487, 003GF35156, 003GN57685, 003GN58512, 003GT83759, 003GT83848, 003GX39009, 003FJ02589, 003GJ68262, 003GL87426, 003GP87421, 003GF35487, 003GF35512, 003GP86544, 003GR83852, 003GS74006, 003LC36432, 003GL86591, 003KH33352, 003FJ02518, 003FJ02596, 003FJ03203, 003FJ04291, 003FJ04462, 003FJ02671, 003FJ02691, 003FJ03879, 003GL86612, 003GN58032, 003GN58164, 003GS74154, 003GS74156, 003FJ02672, 003FJ04107, 003FJ04291, 003FQ66489, 003FQ66509, 003GF35524, 003GP86388, 003GS74165, 003GV27943, 003GZ89268, 003GZ90561, 003GZ91017, 003KH33390, 003KH33405, 003KH33522, 003LC36206, 003LH11668, 003FH33378, 003KH33401, 003KH33412, 003FH33376, 003GF35574, 003GJ82655, 003GL86620, 003GL86738, 003GL86987, 003GN58049, 003GN58058, 003GT82891, 003FJ02488, 003GN58069, 003KH33522, 003FJ02806, 003GL87416, 003GN57689, 003FJ04156, 003FQ66532, 003GF34962, 003GV27638, 003GL86624, 003GL86626, 003GT82886, 003GT83752, 003GP86569, 003GT83747, 003GT83852, 003GZ91882, 003GZ91916, 003KH33301, 003GP86387, 003FJ04849, 003GN57909, 003FQ65496, 003GF34847, 003FJ02823, 003FJ02882, 003GN58039, 003GN58048, 003GP88680, 003LC36190, 003FF87273, 003FM30638, 003FM30645, 003FM30651, 003GN58080, 003GN58081, 003KH33571, 003LH10748, 003FQ66367, 003GN58275, 003GS74169, 003GV27591, 003GZ91907, 003KH34260, 003GF35765, 003FG60854, 003GZ89241, 003GL87425, 003GN57762, 003GN57896, 003GN57904, 003KH33392, 003FJ03251, 003GH67893, 003GP86548, 003LH11733, 003FQ66352, 003GF34423, 003GF34429, 003GL87421, 003GS73537, 003GS73549, 003GZ90517, 003FH33395, 003GL86602, 003GM69331, 003GM69333, 003GN58156, 003GP86624, 003FJ03784, 003GZ90585, 003FJ04248, 003FJ04255, 003GF34957, 003FJ03889, 003KH33407, 003FQ66575, 003GF35560, 003GF35581, 003GT82629, 003GZ91021, 003GZ91027, 003FH33397, 003FM30630, 003FJ03150, 003GN58083, 003FJ03232, 003GM69334, 003GM69336, 003GT82606, 003GF35170, 003GN58062, 003LC36202, 003FM30619, 003FQ66462, 003GL86742, 003GP86562, 003GN58274, 003GV27635, 003GV27933, 003KH33551, 003LC36145, 003LC37087, 003GN58519, 003GF35151, 003GH68266, 003GN57767, 003FJ02838, 003FJ04741, 003FJ04812, 003GN57768, 003GP86591, 003GV27929, 003GZ89265, 003GS74175, 003GZ89265, 003GT82903, 003FG60906, 003FJ04747, 003GX39003, 003FF87272, 003FJ02521, 003GP87163, 003GN57908, 003GN57912, 003GN57916, 003GP86501, 003GP86506, 003GP86612, 003GZ90517 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Cryoprecipitated AHF 003GV27949, 003FJ02884, 003GV27964, 003KH33344, 003LH10821, 003FJ04781, 003FJ04798, 003GF35795, 003GP86523, 003GP86605, 003GV27591, 003GZ89224, 003GJ82676, 003GP86481, 003GP86544, 003GZ89244, 003FJ02602, 003FJ02648, 003FJ02794, 003GP86489, 003GP86509, 003GP86631, 003GP87413, 003KH32893, 003KH33308, 003LH10825, 003FJ02773, 003FJ02906, 003LC37060, 003FJ02627, 003FJ02726, 003FJ04455, 003FJ04460, 003FJ04761, 003GF35765, 003GH68251, 003GH68254, 003GH68255, 003GH68239, 003GH68260, 003GH68266, 003GL86597, 003GV27927, 003LC36145, 003GJ82687, 003FJ04030, 003GP86612, 003GP86624, 003GT83747, 003LH10652, 003FQ66352, 003FJ04747, 003GP86569, 003GV27537, 003GV27590, 003LH10740, 003GZ89268, 003KH33301, 003GP86519, 003GV27929, 003FJ04834, 003GZ89241, 003GV27537, 003GV27581, 003GV27635, 003GZ89257, 003LH10838 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Plasma Frozen 003FJ03218, 003FJ03251, 003FJ03257, 003GF34429, 003GZ90458, 003FJ04116, 003FJ04156, 003FJ04248, 003FM30670, 003FJ04279, 003LH10832, 003FJ03199, 003FJ03129, 003GF34423, 003GL85921, 003FJ03118, 003GM69311, 003GN57933, 003GN58514, 003FJ04265, 003FJ04285, 003GP86536, 003GP86562, 003GN57918, 003GN58058, 003GT82633, 003LC36213, 003GS73555, 003LC36202, 003FJ03163, 003GL85913, 003GL85919, 003FJ04100, 003GL86612, 003GL86735, 003GL86740, 003GN57765, 003GN58055, 003GN58278, 003GN58512, 003GN58525, 003GS73540, 003GT82617, 003GT82629, 003GT82882, 003GT82895, 003KH33294, 003FH33395, 003FJ04092, 003FJ04113, 003GF35545, 003GH67896, 003GH67909, 003GL86607, 003GL86742, 003GL87012, 003GL87420, 003GM69331, 003GM69333, 003GT82886, 003GV27943, 003GZ91002, 003GZ91903, 003KH33390, 003KH33397, 003FM30663, 003GN57920, 003GN57928, 003KH33405, 003LC36190, 003FH33389, 003FJ03235, 003FQ65520, 003FQ65501, 003GL87000, 003GZ91898, 003GZ91916, 003GZ91919, 003FJ04298, 003GN58044, 003GN58519, 003GT82612, 003KK33404, 003GL86985, 003GN57896, 003GN57902, 003GN58526, 003KH33407, 003GN58516, 003FJ04249, 003FJ04252, 003FJ04255, 003GF35560, 003GL86938, 003GL86943, 003GN57681, 003GN57933, 003GN58048, 003GT82606, 003GZ90478, 003KH33401, 003KH33411, 003KH33412, 003LC36206, 003LC36212, 003FF87219, 003FJ03112, 003FJ03119, 003GL86624, 003GL86626, 003GM69314, 003FQ66623, 003FJ04294, 003FQ66515, 003GF35572, 003GF35581, 003GN57930, 003GN57934, 003GN58052, 003KH33392, 003GF34954, 003GL86994, 003GN57912, 003GN57915, 003GN58263, 003GN57904, 003GN57916, 003GN57927, 003FJ03222, 003FJ04246, 003FM30619, 003FJ03892, 003GF35170, 003GF35562, 003GF35563, 003GL85926, 003GL85932, 003GN57909, 003GN58042, 003GS73536, 003GS73557, 003FQ66495, 003GF34957, 003GL86995, 003GT82902, 003GH67924, 003GS73537, 003GS73549, 003GS73543 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 003FJ04272, 003LH11439, 003FJ04289, 003FJ03788, 003FJ03788, 003FJ03883, 003FJ04272, 003FQ66502, 003LH11439, 003FJ04289, 003GZ90988, 003GL86991, 003LH11668 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Blood Products - Other 003GP87443, 003LC36193, 003FG60886, 003FJ02526, 003FJ02707, 003FJ02954, 003GP87415, 003GP87425, 003GP87438 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Plasma Cryoprecipitate Reduced 003GJ2687, 003GJ82691, 003GP86605, 003FJ02589, 003GP86506, 003GV27931, 003GV27964, 003GV27604, 003GV27638, 003FJ04006, 003FJ04030, 003FJ04460, 003FJ04006, 003FJ04030, 003FJ04460, 003GF35512, 003GF35524, 003GF35528, 003GF35550, 003GJ82691, 003GL87011, 003GZ89213, 003GP86509. 003GP86548, 003GP86501, 003GJ82688, 003GV27921, 003GV27635, 003GZ89222, 003GT83745, 003KH33562, 003GJ82676, 003GF35487, 003GP86503 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Blood and Blood Products for Reprocessing 003KH32893, 003KH32898, 003KH32903, 003FF87265, 003FF87271, 003FF87272, 003FF87273, 003FF87274, 003FF87276, 003FF87278, 003FG60886, 003FH33378, 003FH33383, 003FH33387, 003FH33397, 003FJ02509, 003FJ02511, 003FJ02518, 003FJ02596, 003FJ02602, 003FJ02627, 003FJ02634, 003FJ02671, 003FJ02672, 003FJ02682, 003FJ02691, 003FJ02692, 003FJ02705, 003FJ02707, 003FJ02726, 003FJ02730, 003FJ02741, 003FJ02747, 003FJ02526, 003FJ02773, 003FJ02794, 003FJ02833, 003FJ02838, 003FJ02869, 003FJ02882, 003FJ028884, 003FJ02906, 003FJ03150, 003FJ03765, 003FJ03774, 003FJ03777, 003FJ03787, 003FJ03803, 003FJ03871, 003FJ02530, 003FJ03781, 003FJ03784, 003FJ03874, 003FJ03889, 003FJ03993, 003FJ03997, 003FJ03999, 003FJ04003, 003FJ04085, 003FJ04147, 003FJ04152, 003FJ04271, 003FJ04275, 003FJ04276, 003FJ04457, 003FJ04462, 003FJ04761, 003FJ04781, 003FJ02591, 003FJ03879, 003FJ04789, 003FJ04798, 003FJ04812, 003FJ04827, 003FJ04834, 003FJ04849, 003FJ04857, 003FM30630, 003FM30639, 003FM30647, 003FM30651, 003FM30659, 003FQ65447, 003FQ65459, 003FQ65465, 003FQ65487, 003FQ65489, 003FQ65496, 003FQ65506, 003FQ65514, 003FQ65524, 003FQ66336, 003FQ66352, 003FQ66367, 003FQ66380, 003FQ66396, 003FQ66428, 003FQ66447, 003FQ66462, 003FQ66487, 003FQ66489, 003FQ66508, 003FQ66509, 003FQ66523, 003FQ66528, 003FQ66532, 003FQ66569, 003FQ66575, 003FQ66600, 003FQ66607, 003FQ66617, 003FQ66636, 003FQ66640, 003GF34412, 003GF34927, 003GF34932, 003GF34939, 003GF34943, 003GF34962, 003GF34966, 003GF35148, 003GF35151, 003GF35156, 003GF35158, 003GF35163, 003GF35168, 003GF35174, 003GF35178, 003GF35450, 003GF35457, 003GF35510, 003GF35555, 003GF35570, 003GF35756, 003GF35770, 003GF35795, 003GH67904, 003GH67905, 003GJ82237, 003GJ82240, 003GJ82690, 003GL85910, 003GL86589, 003GL86591, 003GL86610, 003GL87003, 003GL87006, 003GL87419, 003GM69306, 003GM69307, 003GM69334, 003GM69336, 003GN57685, 003GN57687, 003GN57689, 003GN57692, 003GN57758, 003GN57762, 003GN57764, 003GN57766, 003GN57767, 003GN57898, 003GN57900, 003GN58036, 003GN58049, 003GN58059, 003GN58062, 003GN58065, 003GN58069, 003GN58070, 003GN58080, 003GN58081, 003GN58083, 003GN58084, 003GN58155, 003GN58156, 003GN58164, 003GN58167, 003GN58169, 003GN58171, 003GN58173, 003GN58175, 003GN58177, 003GN58178, 003GN58273, 003GN58528, 003GP86376, 003GP86382, 003GP86387, 003GP86388, 003GP86391, 003GP86395, 003GP86481, 003GP86519, 003GP86522, 003GP86523, 003GP86536, 003GP86544, 003GP86591, 003GP86600, 003GP86612, 003GP86624, 003GP87413, 003GP87415, 003GP87418, 003GP87421, 003GP87425, 003GP87438, 003GP87443, 003GP88674, 003GP88680, 003GP88681, 003GR83849, 003GR83850, 003GS73991, 003GS73997, 003GS74001, 003GS74006, 003GS74012, 003GS74014, 003GS74016, 003GS74144, 003GS74149, 003GS74154, 003GS74156, 003GS74158, 003GS74160, 003GS74163, 003GS74165, 003GS74169, 003GS74175, 003GS73996, 003GS74177, 003GS74178, 003GT82604, 003GT82623, 003GT82634, 003GT82890, 003GT82891, 003GT82897, 003GT83110, 003GT83846, 003GT83848, 003GV27605, 003GV27607, 003GV27933, 003GV27936, 003GX38995, 003GX38997, 003GX38999, 003GX39003, 003GX39005, 003GX39007, 003GX39008, 003GX39009, 003GX39011, 003GX39014, 003GZ89224, 003GZ89241, 003GZ89244, 003GZ89257, 003GZ89268, 003GZ90468, 003GZ90469, 003GZ90536, 003GZ90561, 003GX39004, 003GZ90585, 003GZ90992, 003GZ90998, 003GZ91017, 003GZ91030, 003GZ91037, 003GZ91043, 003GZ91882, 003GZ91885, 003KH33292, 003KH33294, 003KH33297, 003KH33301, 003KH33306, 003KH33308, 003KH33325, 003KH33344, 003KH33352, 003KH33356, 003KH33410, 003LC36145, 003LC36187, 003LC36193, 003LC36197, 003LC36429, 003LC36432, 003LC36433, 003LC37060, 003LC37064, 003LC37068, 003LC37073, 003LC37074, 003LC37083, 003LC37086, 003LC37087, 003LC37091, 003LH10652, 003LH10655, 003LH10740, 003LH10748, 003LH10771, 003LH10821, 003LH10832, 003LH10838, 003LH10839, 003LH11670, 003LH11677, 003LH11683, 003LH11700, 003LH11717, 003LH11719, 003LH11733, 003FQ65474, 003FF87217, 003FF87253, 003FF87258, 003FF87260, 003FF87264, 003GL86595, 003GL86600, 003GL86602, 003GF35441 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 003GV27581, 003FJ02530, 003FJ04857, 003GV27927, 003KH33533, 003FJ02634, 003GF35510 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced Washed 003KK33404, 003KK33404 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 42FP21738 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 42FP21738 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 42FH43871A ; 42FH43871B Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 042KW33803 Part 1; 042KW33803 Part 2 Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 42W48250 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 42W48250 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pooled Leukocytes Reduced 42W48250 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 42KW34507 Part 1 ;42KW34507 Part2 ; 42KW34507 Part 3; 42KW34509 Part 1; 42KW34509 Part2 ;42KW34509 Part 3; Class II Blood products, which did not meet the acceptable product specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 42FW32111 Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 42FW32111 Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06LT49908 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 06LT49908 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced Irradiated 06KG46732; 06KL46469 Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 03GF09638, 03KY26020, 03GR75452, 03LR78190, 03GX32055, 03GE05381, 03GQ87695, 03GC18947, 03GF12818, 03LL25898, 03GL62942, 03FL91574, 03KM30429, 03KY25409, 03GH64329, 03GL73320, 03FG31338, 03FJ70500, 03LJ23148, 03LJ23217, 03GT66134, 03FY06824, 03GH64892, 03FY06823, 03GR72270, 03E43717, 03LE16311, 03KM28453, 03FQ27072, 03FJ11128, 03KP28513, 03V32203, 03GJ79944, 03GF01631, 03FH23337, 03L54792, 03S25584, 03K27768, 03GG04059, 03FH24839, 03GT70020, 03KM30430, 03GT70025, 03LM16445, 03KJ11370, 03KM30456, 03FQ35775, 03FG39429, 03LE20853, 03GH64075, 03FF76439, 03FJ76769, 03FQ35518, 03GT69736, 03KM30380, 03FQ35606, 03E47636, 03E48286, 03GG09770, 03GQ82682, 03GZ58315, 03KY25342, 03GG09868, 03GZ58590, 03FQ36089, 03GN48838, 03GZ58659, 03E48676, 03GX30829, 03S28920, 03GG10241, 03FX40681, 03LJ29658, 03FL00183, 03LE20834, 03FJ76729, 03FJ76966, 03LX28894, 03GZ58097, 03H31070, 03KQ31017, 03L64496, 03V34751, 03GP10755, 03GF86033, 03LH08302, 03KM24130, 03GF85987, 16LR54121, 03GP44080, 03GP43221, 03LX21097, 03GS57193, 03GC08585, 03LG19142, 03FG24447, 03GQ64568, 16KC22130, 03KK27110, 03KP21685, 03GQ82836, 03GX30664, 03FX40959, 03GX30635, 03FX40949, 03GY35781, 03GX30641, 03LX28947, 03FJ77403, 03LE21738, 03GS63661, 03FY06515, 03GS63645, 03FG40360, 03KY25536, 03GK80882, 03LL41732, 03LL41742, 03GG09872, 03GR74740, 03G27884, 03GX30649, 03R32421, 03GH64355, 03FQ37915, 03KY26275, 03GQ85184, 03FQ37868, 03L65670. 03GM62217, 03LE23629, 03GJ81154, 03H32097, 03GM62225, 03LR76749, 03FM18376, 03KK37727, 03LG26828, 03GM62110, 03LG26770, 03LG26771, 03K31294, 03FY06702, 03GT70664, 03GZ60449, 03LW36501, 03KC26909, 03L65662, 03FQ38057, 03GW36446, 03FJ78266, 03S29481, 03FQ40965, 03GT55262, 03FQ37945, 03FF77607, 03FQ37550, 03LR76321, 03GK81899, 03GG11566, 03GC18474, 03KF17165, 03GK82108, 03GH64930, 03LC27010, 03FG42470, 03FQ37834, 03K31869, 03FV90732, 03GZ60451, 03GZ60471, 03GR75363, 03LC26975, 03L65036, 03FF77822, 03FJ78284, 03GH65022, 03FJ78306, 03FJ78301, 03FJ78296, 03G28488, 03FQ38140, 03KJ11976, 03GT71136, 03GJ81164, 03GG11805, 03GT71155, 03GT71133, 03LE24038, 03E50104, 03GZ60535, 03LE24167, 03FL01091, 03LE24102, 03GR75335, 03L65284, 03KY26265, 03GG11423, 03H32028, 03GG11634, 03FQ37689, 03K31367, 03GZ60117, 03LS27451, 03LX30283, 03LN36427, 03LG27001, 03GG12120, 03GT71135, 03LJ31019, 03LX29872, 03FV90751, 03FJ78292, 03FJ78318, 03KP31537, 03L65048, 03GG11411, 03LE24147, 03GW36944, 03LN36609, 03LE25326, 03GS64937, 03GS64848, 03FJ79138, 03GK82919, 03K32256, 03GK82898, 03V35055, 03GT71472, 03FJ78583, 03GN49751, 03LX30248, 03L66221, 03LW36773, 03FQ38723, 03GG12405, 03GQ86198, 03LJ31502, 03FJ79033, 03LC27227, 03FQ38660, 03LE24871, 03GG12240, 03GP61707, 03LS27864, 03GW36741, 03LR77362, 03R33804, 03FJ78964, 03FQ38282, 03FJ78570, 03FJ78492, 03KH30488, 03LX30098, 03GS64802, 03KC27137, 03LM17067, 03GC18717, 03FJ79053, 03LR77369, 03GS64815, 03E50794, 03LG27326, 03LE24855, 03GK82612, 03GR75593, 03GZ61291, 03GN49761, 03S29907, 03GT71121, 03K31892, 03GK82209, 03LS27911, 03GT71590, 03LX30226, 03FL01253, 03GQ86249, 03GF11546, 03GK82124, 03FX41054, 03LN36515, 03LX30279, 03KK38553, 03FQ38706, 03R33772, 03FJ78996, 03GF1142, 03LR77368, 03GS64742, 03KP32068, 03LJ31305, 03GT71446, 03FX41162, 03E50663, 03GR75673, 03GG12433, 03GQ85906, 03GF10909, 03FG42823, 03GP61447, 03LX30115, 03GZ61280, 03LE24619, 03FJ78866, 03GF11088, 03G28740, 03FJ78771, 03FY06917, 93LG27120, 03H32207, 03GM62275, 03LE24142, 03L65849, 03GF09720, 03LR76395, 03L65847, 03GP61108, 03GH65005, 03FY06875, 03FJ78454, 03LF31041, 03GR75415, 03FG42484, 03GF10166, 03GZ60608, 03LM16943, 03KY26290, 03GN49709, 03LR77036, 03FG42629, 03FM18672, 03GZ61479, 03FJ78970, 03FV90841, 03GG12280, 03LJ31422, 03LX29841, 03GF11145, 03GT71381, 03GF11170, 03GT71141, 03R33679, 03GC18665, 03FQ38595, 03FQ38593, 03LE24857, 03GF11305, 03LE24856, 03FQ38610, 03GK82559, 03GP61457, 03GL75763, 03FJ78689, 03FG42686, 03GS64675, 03GG11935, 03V35015, 03L66209, 03KY26352, 03GF11074, 03LW36648, 03GF10302, 03GG12219, 03FQ37842, 03LE24483, 03FY06897, 03LF30999, 03LE24864, 03FX41043, 03GF11301, 03GT71497, 03LN36431, 03GK82883, 03FJ79351, 03LW36893, 03LR77491, 03GR75689, 03GH65165, 03FG42640, 03FQ25835, 03GJ79656, 03KC25279, 03GR72240, 03KP28567, 03LJ25406, 03FX39539, 03LJ25500, 03GW32710, 03FQ27985, 03LX26658, 03K28271, 03FJ72650, 03LW33873, 03E43652, 03L55979, 03LC24484, 03FQ28136, 03K27919, 03L54234, 03LG23790, 03GF00619, 03LE21554, 03L63594, 03GF08278, 03H31293, 03GF08262, 03GF08558, 03LG26301, 03GF08605, 03LM16520, 03GW35565, 03FV89908, 03FF76717, 03LJ29756, 03FG40544, 03GP60246, 03GP60245, 03LF25792, 03LL46667, 03GN43306, 03GQ67729, 03GN43300, 03GQ67760, 03LC21525, 03LH09256, 03GG95828, 03GN43916, 03GN43914, 03GN43786, 03GG97474, 03LX23665, 03FR54719, 03GW29555, 03LL47423, 03L47609, 03FL97988, 03GN43846, 03FJ76761, 03LW35575, 03LR75959, 03GP60262, 03GP60274, 03GQ82785, 03GF08030, 03GK81033, 03KP31286, 03FW84868, 03LL48236, 03LS20426, 03FL97435, 03GW29387, 03GW29384, 03FV83275, 03FG27833, 03LM12005, 03LN28823, 03KP26876, 03GF92936, 03FV83041, 03FV83075, 03GZ44162, 03FG27733, 03GQ69794, 03K23760, 03FG27732, 03GF93167, 03GC11957, 03GC12401, 03FF72387, 03LL49996, 03GS60240, 03GY32372, 03FG28019, 03GW29767, 03FQ23681, 03LE11227, 03GF93696, 03LL49800, 03GZ46003, 03LL50267, 03LR73350, 03FM14244, 03GS61211, 03GC13675, 03LS22133, 03KE23441, 03GN45366, 03GC13674, 03KF15948, 03LG22392, 03K25928, 03KK31571, 03FV84703, 03KT11759, 12GS57098, 03GF96650, 03LS21747, 03FH21935, 19FZ12596, 19GF63002, 03LG23204, 03LF28471, 03GF97887, 03KT12164, 03LC23228, 03GQ83036, 03GT69962, 03FW88976, 03GG02808, 03FJ69417, 03LN31072, 03LX25654, 03KK32411, 03GT64838, 03R28166, 03GZ47626, 03GZ47473, 03V30869, 03LM14266, 03KP27774, 03LX24208, 03LW31855, 03GC13112, 03G23077, 03L49862, 03LL52445, 03GH61052, 03LC22483, 03LM13686, 03GG99108, 03GW30094, 03GJ78588, 03LN29523, 03GC14160, 03GG02036, 03GL73196, 03GZ48677, 03LM14753, 03GT65778, 03GH61733, 03FV85907, 03GC14263, 03V31539, 03GH61801, 03FX38138, 03FG30931, 03GK76061, 03LW32784, 03FQ25722, 03GW31814, 03LC26621, 03GZ58607, 03GM61694, 03FM17827, 03LX29144, 03FQ35993, 03FF77496, 03GM61976, 03GC18365, 03FH25022, 03GS56764, 03FV79480, 03LC19889, 03GS56769, 03GN41368, 03FF70314, 03FR51905, 03GS56600, 03KJ08534, 03LL39797, 03GP42505, 03FV79324, 03FH18922, 03KF16875, 03R32027, 03LS26182, 03LE20713, 03E47921, 03LE20713, 03E47901, 03LE20652, 03LE20692, 03LE20711, 03LE20707, 03GQ82162, 03R31849, 03S28366, 03LG25799, 03FJ76736, 03KP31132, 03FQ35538, 0FFJ76737, 03FW88982, 03FW88980, 03FJ76764, 03GX30383, 03GC17822, 03LC26373, 03GZ57658, 03GN48763, 03L63171, 03R32149, 03FG39321, 03LE20952, 03H30982, 03FX40639, 03GW35016, 03GK80057, 03LC26087, 03GS63707, 03GG09565, 03GR74584, 03LE20936, 03GQ82436, 03LM16334, 03FF76442, 03GR74538, 03FX40900, 03LE20884, 03GQ82345, 03GP59995, 03FG39420, 03LX28802, 03GX30381, 03GC17767, 03GG09749, 03KY25205, 03LG26147, 03GT69905, 03S28648, 03L63403, 03S28680, 03LC26179, 03KE26102, 03R32121, 03LN34753, 03LM16303, 03GS63722, 03FQ35383, 03GP59517, 03GX30463, 03KJ10947, 03FX40618, 03GG08952, 03LC25896, 03FG37934, 03V34209, 03LE19772, 03GG08665, 03FQ35030, 03GF06558, 03GW35184, 03FQ34430, 03GF07166, 03FL00094, 03FG38970, 03FJ76445, 03LG25927, 03LX28664, 03FX40840, 03GK80102, 03FG38809, 93GF06841, 03LG25841, 03LC26103, 03KK36666, 03LN34553, 03FR57825, 03LC26152, 03LC26153, 03FQ35138, 03FY06438, 03FJ76187, 03GT69479, 03FL00181, 03FY06442, 03GF06978, 03L60244, 03LE19047, 03GG08571, 03GW36391, 03GW36391, 03GL75540, 03V34194, 03FL99738, 03FX40484, 93LE19264, 03GF05621, 03GF05706, 03H30021, 03GH62800, 19GH61146, 03FV88718, 03GZ55697, 03FG37310, 03GF04940, 03LW35013, 03GF05389, 03GF02099, 03FM16447, 03H29692, 03FW87476, 03FQ29501, 03GQ76888, 03LC24500, 03KT13685, 03LJ26271, 03LX27079, 03L56881, 03GQ77774, 03LJ26345, 03KE24695, 03GR72956, 03FG35337, 03GF02302, 03LW34397, 03K29010, 19V08963, 03GF02303, 03KP31307, 03FR58037, 03H31174, 03GC18109, 03LC26714, 03GN49068, 03FV90004, 03LM16481, 03FR58345, 03GR74898, 03LN35181, 03LC26556, 03FV90043, 03LS26781, 03GF08658, 03FJ77755, 03GQ83726, 03LS26812, 03FQ36226, 03GG10401, 03FM17967, 03S28976, 03GK81347, 03GK81388, 03FR58341, 03V34759, 03FQ36499, 03V34772, 03LE22222, 03FQ36485, 03FQ36482, 03H31218, 03GZ58495, 03GS64043, 03FQ37102, 03FQ37103, 03GZ59545, 03KQ31257, 03L64908, 03LE23045, 03GZ59479, 03FQ36881, 03LJ30357, 03L43345, 03GE04095, 03LL46731, 03V28691, 03R25552, 03GF89790, 03GG94049, 03FL96663, 03KT10631, 03E33604, 03G20140, 03LJ16493, 03GN43012, 03LJ17429, 03FH20565, 03KM25519, 03GG93110, 03KM24523, 03KQ26603, 03L42934, 03LL44293, 03L43260, 16GQ08292, 16LX53857, 03GC08806, 03GF86918, 03FG24700, 03FG24671, 03GF86242, 03GC08806, 03GF86918, 03LR71005, 03LE09356, 03KC23111, 03GQ67596, 03GS59013, 03L44970, 03GZ41761, 03GT62035, 03GT62028, 03KM25949, 03LR71869, 03KP24164, 03KP24161, 03KP24153, 03KM25945, 03KP24163, 03KE22261, 03FL90976, 03E23146, 03GR60367, 03LG14756, 03GS51057, 03K16617, 03LM94716, 03LC14566, 03LR64587, 03LF16335, 03GT53953, 03V23648, 03GT53716, 03GH52790, 03LC15285, 03GG79211, 03GP41221, 03GT54266, 03GT54243, 03LF16945, 03LC15556, 03V23878, 03FH13548, 03GK63322, 03KY11261, 03GL62287, 03LM95612, 03L27544, 03L27563, 03GC02163, 03L27524, 03LL25659, 03GH53218, 03GF73560, 03KP14497, 03H17127, 03KF13012, 03KY11650, 03GH53825, 03GX22323, 03LC15920, 03GH54077, 03GR61698, 03GN38663, 03GJ74383, 03GT55262, 03KP15048, 03L28890, 03LM96947, 03LL28625, 03LM97400, 03LL28580, 03GR61849, 03FL92010, 03KJ05705, 03FV72537, 03LL27275, 03KF13373, 03LF18554, 03GJ74803, 03GZ29270, 03GF75449, 03GJ74765, 03KQ19240, 03LG15392, 03KJ06355, 03KJ06354, 03LM97374, 03FX30548, 03FH14968, 03LC16881, 03S15570, 03LH05947, 03LC17024, 03LM97992, 03GL64895, 03FX30862, 03FX31009, 03FX31680, 03FX31662, 03GZ29671, 03LM97989, 012L64628, 012FV09758, 012FJ17822, 03LR66426, 03GZ31612, 03R21577, 03GQ56952, 03LG16557, 03GL66343, 03GL66369, 03GZ32140, 03LH06768, 03GF78787, 03LL32868, 03G14543, 03LL34056, 03GT57518, 03FL93377, 03GT57549, 03LR68149, 03GT57588, 03GR63765, 03GR63777, 03LL34944, 03LL34989, 03GF80490, 03KP18620, 03LR68218, 03LC17958, 03GT57385, 03GF79325, 03LX18899, 03KP18224, 03GG86458, 03FV77588, 03FH17794, 03LC18903, 03GG88680, 03V26406, 03H20883, 03K20038, 03G16920, 03S20020, 03FH18937, 03GT59767, 03GT59761, 03GZ37501, 03KP20678, 03FW83455, 03L39099, 03L39123, 03E30177, 03LG18250, 03GG89607, 03GG89630, 03GT59579, 03KY14753, 03LL40117, 03FR52101, 03GG10310, 03FQ36194, 03GT70373, 03FJ77832, 03GM61801, 03GF08592, 03FM17977, 03LE22097, 03G27903, 03GM61692, 03GP60473, 03GS64055, 12FX84927, 03GK81175, 03GH64510, 03GT70374, 03GH64513, 03GW35675, 03FJ77693, 03FQ36320, 93FJ77767, 03KK37038, 03FQ36418, 03FG40781, 03FJ77856, 03FQ36166, 03GR75039, 03LG26476, 03GF08665, 03GZ58718, 03KK36920, 03LN35387, 03FJ77970, 03KJ11644, 03FQ36389, 03KY25746, 03FY06615, 03H31439, 03LE22162, 03LM16656, 03GQ84130, 12K01955, 03LE22454, 03LF30503, 03GQ84146, 03LG26618, 03FG40982, 03GF09113, 03LX29442, 03GG10669, 03S29117, 03LN35522, 03KK37175, 03S29157, 03GK81483, 03KQ31227, 03LE22736, 03GQ84252, 03GQ84226, 03E49369, 03K31249, 03GZ59287, 03FQ36479, 03FH25127, 03K31270, 03K31251, 03FH25004, 03FV90162, 03R32930, 03L64642, 03FV90188, 03KQ31157, 03FV90154, 03FQ36371, 03LW36041, 03KH30199, 03LE22543, 03FH25126, 03FQ36510, 03S29313, 03GF09369, 03S29395, 03FH25121, 03LG26638, 03KY25946, 03KJ11775, 03GF09346, 03GK81630, 03GZ59730, 03LE23284, 03GP60659, 03GS64279, 03GZ59747, 03KM30576, 03GK81138, 03E49586, 03LJ30050, 03LE23091, 03L64906, 03S29345, 03KH30262, 03GM61718, 03LS26784, 03GF08443, 03KY25666, 03GQ83464, 93FL00535, 03FQ36357, 03GF08943, 03L64410, 03GG10422, 03GH64513, 03LF30553, 03LE22219, 03LS26868, 03KH30159, 03GF08118, 03GF08846, 03FY06616, 03KJ11518, 03L64453, 03LJ30069, 03LN35370, 03E49124, 03GG10540, 03FQ36442, 03GN49263, 03GZ58837, 03LX29331, 03S29206, 03GK81387, 03LG26623, 03GT70573, 03GT70599, 03LJ30101, 03GH64592, 03GQ83707, 03H31388, 03KK37085, 03LE23389, 03GW36123, 03E49766, 03GX31472, 03GT69960, 03KK37551, 03FG41475, 03S29426, 03GZ59743, 03LF30520, 03FM18017, 03GF09076, 03FV90268, 03LE23396, 03GG11298, 03FF77780, 03GF10062, 03FJ77949, 03FF77415, 03S29323, 03GP60616, 03GR75108, 03KY25995, 03GZ59799, 03LX29618, 03KP31548, 03E49875, 03GH64795, 03V34844, 03GP60746, 03GZ59886, 03GZ59969, 03GM62053, 03LE23634, 03KM30854, 03FF77556, 03GP60906, 03KK37830, 03LN35719, 03GX31474, 03KY26140, 03FF77688, 03GQ84664, 03KY26147, 03K31666, 03GG11193, 03GK81747, 03LN35602, 03LX29665, 03KM30802, 03GE05186, 03GT70802, 03KY26019, 03FQ37222, 03FY06803, 03LC27080, 03H31804, 03GG11150, 03GH64873, 03LN35796, 03GW36070, 03L64740, 03LS27330, 03LW36380, 03GR75365, 03LX29593, 03FG41009, 03GL75519, 03LE26641, 03GR76663, 03LG27924, 03FJ78947, 03GZ62024, 03LE26395, 03E51626, 03KE26963, 03GZ62923, 03KC27423, 03GG12846, 03FQ40429, 03GC19255, 03GC19129, 03FX41322, 03KY26799, 03FF78162, 03FQ41114, 03R34754, 03LJ32535, 03GQ87523, 12FT31106, 12LW96003, 12LW95993, 12FW28149, 03GF12612, 03GZ64035, 03GG13685, 03GF12688, 03FY07123, 03LC27402, 03KE26746, 03L67712, 03GG12986, 03GQ87755, 12LW95997, 03GX32031, 03LN36879, 03LX30575, 03GW37612, 03LX30710, 03GX83265, 03FQ38974, 03FY07105, 03GF12475, 03GF13578, 03FG43630, 03GP62664, 03K32476, 03GK83298, 03FY07271, 03GH65002, 03LJ31208, 03L67929, 03FG43872, 03KF17375, 03GL76134, 03LX28906, 03GF07667, 03GX30343, 03GR76627, 03K32654, 03FQ40705, 03FQ40965, 03G30286, 03FQ39578, 03LS28152, 03LM17305, 03H32665, 03E51657, 03KK38998, 03FL01551, 03L67868, 03GZ62881, 03G29398, 03FQ40407, 03GG13696, 03FG44786, 03LC28012, 03K32654, 03LE24152, 03FG30911, 03FG39791, 03GP56565, 03L57585, 03LR70982 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Degylcerolized Leukocytes Reduced 03H32073, 03FX36704 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced Irradiated 03FX40937, 03GZ58285, 03GP60292, 03KP31104, 03LN35475, 03E31964, 03LL42936, 03GQ64812, 03GQ64853, 03LM06932, 03LM06955, 03LM06939, 03KM30783, 03FJ78190, 03GZ60200, 03LG26883, 03GG11501, 03GC18533, 03LW36472, 03GQ85104, 03GS64808, 03GG12396, 03GM62356, 03FM18696, 03GH65126, 03GG12024, 03H32298, 03V35068, 03GP61483, 03LN36542, 03KK38669, 03FM18695, 03LN36338, 03GF10273, 03GY36394, 03GP61083, 03GY36474, 03GY36481, 03GT71418, 03GF11109, 03GG11962, 03GZ61268, 03LW36683, 03FM18552, 03FM18564, 03V30437, 03GZ46278, 03GF94284, 03KM26923, 03LN29189, 03GZ48681, 03KM28111, 03KE25986, 03GF04636, 03FW87722, 03FM18062, 03KM30529, 03LC20617, 03GJ72873, 03GY26074, 03LF17223, 03KK37509, 03LN35692, 03LX29294, 03LW36239 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced Washed 03FQ26098, 03GZ60333, 03GZ60422, 03LJ30937, 03KJ11915, 03FQ37815, 03GJ81099, 03L64530, 03FR58322, 03FQ36757, 03GF09106, 03GR75278, 03LN35780, 03FQ37298 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 03G27624, 11GY34647, 03GQ85121, 03GQ85170, 03GQ85172, 03GQ85177, 03L65065, 03P52879, 03P52879, 03FG42459, 03L65870, 03P52824, 03L63593, 03FG39664, 03LS27057, 03LS27057, 03P52004, 03FH25008, 03FG41042, 03FG41411, 03GQ85138, 03GQ85138 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells (Apheresis) Irradiated 03GQ85121, 03L65870, 03GQ85078, 03FG39664 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Washed 03L65716, 03GK66506, 03GZ34517, 03FF68869 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Frozen 03GS62958, 03H19479 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Deglycerolized 1723916683, 01GG51833, 1661214568, 17KS00548, 03LX29384 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated 03GC17653 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Rejuvenated Deglycerolized 116L93565 Class III Blood products, in which phenotype testing was performed incorrectly, were distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 084FT81025 Class II Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed. American National Red Cross (The)
Biologics Source Plasma 0300101489, 0300100390, 0300099622, 0300098831, 0300098638, 0300098192 Class III Blood products collected from a donor who was permanently deferred for unsuitable test results, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells Leukocytes Reduced GF57913 Class III Blood product, collected from a donor whose hematocrit was not recorded during donor screening, was distributed. Sacramento Medical Foundation
Biologics Red Blood Cells Leukocytes Reduced LG94546, FL10240, FL17948, GF11616, GF11748, GF20078, GF44114, GF48577, GF48588, GF48592, GF48593, LC50438, LC79204, LE01640, LG43958 Class II Blood products, for which the nucleic acid testing (NAT) for HIV/HCV was invalid, were distributed. Sacramento Medical Foundation
Biologics Platelets Pheresis Leukocytes Reduced Irradiated FM60475 Class III Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed. Sacramento Medical Foundation
Biologics Source Plasma 0300016826 Class III Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. Biomat USA, Inc.
Biologics Source Plasma 0300103488, 0300103018, 0300102415, 0300102273, 0300101776, 0300101195, 0300100547, 0300100278 Class II Blood products, collected from a donor who was previously deferred for IV drug use, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 006GV39770 (double unit) Class III Blood products, for which antigen testing was performed without documentation that a positive control was run, were distributed. American National Red Cross (The)
Biologics Source Plasma 06DTXC1449 Class II Blood products, collected from a donor with a history of high risk behaviors, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 006LR27406 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 006LR27406 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 006GE11777; 006GE11778; 006GE11749; 006GE11751; 006GE11740; 006GE11742; 006GE11781; 006GE11783; 006GE11790; 006GK32635; 006GK32636; 006GV41388; 006GK32645; 006GK32637; 006GE11792; 006GE11743; 006GE11784; 006GE11744; 006GE11747; 006GE11793; 006GE11791; 006GK32623; 006GE11794; 006GE11800; Class III Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed. American National Red Cross (The)
Biologics Source Plasma 06DTXA6690 Class II Blood product, collected from a donor with a history of high risk behaviors, was distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 05DTXC2105 Class III Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 006GK31728; 006LP10318 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 006LP10318 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 7538069; 7521442; 7538007; 7539276; 7539275; 7251452; 7538047 ; 7538061; 7536026; 7195746; 7251440; 7251444; 7538059; 7539267; 7533781 ; 7533797 ; 7532674; 7538022; 7195743; 7538044; 7251448; 7532670; 7538048 ; 7539259; 7539260; 7539273; 7538063; 7534707 ; 7251450; 7534690; 7195741; 7538042 ; 7533797; 7532674 Class III Blood products, which was labeled with an incorrect expiration date, were distributed. New York Blood Center,inc-cellular Therapy Laboratory
Biologics Red Blood Cells Leukocytes Reduced 5332241, 1652949 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. Blood Centers of the Pacific
Biologics Plasma Frozen 1652949 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. Blood Centers of the Pacific
Biologics Platelets Pheresis Leukocytes Reduced W045007912888 (split product) Class II Blood products, possibly contaminated with Propionibacterium species, were distributed. Community Blood Center of Greater Kansas City
Biologics Source Plasma 0650374191; 0650368067; 0650370713; 0650368716 Class III Blood products, collected from a donor who was previously deferred, were distributed. ZLB Bioplasma Services
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 7795181 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Coral Blood Services, Inc.
Biologics Fresh Frozen Plasma 7795181 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Coral Blood Services, Inc.
Biologics Source Plasma 0650394886; 0650393883; 0650392823; 0650392061; 0650391726; 0650390836; 0650390589; 0650390035; 0650389737; 0650388710; 0650388355; 0650377623; 0650372648; 0650370351; 0650369208 Class III Blood products, collected from a donor who was previously deferred, were distributed. ZLB Bioplasma Services
Biologics Blood and Blood Products for Reprocessing 6022546 Class II Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced 6022546 Class II Blood products, collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Blood Centers of the Pacific
Biologics Blood and Blood Products for Reprocessing 1573327 Class II Blood products, collected from an ineligible donor due to a history of hepatitis A, were distributed. Blood Centers of the Pacific
Biologics Red Blood Cells Leukocytes Reduced 1573327 Class II Blood products, collected from an ineligible donor due to a history of Hepatitis A, were distributed. Blood Centers of the Pacific
Biologics Source Plasma 8810004984; 8810004679; 8810003459; 8810003022; 8810002404; 8810002108; 8810001444; 8810000785; 0650400962; 0650400450; 0650399970; 0650399507; 0650399076; 0650398667; 0650397200; 0650395687; 0650395070; 0650394113; 0650393587; 0650393022 0650392267; 0650391219; 0650390824; 0650390398; 0650389986; 0650389522; 0650387509; 0650386070; 0650385686 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. ZLB Bioplasma Services
Biologics Source Plasma 8810000110; 0650399525 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. ZLB Bioplasma Services
Biologics Source Plasma 0650408894; 0650408560; 0650408033; 0650407608; 0650395167; 0650394845; 0650394191; 0650393836; 0650393124; 0650392894; 0650392008; 0650391643; 0650390956; 0650390627; 0650390114; 0650389762; 0650389229; 0650388641; 0650387778; 0650387219; 0650386749; 0650385836; 0650385151; 0650384726; 0650383924; 0650383176; 0650382994; 0650382393; 0650381850; 0650381296; 0650380871; 0650380501; 0650380058; 0650379600; 0650379146; 0650370924; 0650370636; 0650369893; 0650369586; 0650368902; 0650368182; 0650367515; 0650367082; 0650366309; 0650365927; 0650365317; 0650364503 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. ZLB Bioplasma Services
Biologics Source Plasma 0650404373; 0650402482; 8810005873; 8810005320; 8810004586; 8810003771; 8810003381; 8810002283; 8810001801; 8810001304; 8810000858; 8810000300; 0650399274; 0650398639; 0650398064; 0650397784; 0650396931; 0650396081; 0650395672; 0650395257; 0650394736; 0650394349; 0650393756; 0650393289; 0650392263; 0650391279 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. ZLB Bioplasma Services
Biologics Source Plasma 0650356688; 0650355904 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. ZLB Bioplasma Services
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W037708003337 Class II Blood product which did not meet the acceptable product specifications was distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells Leukocytes Reduced 1169359 Class II Blood products, collected from a donor at risk for human immunodeficiency virus (HIV) Group O, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Red Blood Cells Leukocytes Reduced Washed 2893099 Class II Blood products, collected from a donor at risk for human immunodeficiency virus (HIV) Group O, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Platelets Leukocytes Reduced 2893099 Class II Blood products, collected from a donor at risk for human immunodeficiency virus (HIV) Group O, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Cryoprecipitated AHF 1169359 Class II Blood products, collected from a donor at risk for human immunodeficiency virus (HIV) Group O, were distributed. Hoxworth Blood Center University of Cincinnati Medical Center
Biologics Source Plasma 08AOHB2829 Class II Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced 1643639 Class II Blood products, which were collected from a donor with a history of high risk behaviors, were distributed Blood Centers of the Pacific
Biologics Blood and Blood Products for Reprocessing 1643639 Class II Blood products, which were collected from a donor with a history of high risk behaviors, were distributed Blood Centers of the Pacific
Biologics Cryoprecipitated AHF, Pooled 1622456 Class II Blood products, which were collected from a donor with a history of high risk behaviors, were distributed Blood Centers of the Pacific
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 50KG13297 (Part A); 50KG13297(Part B) Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 24KY89935 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 24KY89935 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Drugs Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10. Lot #: : PUB1040, Exp 08/2015 Class III Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels. Pack Pharmaceuticals
Food Probitotic Dietary Supplement. : iFlora® Kids Multi-Probiotic® Lot numbers: 1595811, 2089411, 1074711, 1479611, 1640811 and 1734411. UPC codes: 6 48575 01013 2 and 6 48575 01014 9 UPC Codes: 6 48575 01013 2 6 48575 01013 2 6 48575 01013 2 6 48575 01013 2 Class I On the evening of Friday, July 6, 2012, Ingredion, Inc. (f/k/a Corn Products U.S., Inc.) the supplier of Galactooligosaccharide (GOS), an ingredient included, in iFlora® Kids Multi Probiotic, notified our contract manufacturer that two lots of their GOS material supplied for inclusion in our products were being recalled for a suspected salmonella contamination. Although our contract manufacturer tested each lot of iFlora® Kids Multi Probiotic and confirmed that our products tested free of salmonella, in compliance with the suppliers recall and in an abundance of caution, we immediately contacted the FDA and initiated a full recall of our iFlora® Kids Multi Probiotic products. Nutri-Health Supplements Llc.
Biologics Platelet Pheresis Leukocytes Reduced Part 1 of 2 and 2 of 2 9684969 (part 1 of 2 and part 2 of 2); 9764768 (part 1 of 2 and part 2 of 2); 9765357 (part 1 of 2 and part 2 of 2); 9771884 (part 1 of 2 and part 2 of 2); 9763523 (part 1 of 2 and part 2 of 2); 9745447 (part 1 of 2 and part 2 of 2); 9761407 (part 1 of 2 and part 2 of 2); 9755010 (part 1 of 2 and part 2 of 2); 8721317 (part 1 of 2 and part 2 of 2); 7396779 (part 1 of 2 and part 2 of 2); 7385402 (part 1 of 2 and part 2 of 2); 7392161( part 1 of 2 and part 2 of 2); 8728456 (part 1 of 2 and part 2 of 2); 8729268 (part 1 of 2 and part 2 of 2); 8723646 (part 1 of 2 and part 2 of 2); 8676244 (part 1 of 2 and part 2 of 2) ; 8714796 (part 1 of 2 and part 2 of 2) ,8636458 (part 1 of 2 and part 2 of 2) Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Florida's Blood Centers, Inc.
Biologics Platelet Pheresis Leukocytes Reduced 9684754; 9684518; 9752702; 8698337, 8702797 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Florida's Blood Centers, Inc.
Biologics Fresh Frozen Plasma Apheresis 9684518 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Florida's Blood Centers, Inc.
Biologics Red Blood Cells Leukocytes Reduced 8889461 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Florida's Blood Centers, Inc.
Biologics Platelet Pheresis Leukocytes Reduced, Part 1 of 3, Part 2 of 3 and Part 3 of 3 9767339 (part 1 of 3, part 2 of 3 and part 3 of 3); 8699301 (part 1 of 3, part 2 of 3 and part 3 of 3) Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Florida's Blood Centers, Inc.
Biologics Platelet Pheresis Leukocytes Reduced Irradiated, Part 1 of 2 and 2 of 2 8653461 part 1 of 2; 8653461 part 2 of 2 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma 3910033240, 3910033563, 3910034006, 3910034606, 3910034904, 3910035616, 3910036108, 3910037104, 3910037562, 3910038424, 3910027760, 3910028565, 3910029245, 3910029574, 3910029989, 3910030620, 3910031233, 3910031841, 3910038818, 3910039534, 3910039935, 3910040469, 3910040764, 3910041381, 3910041978, 3910042585, 3910042922, 3910043521, 3910043981, 3910044562, 3910045247, 3910045709, 3910046403, 3910046846, 3910047487, 3910047904, 3910048606, 3910049106, 3910049787, 3910050258, 3910050994, 3910051397, 3910052184, 3910052499, 3910053143, 3910053569, 3910054248, 3910054864, 3910055356, 3910056086, 3910056517, 3910058281, 3910058641, 3910060577, 3910060963, 3910061663, 3910062228, 3910062587, 3910063206, 3910063680, 3910064380, 3910064867, 3910065496, 3910065987, 3910067028, 3910067716, 3910068043, 3910068965, 3910069353, 3910069903, 3910070511, 3910070969, 3910071485, 3910071805, 3910072399, 3910072857, 3910073547, 3910074099 Class II Blood products, collected from a donor who had a tattoo within 12 months of donation, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma KZ093177, KZ093135, KZ092908, KZ092716, KZ092621, KZ091982, KZ091873, KZ091343, KZ091178, KP120886, KP120695, KZ090502, KZ090239, KZ090027, KZ089767, KZ089581, KZ089348, KZ088977, KZ088855, KZ088519, KZ088268, KZ088001, KZ087749, KZ087448, KZ087211, KZ086953, KP119761, KZ086135, KZ085863, KZ085596, KP119597, KZ085128, KZ084906, KZ084736, KZ084458, KZ084185, KP119264, KZ083698, KZ083393, KZ083126, KZ082812, KZ082251, KZ082005, KZ081742, KZ081293, KZ081035, KZ080737, KZ080209, KZ080077, KZ079836, KZ079567, KZ079266, KZ078722, KZ078489, KP118373, KZ077856, KZ077523, KZ077316, KZ076953, KZ076779, KZ076400, KZ076230, KZ076005, KZ075736, KZ075509, KZ075237, KZ074968, KZ074724, KZ074474, KZ074114, KZ073974, KZ073616, KZ073457, KZ073065, KZ072969, KZ072575, KZ072427, KZ072116, KZ071897, KZ071487, KZ070972, KZ070692, KZ070380, KP117144 Class III Blood products, collected from a donor who was previously deferred, were distributed. Plasma Biological Services Inc
Biologics Source Plasma 3910082101; 3910082598; 3910082906; 3910085911; 3910086807; 3910081900; 3910081503; 3910081868; 3910082275; 3910082774; 3910083156; 3910083903; 3910084951; 3910085815; 3910086223; 3910080955; 3910081305; 3910081712; 3910082232; 3910082762; 3910083137; 3910083887; 3910084221; 3910084617; 3910084939; 3910085447; 3910085791; 3910086679; 3910047776; 3910043408; 3910042108; 3910038442; 3910037785; 3910037362; 3910036416; 3910035164; 3910034679; 3910032818; 3910029232; 3910028845; 3910027896; 3910027430; 3910026492; 3910024632; 3910023541; 3910022087; 3910021589; 3910020014; 3910018908; 3910018439; 3910017446; 3910017013; 3910015987; 3910015521; 3910014524; 3910014092; 3910013152; 3910012673; 3910011604; 3910010577; 3910010196; 3910009286; Class II Blood products, collected from a donor whose routine physical examination was inadequately performed, were distributed. Talecris Plasma Resources, Inc.
Biologics Fresh Frozen Plasma (Apheresis) W04121100687200R,W04121100687200R, W04121100687200R, W04121100687200R, W041211006911008, W041211006911008, W04121100694100X, W04121100694100X, W04121100694100X, W04121100694100X, W04121100696700D, W04121100696700D, W04121102271100O, W04121102271100O, W04121102271100O, W04121102271100O, W04121102400900*, W04121102400900*, W04121102400900*, W04121102400900*, W04121102419600Z, W04121102419600Z, W04121102419600Z, W04121102419600Z, W04121103027400Y, W04121103027400Y, W04121103027400Y, W04121103027400Y Class III Blood product, manufactured with lactated ringer's solution instead os normal saline, was distributed. Blood Systems, Inc.
Biologics Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO@ See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" .25-.5mm 15cc Cancellous Chips, Product Code 0306Al Tissue ID/Donor ID# Al1000082005 and Al1000082006 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" .5-1mm 15cc, 30cc, and 1cc Cancellous Chips: Product Code 0308Al, .5-1mm 15cc Cancellous Chips Product Code 0309AI, .5-1mm 30cc Cancellous Chips Product Code 0326AI, .5-1mm 1cc Cancellous Chips Tissue ID/Donor ID# Al1000082007, Al1000082008, Al1000082009, Al1000082010, Al1000082011, Al1000112020, Al1000112021, Al1000112022, Al1000112023, Al1000112024, Al1000112025, Al1000112026, Al1000112027, Al1000112028, Al1000112029 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" 1-4mm 15cc, 30cc, and 60cc Cancellous Chips Product Code 0310Al, 1-4mm 15cc Cancellous Chips Product Code 0311AI, 1-4mm 30cc Cancellous Chips Product Code 0313AI, 1-4mm 60cc Cancellous Chips Tissue ID/Donor ID: Al1000082012, Al1000082013, Al1000082014, Al1000082015, Al1000082016, Al1000082017, Al1000082018, Al1000082019, Al1000082020, Al1000082021, Al1000082022, Al1000082023, Al1000112014, Al1000112015, Al1000112016, Al1000112017, Al1000112018, Al1000112019 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Cancellous Chips. Product is labeled in part: "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #:***cc Cancellous Chips***Size:***mm***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" 4-10mm 15cc, 30cc, and 60cc Cancellous Chips: Product Code 0317AI, 4-10mm 15cc Cancellous Chips Product Code 0318Al, 4-10mm 30cc Cancellous Chips Product Code 0320Al. 4-10mm 60cc Cancellous Chips Tissue ID/Donor ID: Al1000082024, Al1000082025, Al1000082026, Al1000082027, Al1000082028, Al1000082029, Al1000112030, Al1000112005, Al1000112006, Al1000082031, Al1000082032, Al1000082033, Al1000082034, Al1000112007, Al1000112008, Al1000112009, Al1000112010, Al1000112011, Al1000112012, Al1000112013 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Achilles with Bone Block. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 0201Al Donor#/Tissue ID# A1000110005 and Al1000110006 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Patella Hemi. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 1901Al Donor#/Tissue ID# A1000110008 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Patella Hemi Pre-Sized. "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 1903Al Donor#/Tissue ID# A1000110009 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Tibialis Anterior "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 2701Al Donor#/Tissue ID# A1000110010 and A1000110011 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Tibialis Posterior "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 2702Al Donor#/Tissue ID# A100011-0012 and A100011-0013. Donor#/Tissue ID# A1000110012 and A1000110013 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Biologics Peroneous Longus "***Allograft INNOVATIONS***DuraGraft***3542 NW 97th Blvd. Gainesville, FL 32606 Phone: 877-507-3582 Fax: 352-333-6925***Tissue ID #:***Donor ID #:***Exp. Date:***Re-Order #***Store At: Room Temperature Freeze Dried***Sterilization Method: Supercritical CO2 See Package Insert***DONATED HUMAN TISSUE FOR SINGLE PATIENT/SURGERY USE ONLY***" Product Code 2101Al Donor#/Tissue ID# A1000110014 and A1000110015 Class II Human allografts, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Allograft Innovations, LLC
Veterinary Nature Wise CHICK STARTER GROWER 18% CRUMBLES (LL), 91577-25LL 1110, NET WEIGHT 25 LB (11.33 kg), UPC: 722304275631 and 91577LL, NET WEIGHT 50 LB (22.67 kg), UPC: none, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440 date codes: 4K1249 through 4K1335; actual date codes distributed: 1200, 1202, 1207, 1221, 1229, 1230, 1236, 1266, 1319 Class I Animal feeds may have Aflatoxin levels above the legal limit. Cargill Inc Animal Nutrition Division
Veterinary Nature Wise MEAT BIRD 22% CRUMBLES (LL), 91585-40LL, NET WEIGHT 40 LB (18.14 kg), UPC: 722304275754 and 91585 LL 1101, NET WEIGHT 50 LB (22.67 kg), UPC: none, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440 date codes: 4K1249 through 4K1335; actual date codes distributed: 1182, 1194, 1199, 1235, 1236, 1277, 1326 Class I Animal feeds may have Aflatoxin levels above the legal limit. Cargill Inc Animal Nutrition Division
Veterinary DUMOR(R) CHICK STARTER/GROWER 20% CR (LL), 93971 LL, NET WEIGHT 20 LB (9.07 kg), UPC: 749394067411 and 93978 LL 1006, NET WEIGHT 50 LB (22.67 kg), ON BAG OR BULK, UPC: 749394067404, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027 date codes: 4K1249 through 4K1335; actual date codes distributed: 1193, 1234 Class I Animal feeds may have Aflatoxin levels above the legal limit. Cargill Inc Animal Nutrition Division
Veterinary DUMOR(R) POULTRY GRO/FINISH 15% (LL), 93975 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027, UPC: 749394067374 date codes: 4K1249 through 4K1335; actual date code distributed: 1192 Class I Animal feeds may have Aflatoxin levels above the legal limit. Cargill Inc Animal Nutrition Division
Veterinary Nutrena(R) NATUREWISE(R) CRACKED CORN (25#) (LL) 91868-25 LL1006, NET WEIGHT 25 LB (11.33 kg), UPC: 722304029036 and 91868 LL, NET WEIGHT 50 LB (22.67 kg), UPC: 72230429036, NUTRENA, GENERAL OFFICE, MINNEAPOLIS, MN 55440 date codes: 4K1249 through 4K1335; actual date codes distributed: 1159, 1195, 1196, 1201, 1209, 1210, 1216, 1222, 1224, 1229, 1230, 1237, 1264, 1265, 1301, 1318, 1326 Class I Animal feeds may have Aflatoxin levels above the legal limit. Cargill Inc Animal Nutrition Division
Veterinary Producer's PRIDE CRACKED CORN (LL), 93951 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027, UPC: 750889222030 date codes: 4K1249 through 4K1335; actual date code distributed: 1202 Class I Animal feeds may have Aflatoxin levels above the legal limit. Cargill Inc Animal Nutrition Division
Veterinary Producers's PRIDE WHOLE CORN (LL), 93952 LL, NET WEIGHT ON BAG OR BULK, DISTRIBUTED BY: TRACTOR SUPPLY COMPANY, 200 POWELL PLACE, BRENTWOOD, TN 37027, UPC: 749394016333 date codes: 4K1249 through 4K1335; actual date code distributed: 1182 Class I Animal feeds may have Aflatoxin levels above the legal limit. Cargill Inc Animal Nutrition Division
Veterinary ACCO FEEDS(R) SHOWMASTER(R) CALF GROWER (B13.6) (LL) MEDICATED, 10568-B LL , NET WEIGHT ON BAG OR BULK, ACCO FEEDS, GENERAL OFFICE, MINNEAPOLIS, MN 55440, UPC: 722304042103 date codes: 4K1249 through 4K1335; Actual date codes distributed: 1208, 1229, 1257, 1278, 1305, 1333 Class I Animal feeds may have Aflatoxin levels above the legal limit. Cargill Inc Animal Nutrition Division
Devices epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system Catalog #CT-1004-00-00, lot number 07-11087-00 Class II Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results. Epocal Inc
Devices Etac® Ono Walker, Etac® Avant Walker, and Etac® Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG. Model numbers: 15030102-15, 15030103-15 , 15030202-15, 15030403-15 , 15031003-14, 15040105-14, 15040105-33, 15040301-14, 15040301-33, and 15110101-18. Class II The recall has been initiated because there is the potential that users may fall and become injured, with the potential for serious injury, including bone fracture. One death occurred in a user fall incident, but it is unclear whether the fall was caused by the loss of a wheel. Among the walkers distributed worldwide, Etac® has received a total of 49 reports from Europe and Japan of wheels falling off the walkers. No incidents have been reported in the United States. Etac® is recalling the Etac® Ono and Etac® Avant model walkers that were distributed in the United States between January 2002 and December 2011 and the Etac® Salsa model walkers that were distributed in the United States between January 2006 and December 2011. A total of 637 Ono, 2,858 Avant, and 175 Salsa walkers have been distributed in the U.S. market. The recall includes all Ono walkers with serial numbers preceding 223,000, and all serial numbers of Avant and Salsa walkers. Etac Supply Center Ab
Devices Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Catalog Number 801763 and serial number 0011-1450 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Catalog Number 801764 and serial number 0006-1441 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (oversensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number 16400 and serial number 1001-1333 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number 16401 and serial number PT003, 1001-3001 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number 16405 and serial number 1001-1461 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number 16406 and serial number 1001-1823 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number 16409 and serial number 1001-1026 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number 16410 and serial number 1001-1622 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Catalog Number 164300 and serial number 1006-5462 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Catalog Number 164290 and serial number 1005-5463 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Devices Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. Catalog Number 164280 and serial number 1019-5379 Class II Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in systems that were distributed after the corrective actions had been implemented. Terumo Cardiovascular Systems Corporation
Drugs Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30 Lot #10830LL, Exp. 1APR2013 Class I Superpotent; Cartridges labeled to contain 1 mL found to contain 2.2 mL Hospira Inc.
Drugs Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30 Lot 249814 Samples Lot 249816 samples Lot 260393 exp 4/30/20012 Lot 255345 exp 11/30/2011 Lot 000001 exp 8/31/2012 Lot 261827 exp 5/31/2012 Lot 50004 exp 11/30/2012 Lot 50005 exp 11/30/2012 Lot 500007 exp 12/31/2012 Lot 000002 exp 9/30/20012 Class II Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP. Meda Pharmaceuticals Inc.
Devices SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters. All versions Class III Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices. Sigma
Drugs Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25 Lot #1395 Exp: July 2012 Class II Presence of Particulate Matter Luitpold Pharmaceuticals, Inc.
Devices Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and intended to measure the height of the disc space intra-operatively. Class I; 510(k) Exempt Description: AVS® Navigator Trials. Size 6mm -15mm. Catalog Number: 48392206,48392207,48392208,48392209,48392210, 48392211,48392212,48392213,48392214,48392215. Lot Code: 104864,104866, 104867, 104868, 104869, 104870, 10E331, 104871, 104872, 104873, 104874, 104875. Class II Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head. Stryker Spine
Devices System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number: 801763 and Serial Numbers: 0011-0335,0337-0610,1001- 1034,1037-1049,1100,1103-1106,1109-1445, and 1447-1450. Class II Terumo® Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or fluctuation of internal power on one side of the system base include: " Loss of function of any module, including pumps " Loss of safety systems " Loss of ability to control the gas blender through the CCM; NOTE: in this case, the user can control the gas blender locally Terumo Cardiovascular Systems Corporation
Devices System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog Number: 801764 and Serial numbers: 0006-0066, 01 00-0311, 0313-0322,1001-1027,1100-1434,1436, 1440, and 1441. Class II Terumo® Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons indicating a loss or fluctuation of internal power on one side of the system's base. Terumo Cardiovascular Systems' initial investigation has determined that there may be more than one cause for the malfunction and is investigating further to determine the root cause. Potential risks with the loss or fluctuation of internal power on one side of the system base include: " Loss of function of any module, including pumps " Loss of safety systems " Loss of ability to control the gas blender through the CCM; NOTE: in this case, the user can control the gas blender locally Terumo Cardiovascular Systems Corporation
Devices Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 801763 and serial number: 0011-0335,0337-0610, 1001-1034, 1037-1049,1100, 1103-1106, 1109-1445,and 1447-1450. Class II Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The failure of a pump or module to power on, or to lose power after powering on The loss or fluctuation of power or communication in the system network can result in a variety of potential hazards, depending on the system's user-determined configuration. Potential hazards include: " Loss of function of one or multiple modules, including pumps " Loss of one or multiple safety systems " Loss of ability to control the gas blender through the CCM. Terumo CVS is notifying users because the Operators Manual for the Terumo System 1 does not contain sufficient instruction for responding to these issues. As an interim precaution, Terumo CVS is informing users of Terumo System 1 of the risks associated with these failures and providing additional instruction. Terumo Cardiovascular Systems Corporation
Devices Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 801764 and serial number: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436,1440, and 1441. Class II Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as communications or power failures in the system network for Terumo Advanced Perfusion System 1. Issues that affect a single pump or module are: " The appearance of a red X on a single pump or module icon on the CCM " The appearance or a single '?' symbol on a pump or module icon on the CCM " The failure of a pump or module to power on, or to lose power after powering on The loss or fluctuation of power or communication in the system network can result in a variety of potential hazards, depending on the system's user-determined configuration. Potential hazards include: " Loss of function of one or multiple modules, including pumps " Loss of one or multiple safety systems " Loss of ability to control the gas blender through the CCM. Terumo CVS is notifying users because the Operators Manual for the Terumo System 1 does not contain sufficient instruction for responding to these issues. As an interim precaution, Terumo CVS is informing users of Terumo System 1 of the risks associated with these failures and providing additional instruction. Terumo Cardiovascular Systems Corporation
Devices BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. Lot 1348873, Exp April 30, 2013 Class II Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci. Becton Dickinson & Co.
Devices Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. Lots 1325324 Exp May 31,2013 and 2011746, Exp July 31,2013 Class II Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci. Becton Dickinson & Co.
Food Old Fashioned Foods, Jalapeno Bean Dip, Ingredients: water, pinto beans, partially hydrogenated soybean oil, red bell pepper, jalapeno peppers, salt, dehydrated onions, green bell peppers, sorbic acid (as a preservative), vinegar, citric acid, paprika, ,pepper flavor, gallic powder,Net WT, 3 oz (86g), MFG by Old Fashioned Foods, Mayville, WI, 53050 Sell by 11 SEPT2013 -Jalapeno Bean Dip Item #43335 Class II Old Fashioned Foods Inc is recalling Zesty Bean Dip and Jalapeno Bean Dip because of inadequate processing according to 21CFR114, acidified food regulations. Old Fashioned Foods, Inc.
Food Abbott Acres, Meal Pals, Zesty Bean Dip, Ingredients: water, pinto beans, soybean oil, tomato paste, less than 2% sugar, , salt jalapeno peppers, dehydrated onions, vinegar, sorbic acid (as a preservative), citric acid, caramel color, FD&C yellow #5, paprika, red bell pepper, sodium benzoate (as a preservative), pepper concentrate, gallic powder, Net WT 3 0z ( 85 g), Dist by JA Foodservice, Buchanan, MI 49107 Best By 14 MAR2013 - Zesty Bean Dip Item# 42193 Best By 09 APR 2013 (not distributed) Class II Old Fashioned Foods Inc is recalling Zesty Bean Dip and Jalapeno Bean Dip because of inadequate processing according to 21CFR114, acidified food regulations. Old Fashioned Foods, Inc.
Veterinary 5 LB Natural Balance Sweet Potato & Venison Dog UPC# 7-23633-88650-5 UPC# 7-23633-88650-5, Lot Code NBH1202 Best By Date: December 12, 2012; December 13, 2012. Lot Code NBH0103 Best By Date: March 13, 2013. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 15 LB Natural Balance Sweet Potato & Venison Dog UPC# 7-23633-88615-4, Lot Code NBH0101 Best By Date: March 5, 2013; March 6, 2013. Lot Code NBH1202 Best By Date: December 12, 2012; December 13, 2012. Lot Code NBH1203 Best By Date: December 13, 2012; December 14, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 28 LB Natural Balance Sweet Potato & Venison Dog UPC# 7-23633-88628-4, Lot Code NBH0101 Best By Date: March 5, 2013; March 6, 2013. Lot Code NBH0102 Best By Date: March 7, 2013; March 8, 2013. Lot Code NBH0103 Best By Date: March 12, 2013. Lot Code NBH1202 Best By Date: December 12, 2012; December 13, 2012. Lot Code NBH1203 Best By Date: December 13, 2012; December 14, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 5 LB Natural Balance Lamb Meal & Brown Rice Dog UPC# 7-23633-78755-0, Lot Code NBR1202 Best By Date: December 10, 2012. Lot Code NBR1203 Best By Date: December 21, 2012; December 22, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 15 LB Natural Balance Lamb Meal & Brown Rice Dog UPC# 7-23633-78715-4, Lot Code NBR1202 Best By Date: December 10, 2012; Lot Code NBR1203 Best By Date: December 21, 2012; December 22, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 28 LB Natural Balance Lamb Meal & Brown Rice Dog UPC# 7-23633-78728-4, Lot Code NBR1202 Best By Date: December 10, 2012; Lot Code NBR1203 Best By Date: December 21, 2012; December 22, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 5 LB Natural Balance Sweet Potato & Bison Dog UPC# 7-23633-65553-8, Lot Code NBT1202 Best By Date: December 17, 2012; December 18, 2012; Lot Code NBT1203 Best By Date: December 28, 2012; December 29, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 15 LB Natural Balance Sweet Potato & Bison Dog UPC# 7-23633-61718-5, Lot Code NBT1201 Best By Date: December 9, 2012; Lot Code NBT1202 Best By Date: December 17, 2012; December 18, 2012; Lot Code NBT1203 Best By Date: December 28, 2012; December 29, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 28 LB Natural Balance Sweet Potato & Bison Dog UPC# 7-23633-63031-3, Lot Code NBT1201 Best By Date: December 9, 2012 Lot Code NBT1202 Best By Date: December 17, 2012; December 18, 2012; Lot Code NBT1203 Best By Date: December 28, 2012; December 29, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 5 LB Natural Balance Vegetarian Dog UPC# 7-23633-80855-2, Lot Code NBV1201 Best By Date: December 9, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 28 LB Natural Balance Lamb Meal & Brown Rice Dog Large Breed Bites UPC# 7-23633-44443-9, Lot Code NLB1202 Best By Date: December 12, 2012; Lot Code NLB1203 Best By Date: December 20, 2012; December 21, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 5 LB Natural Balance Lamb Meal & Brown Rice Dog Small Breed Bites UPC# 7-23633-42300-7, Lot Code NSL1201 Best By Date: December 21, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary 12.5 LB Natural Balance Lamb Meal & Brown Rice Dog Small Breed Bites UPC# 7-23633-42301-4, Lot Code NSL1201 Best By Date: December 21, 2012. Class I The recall was initiated because Natural Balance Pet Foods has confirmed that certain dry pet food formulas manufactured by Diamond Pet Foods may be contaminated with Salmonella. Natural Balance Pet Food Inc.
Veterinary PROIN 75MG COUNT BOTTLES HAVE THE CORRECT BASE LABEL OF: "***PROIN 75 mg (phenylpropanolamine hydrochloride) CHEWABLE TABLETS 75 mg per tablet***For oral use in dogs only***60 tablets***CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.***Sympathomimetic amine drug***NADA #141-324, Approved by FDA***PRN PHARMACAL Pegasus Laboratories, Inc.***Each scored tablet contains 75 mg phenylpropanolamine, as hydrochloride.***Indications: PROIN is indicated for the control of urinary incontinence due to urethral sphincter hypotonus in dogs.***Dosage: The total recommended dosage for oral administration is 2mg/kg (0.91 mg/lb) of body weight twice daily. Tablets are scored and dosage should be calculated in half-tablet increments.***Warnings: Keep out of reach of children. Not for human use. Consult a physician in case of accidental ingestion by humans. For use in dogs only.***Precautions: PROIN Chewable Tablets should be stored out of reach of dogs in a secured area.***Manufactured by: Pegasus Laboratories, Inc. An Employee-Owned Company Pensacola, FL 32514, USA***Made in USA***" INCORRECT BOOKLET TOP LABEL IS A PROIN 25MG LABEL. INSERT/BOOKLET LABELING THAT MAY BE ON PROIN 75 mg 60 COUNT BOTTLES: "***PROIN 25 mg (phenylpropanolamine hydrochloride) CHEWABLE TABLETS 25 mg per tablet***For oral use in dogs only***60 tablets***CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.***Sympathomimetic amine drug***NADA #141-324, Approved by FDA***PRN PHARMACAL Pegasus Laboratories, Inc.***Warnings: Keep out of reach of children. Not for human use. Consult a physician in case of accidental ingestion by humans. For use in dogs only.***Precautions: PROIN Chewable Tablets should be stored out of reach of dogs in a secured area.***Manufactured by: Pegasus Laboratories, Inc. An Employee-Owned Company Pensacola, FL 32514, USA***Made in USA***" CORRECT BOOKLET TOP LABEL IS A PROIN 75 MG LABEL. INSERT/BOOKLET LABELING THAT SHOULD BE ON PROIN 75 mg 60 COUNT BOTTLES: "***PROIN 75 mg (phenylpropanolamine hydrochloride) CHEWABLE TABLETS 75 mg per tablet***For oral use in dogs only***60 tablets***CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.***Sympathomimetic amine drug***NADA #141-324, Approved by FDA***PRN PHARMACAL Pegasus Laboratories, Inc.***Warnings: Keep out of reach of children. Not for human use. Consult a physician in case of accidental ingestion by humans. For use in dogs only.***Precautions: PROIN Chewable Tablets should be stored out of reach of dogs in a secured area.***Manufactured by: Pegasus Laboratories, Inc. An Employee-Owned Company Pensacola, FL 32514, USA***Made in USA***" Lots: 120213 and 120416 Class II Pegasus Laboratories, Inc. is recalling 75 mg, 60 count bottles of Proin Lots 120416 and 120213 for misbranding. The affected product has the potential to have a 75mg base label with a 25mg Insert attached to the label. Proin is a veterinary drug used to treat incontinence in dogs. Pegasus Laboratories, Inc.
Drugs Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 NAA04K6 Exp. 09/13, NAA055P Exp. 09/13, NAA05PA Exp. 09/13 Class III Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton. Bayer Healthcare, LLC
Drugs Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct. blister, Distributed by Bayer Health Care, Morristown, NJ 07962 (NDC 0280-8005-25) NAA055N Exp.12/13, NAA05PC Exp.12/13, NAA0462 Exp.12/13 Class III Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of capsules/caplets that should be taken within a 24-hour period, does not match the statement on the carton. Bayer Healthcare, LLC
Drugs Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02 Lot 231423, 255867 Class III Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20° to 25°C (68° to 77°F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20° to 25°C (28° to 77°F)". JHP Pharmaceuticals, LLC
Devices EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent. The Kit MACH4 is labeled in parts: "***EkoSonic MACH4 Endovascular Device***MicroSonic Device and Intelligent Drug Delivery Catheter***". The Pouch MSD is labeled in parts: "***EKOS***MicroSonic Device***Sterile***". EkoSonic Endovascular System is a catheter, continuous infusion. It is intended for the controlled and selective infusion of physician-specific fluids, including thrombolytics, into the peripheral vasculature. The system is also intended for the infusion of solutions into pulmonary arteries. Serial Numbers: 090220013-001; 090323005-001; 090415007-001; 090416010-003; 090421002-001; 090421002-003; 090422005-001; 090422005-002; 090422005-004; 090422006-001; 090422006-002; 090422006-003; 090422006-004; 090422006-005; 090422006-006; 090422007-005; 090423002-001; 090423006-001; 090423006-002; 090423007-001; 090423007-002; 090423007-003; 090423007-004; 090423007-005; 090423007-006; 090423007-007; 090423008-001; 090423008-002; 090423008-003; 090423008-004; 090423008-005; 090423008-006; 090423008-008; 090427001-001; 090427001-002; 090427001-003; 090427001-004; 090427001-005; 090427006-003; 090427006-004; 090427007-001; 090427007-002; 090427008-001; 090427008-002; 090427008-003; 090428006-001; 090428006-002; 090428007-001; 090428008-004; 090428008-005; 090428008-006; 090429004-001; 090429004-002; 090429004-003; 090429004-004; 090429004-005; 090429004-006; 090429005-002; 090429006-001; 090429006-002; 090429011-002; 090429011-004; 090429011-005; 090429021-001; 090429021-002; 090429021-003; 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Class II EKOS Corporation have recently received several complaints from users where the radio-opaque marker bands on the Intelligent Drug Delivery Catheter (IDDC) were dislodged during a procedure and report of MicroSonic Device (MSD) breaking during insertion or operation. EKOS Corporation
Devices Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator. Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Class II On 05/23/2012, Stingray Surgical Products, LLC., Boca Raton, FL initiated a recall initiated due to "Instructions For Use" of Bipolar Forceps not being cleared by FDA and incorrect "Instructions For Use" . The sterilization instructions have been altered without the clearance of the FDA. Stingray Surgical Products, LLC
Devices Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures. Code information is listed as Catalogue Number, Description and Lot Number (K Number) and is as follows: Catalog No. Description Lot No. 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K948548 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K102535 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K141824 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K155506 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K114992 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K395488 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K105496 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K923725 18291104S Arthrodesis Nail, LEFT Ø11.5 x 540mm K252636 18291108S Arthrodesis Nail, LEFT Ø11.5 x 580mm K137348 18291108S Arthrodesis Nail, LEFT Ø11.5 x 580mm K965902 18291108S Arthrodesis Nail, LEFT Ø11.5 x 580mm K695563 18291108S Arthrodesis Nail, LEFT Ø11.5 x 580mm K857453 18291108S Arthrodesis Nail, LEFT Ø11.5 x 580mm K862864 18291108S Arthrodesis Nail, LEFT Ø11.5 x 580mm K739588 18291108S Arthrodesis Nail, LEFT Ø11.5 x 580mm K245215 18291108S Arthrodesis Nail, LEFT Ø11.5 x 580mm K228300 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K219678 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K237017 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K133228 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K128489 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K960393 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K178967 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K923723 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K243246 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K252638 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K224305 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K172103 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K117496 18291112S Arthrodesis Nail, LEFT Ø11.5 x 620mm K261302 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K210496 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K189318 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K161024 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K255675 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K249773 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K206467 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K163054 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K153010 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K133229 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K129741 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K551191 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K579446 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K718554 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K395487 18291116S Arthrodesis Nail, LEFT Ø11.5 x 660mm K241618 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K221660 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K206470 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K133230 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K547010 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K477263 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K971898 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K862865 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K283864 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K395485 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K605002 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K207158 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K149929 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K114002 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K233828 18291120S Arthrodesis Nail, LEFT Ø11.5 x 700mm K869700 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K130896 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K784981 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K551192 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K579447 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K289448 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K177753 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K293136 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K250375 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K182394 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K269022 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K210938 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K166292 18291124S Arthrodesis Nail, LEFT Ø11.5 x 740mm K137364 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K579449 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K397977 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K890907 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K172104 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K130675 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K298308 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K186902 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K153008 18291128S Arthrodesis Nail, LEFT Ø11.5 x 780mm K130897 18291154S Arthrodesis Nail, RIGHT Ø11.5 x 540mm K264288 18291154S Arthrodesis Nail, RIGHT Ø11.5 x 540mm K113029 18291154S Arthrodesis Nail, RIGHT Ø11.5 x 540mm K286419 18291154S Arthrodesis Nail, RIGHT Ø11.5 x 540mm K250373 18291154S Arthrodesis Nail, RIGHT Ø11.5 x 540mm K183343 18291154S Arthrodesis Nail, RIGHT Ø11.5 x 540mm K153007 18291154S Arthrodesis Nail, RIGHT Ø11.5 x 540mm K984759 18291154S Arthrodesis Nail, RIGHT Ø11.5 x 540mm K972226 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K169101 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K154907 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K140784 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K482337 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K264256 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K739432 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K931618 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K144840 18291158S Arthrodesis Nail, RIGHT Ø11.5 x 580mm K109854 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K923722 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K395490 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K114993 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K252640 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K177754 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K149931 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K250372 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K138344 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K129743 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K409129 18291162S Arthrodesis Nail, RIGHT Ø11.5 x 620mm K844007 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K870887 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K109958 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K237890 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K258328 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K923718 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K248395 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K276178 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K276181 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K177755 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K119469 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K190445 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K173143 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K172578 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K124572 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K695562 18291166S Arthrodesis Nail, RIGHT Ø11.5 x 660mm K857462 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K177756 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K169979 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K149930 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K253421 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K212596 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K205529 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K194207 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K171314 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K147167 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K132491 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K952957 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K845196 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K710256 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K669610 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K412352 18291170S Arthrodesis Nail, RIGHT Ø11.5 x 700mm K984763 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K394348 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K395492 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K890909 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K218356 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K206748 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K181988 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K119468 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K250371 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K171315 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K154906 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K138347 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K126931 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K822867 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K941271 18291174S Arthrodesis Nail, RIGHT Ø11.5 x 740mm K879170 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K739428 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K113093 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K843328 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K299898 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K289452 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K207160 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K292169 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K257592 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K181110 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K175468 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K133244 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K679111 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K668032 18291178S Arthrodesis Nail, RIGHT Ø11.5 x 780mm K468440 18291304S Arthrodesis Nail, LEFT Ø13 x 540mm K179514 18291304S Arthrodesis Nail, LEFT Ø13 x 540mm K395494 18291304S Arthrodesis Nail, LEFT Ø13 x 540mm K156526 18291304S Arthrodesis Nail, LEFT Ø13 x 540mm K210495 18291304S Arthrodesis Nail, LEFT Ø13 x 540mm K250369 18291304S Arthrodesis Nail, LEFT Ø13 x 540mm K129744 18291304S Arthrodesis Nail, LEFT Ø13 x 540mm K516239 18291304S Arthrodesis Nail, LEFT Ø13 x 540mm K800545 18291308S Arthrodesis Nail, LEFT Ø13 x 580mm K634948 18291308S Arthrodesis Nail, LEFT Ø13 x 580mm K793958 18291308S Arthrodesis Nail, LEFT Ø13 x 580mm K252647 18291308S Arthrodesis Nail, LEFT Ø13 x 580mm K189054 18291308S Arthrodesis Nail, LEFT Ø13 x 580mm K144182 18291308S Arthrodesis Nail, LEFT Ø13 x 580mm K125513 18291308S Arthrodesis Nail, LEFT Ø13 x 580mm K675653 18291308S Arthrodesis Nail, LEFT Ø13 x 580mm K857464 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K912208 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K395493 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K156527 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K140297 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K196993 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K250368 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K131411 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K571140 18291312S Arthrodesis Nail, LEFT Ø13 x 620mm K486579 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K168867 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K739423 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K285913 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K273150 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K153006 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K150826 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K144179 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K130898 18291316S Arthrodesis Nail, LEFT Ø13 x 660mm K941225 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K105555 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K291225 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K923684 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K739419 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K156548 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K252654 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K210491 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K172102 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K219680 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K185072 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K205385 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K133245 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K125510 18291320S Arthrodesis Nail, LEFT Ø13 x 700mm K857465 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K634950 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K739402 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K395495 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K890911 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K152098 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K271360 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K250367 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K219681 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K294123 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K259501 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K191811 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K159668 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K130899 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K858123 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K996615 18291324S Arthrodesis Nail, LEFT Ø13 x 740mm K971900 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K219682 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K174621 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K154903 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K154905 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K129034 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K822870 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K436720 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K552012 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K923681 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K579494 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K395496 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K669017 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K847903 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K125016 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K259581 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K243245 18291328S Arthrodesis Nail, LEFT Ø13 x 780mm K196994 18291354S Arthrodesis Nail, RIGHT Ø13 x 540mm K919062 18291354S Arthrodesis Nail, RIGHT Ø13 x 540mm K115012 18291354S Arthrodesis Nail, RIGHT Ø13 x 540mm K250366 18291354S Arthrodesis Nail, RIGHT Ø13 x 540mm K216821 18291354S Arthrodesis Nail, RIGHT Ø13 x 540mm K171316 18291354S Arthrodesis Nail, RIGHT Ø13 x 540mm K138297 18291354S Arthrodesis Nail, RIGHT Ø13 x 540mm K941224 18291358S Arthrodesis Nail, RIGHT Ø13 x 580mm K291250 18291358S Arthrodesis Nail, RIGHT Ø13 x 580mm K847916 18291358S Arthrodesis Nail, RIGHT Ø13 x 580mm K128683 18291358S Arthrodesis Nail, RIGHT Ø13 x 580mm K189317 18291358S Arthrodesis Nail, RIGHT Ø13 x 580mm K271359 18291358S Arthrodesis Nail, RIGHT Ø13 x 580mm K221116 18291358S Arthrodesis Nail, RIGHT Ø13 x 580mm K154902 18291362S Arthrodesis Nail, RIGHT Ø13 x 620mm K739401 18291362S Arthrodesis Nail, RIGHT Ø13 x 620mm K395497 18291362S Arthrodesis Nail, RIGHT Ø13 x 620mm K115013 18291362S Arthrodesis Nail, RIGHT Ø13 x 620mm K125017 18291362S Arthrodesis Nail, RIGHT Ø13 x 620mm K153004 18291362S Arthrodesis Nail, RIGHT Ø13 x 620mm K125514 18291362S Arthrodesis Nail, RIGHT Ø13 x 620mm K443306 18291362S Arthrodesis Nail, RIGHT Ø13 x 620mm K406131 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K579495 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K210490 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K144570 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K221117 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K171317 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K529708 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K946483 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K404269 18291366S Arthrodesis Nail, RIGHT Ø13 x 660mm K992981 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K928331 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K739400 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K152096 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K250360 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K273151 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K171318 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K137346 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K128493 18291370S Arthrodesis Nail, RIGHT Ø13 x 700mm K946729 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K390804 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K213835 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K890912 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K266892 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K210489 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K253420 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K219683 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K171320 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K174509 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K675584 18291374S Arthrodesis Nail, RIGHT Ø13 x 740mm K913150 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K389587 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K156617 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K126213 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K289453 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K229364 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K153857 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K144568 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K182395 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K138350 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K129745 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K699574 18291378S Arthrodesis Nail, RIGHT Ø13 x 780mm K834177 18292004S Arthrodesis Nail, LEFT Ø10 x 540mm K129746 18292004S Arthrodesis Nail, LEFT Ø10 x 540mm K965758 18292004S Arthrodesis Nail, LEFT Ø10 x 540mm K397975 18292004S Arthrodesis Nail, LEFT Ø10 x 540mm K579496 18292004S Arthrodesis Nail, LEFT Ø10 x 540mm K209125 18292004S Arthrodesis Nail, LEFT Ø10 x 540mm K145057 18292008S Arthrodesis Nail, LEFT Ø10 x 580mm K264254 18292008S Arthrodesis Nail, LEFT Ø10 x 580mm K160401 18292008S Arthrodesis Nail, LEFT Ø10 x 580mm K147168 18292008S Arthrodesis Nail, LEFT Ø10 x 580mm K129747 18292008S Arthrodesis Nail, LEFT Ø10 x 580mm K133232 18292008S Arthrodesis Nail, LEFT Ø10 x 580mm K106063 18292012S Arthrodesis Nail, LEFT Ø10 x 620mm K634952 18292012S Arthrodesis Nail, LEFT Ø10 x 620mm K579497 18292012S Arthrodesis Nail, LEFT Ø10 x 620mm K177757 18292012S Arthrodesis Nail, LEFT Ø10 x 620mm K153001 18292012S Arthrodesis Nail, LEFT Ø10 x 620mm K141826 18292012S Arthrodesis Nail, LEFT Ø10 x 620mm K491099 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K634953 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K890913 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K252669 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K119461 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K292168 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K154897 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K137366 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K129748 18292016S Arthrodesis Nail, LEFT Ø10 x 660mm K667684 18292020S Arthrodesis Nail, LEFT Ø10 x 700mm K634956 18292020S Arthrodesis Nail, LEFT Ø10 x 700mm K579498 18292020S Arthrodesis Nail, LEFT Ø10 x 700mm K285336 18292020S Arthrodesis Nail, LEFT Ø10 x 700mm K149932 18292020S Arthrodesis Nail, LEFT Ø10 x 700mm K259500 18292020S Arthrodesis Nail, LEFT Ø10 x 700mm K188418 18292020S Arthrodesis Nail, LEFT Ø10 x 700mm K133243 18292020S Arthrodesis Nail, LEFT Ø10 x 700mm K491120 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K862866 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K168869 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K560636 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K250355 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K157207 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K152999 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K133235 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K128495 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K521105 18292024S Arthrodesis Nail, LEFT Ø10 x 740mm K401749 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K923677 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K579500 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K115014 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K189316 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K189984 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K154893 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K133239 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K965755 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K491139 18292028S Arthrodesis Nail, LEFT Ø10 x 780mm K491122 18292054S Arthrodesis Nail, RIGHT Ø10 x 540mm K268178 18292054S Arthrodesis Nail, RIGHT Ø10 x 540mm K177765 18292054S Arthrodesis Nail, RIGHT Ø10 x 540mm K164343 18292054S Arthrodesis Nail, RIGHT Ø10 x 540mm K140921 18292054S Arthrodesis Nail, RIGHT Ø10 x 540mm K999260 18292058S Arthrodesis Nail, RIGHT Ø10 x 580mm K293137 18292058S Arthrodesis Nail, RIGHT Ø10 x 580mm K152996 18292058S Arthrodesis Nail, RIGHT Ø10 x 580mm K888605 18292058S Arthrodesis Nail, RIGHT Ø10 x 580mm K719553 18292058S Arthrodesis Nail, RIGHT Ø10 x 580mm K140295 18292058S Arthrodesis Nail, RIGHT Ø10 x 580mm K215572 18292062S Arthrodesis Nail, RIGHT Ø10 x 620mm K291229 18292062S Arthrodesis Nail, RIGHT Ø10 x 620mm K201189 18292062S Arthrodesis Nail, RIGHT Ø10 x 620mm K152995 18292062S Arthrodesis Nail, RIGHT Ø10 x 620mm K898086 18292066S Arthrodesis Nail, RIGHT Ø10 x 660mm K115015 18292066S Arthrodesis Nail, RIGHT Ø10 x 660mm K189315 18292066S Arthrodesis Nail, RIGHT Ø10 x 660mm K117497 18292066S Arthrodesis Nail, RIGHT Ø10 x 660mm K175470 18292066S Arthrodesis Nail, RIGHT Ø10 x 660mm K140785 18292066S Arthrodesis Nail, RIGHT Ø10 x 660mm K129749 18292066S Arthrodesis Nail, RIGHT Ø10 x 660mm K409066 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K153831 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K117498 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K190231 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K171319 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K154892 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K138301 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K102534 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K491147 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K881487 18292070S Arthrodesis Nail, RIGHT Ø10 x 700mm K491145 18292074S Arthrodesis Nail, RIGHT Ø10 x 740mm K719554 18292074S Arthrodesis Nail, RIGHT Ø10 x 740mm K634957 18292074S Arthrodesis Nail, RIGHT Ø10 x 740mm K556940 18292074S Arthrodesis Nail, RIGHT Ø10 x 740mm K210488 18292074S Arthrodesis Nail, RIGHT Ø10 x 740mm K177412 18292074S Arthrodesis Nail, RIGHT Ø10 x 740mm K154891 18292074S Arthrodesis Nail, RIGHT Ø10 x 740mm K140782 18292074S Arthrodesis Nail, RIGHT Ø10 x 740mm K491186 18292078S Arthrodesis Nail, RIGHT Ø10 x 780mm K284438 18292078S Arthrodesis Nail, RIGHT Ø10 x 780mm K113085 18292078S Arthrodesis Nail, RIGHT Ø10 x 780mm K115016 18292078S Arthrodesis Nail, RIGHT Ø10 x 780mm K285337 18292078S Arthrodesis Nail, RIGHT Ø10 x 780mm K177766 18292078S Arthrodesis Nail, RIGHT Ø10 x 780mm K152994 18292078S Arthrodesis Nail, RIGHT Ø10 x 780mm K947269 18292078S Arthrodesis Nail, RIGHT Ø10 x 780mm K767260 Class II Stryker has become aware that there exists a potential for breach of the sterile barrier of packaging associated with certain lots of T2 Knee Arthrodesis Nails. Stryker Howmedica Osteonics Corp.
Veterinary INJECTABLES: (No product labeling available) ACEPROMAZINE MALEATE 2MG/ML INJECTABLE 50 ML. ACEPROMAZINE MALEATE** 10 MG/ML INJECTABLE 50 ML. ACETYLCYSTEINE 10% INJECTABLE 100 ML. ACETYLCYSTEINE 20% INJECTABLE 30 ML, 50 ML, 90 ML, 100 ML, 120 ML, 120 ML, 180 ML, 200 ML, 300 ML, 400 ML, 600 ML. ACETYL-D-GLUCOSAMINE 10% INJECTABLE 10 ML, 20 ML, 25 ML, 60 ML, 90 ML, 100 ML, 300 ML, 400 ML, 500 ML, 600 ML, 1000 ML, 1200 ML, 1800 ML, 2000 ML, 2400 ML. ACETYL-D-GLUCOSAMINE 20% INJECTABLE 50 ML 100 ML 200 ML 300 ML 400 ML 600 ML 2000 ML. ACETYL-D-GLUCOSAMINE 25% INJECTABLE 50 ML 100 ML 400 ML 500 ML 1500 ML. ACTH GEL 10UNITS/ML INJECTABLE 2 ML. ACTH GEL 12.2UNITS/ML INJECTABLE 5 ML. ACTH GEL 20UNITS/ML INJECTABLE 3 ML, 5 ML, 10 ML. ACTH GEL 25UNITS/ML INJECTABLE 1 ML 3 ML 6 ML ACTH GEL 40UNITS/ML INJECTABLE 1 ML 2.5 ML 3 ML 4 ML 5 ML 10 ML 15 ML 40 ML. ACTH GEL 50UNITS/ML INJECTABLE 1.28 ML. ACTH GEL 80UNITS/ML INJECTABLE 1.2 ML 2 ML 5 ML 6 ML 10 ML 20 ML 30 ML 40 ML 100 ML. ADENOSINE MONOPHOSPHATE 200MG/ML INJECTABLE 30 ML 50 ML 100 ML 150 ML 180 MLS 250 ML 400 ML. ALTRENOGEST (DUO-RELEASE VEHICLE) 150 MG/ML INJECTABLE 10 ML 11 ML 25 ML 30 ML. AMIKACIN (VET) IM/IV 100MG/ML INJECTABLE 20 ML. AMIKACIN (VET) IM/IV 50MG/ML INJECTABLE 20 ML 50 ML. AMIKACIN P. F. 250MG/ML INJECTABLE 10 ML 12 ML. AMIKACIN SULFATE (VET) 250MG/ML INJECTABLE 2 ML 4 ML 6 ML 8 ML 10 ML 12 ML 16 ML 20 ML 24 ML 30 ML 32 ML 34 ML 36 ML 40 ML 42 ML 48 ML 50 ML 60 ML 80 ML 100 ML 120 ML 150 ML 160 ML. 200 ML 250 ML 300 ML 400 ML 2400 ML. AMIKACIN SULFATE**** 4ML SDV 250MG/ML INJECTABLE 40 ML 400 MLS. AMINO ACID WITH VIT. B12 INJECTABLE 100 ML. AMINOPENTAMIDE, P.F. 0.5MG/ML INJECTABLE 10 ML 20 ML 30 ML. AMINOSYN II** (12X500ML) 8.5% INJECTABLE 18000 ML. AMMONIUM CHLORIDE 2% INJECTABLE 200 ML. AMMONIUM SULFATE 0.75% INJECTABLE 100 ML 200 ML. AMMONIUM SULFATE 10% INJECTABLE 30 MLS 60 MLS 100 MLS 200 MLS 800 MLS. AMMONIUM SULFATE 5% INJECTABLE 100 ML. ANTICOAGULANT CITRATE DEXTROSE (NO CLOT) INJECTABLE 50 ML. APOMORPHINE 1MG/ML INJECTABLE 10 ML 30 ML 250 ML. APOMORPHINE 2MG/ML INJECTABLE 5 ML 10 ML 30 ML. APOMORPHINE 3MG/ML INJECTABLE 5 ML 10 ML 15 ML 30 ML. APOMORPHINE 4MG/ML INJECTABLE 10 ML. APOMORPHINE 5MG/ML INJECTABLE 5 ML 10 ML. APOMORPHINE 6MG/ML INJECTABLE 5 ML 10 ML. ARANESP (4X1ML SDV)** 25MCG/ML INJECTABLE 4 VIALS. ASCORBIC ACID 100MG/ML INJECTABLE 250 ML 750 ML 1500 ML. ASPIRIN 100MG/ML INJECTABLE 50 MLS. ATROPINE SULFATE 0.4MG/ML INJECTABLE 25 ML 40 ML 60 ML 200 ML. ATROPINE SULFATE 0.54MG/ML INJECTABLE 100 ML 200 ML. ATROPINE SULFATE***MDV 0.4MG/ML INJECTABLE 200 ML. AZI CMPND (PCN-G-PROCAINE/STREPTOMYCIN) 125,000U/245MG/ML INJECTABLE 100 ML. BETAMETHASONE ACETATE 6MG/ML INJECTABLE 300 ML. BETHANECHOL 5MG/ML INJECTABLE 60 ML 180 ML. BIMIX 30MG / 5MG INJECTABLE 20 ML. BIMIX 30MG/1MG INJECTABLE 5 ML. BUPIVACAINE HCL 0.25% INJECTABLE 5 ML. BUPRENEX AMPULES** 0.3MG/ML INJECTABLE 5 ML 10 ML. BUPRENORPHINE HCL MDV 0.4MG/ML INJECTABLE 10 ML 20 ML 50 ML. BUPRENORPHINE HCL 0.5MG/ML INJECTABLE 10 ML 20 ML 30 ML 50 ML. BUPRENORPHINE HCL 0.6MG/ML INJECTABLE 10 ML 20 ML 30 ML 60 ML 100 ML 200ML. BUPRENORPHINE HCL MDV 0.3MG/ML INJECTABLE 30 ML 60 ML. BUPRENORPHINE HCL P.F. 0.3MG/ML INJECTABLE 10 ML 30 ML. CACODYLATE COMPOUND (32MG/5ML) 6.4MG/1MG/0.2MG/ML INJECTABLE 100 ML 200 ML 300 ML 400 ML 500 ML 600 ML 1000 ML 1200 ML 3600 ML 4800 ML. CACODYLATE COMPOUND 100MG/ML INJECTABLE 200 ML. CACODYLATE COMPOUND 50MG/5ML (10MG/ML) INJECTABLE 100 ML 200 ML. CALCIUM EDTA 100MG/ML INJECTABLE 10 ML 100 ML. CALCIUM EDTA 10MG/ML INJECTABLE 100 ML. CALCIUM EDTA 200MG/ML INJECTABLE 5 ML 50 ML 60 ML 150 ML. CALCIUM EDTA 500MG/ML INJECTABLE 60 ML. CALCIUM GLUCONATE ***(50ML) 10% INJECTABLE 50 ML. CALCIUM GLYC/ CALCIUM LACTATE SOLUTION 50MG/50MG/10ML INJECTABLE 200 ML. CAMPHOR IN OLIVE OIL 10% INJECTABLE 500 ML. CAMPHORATED OIL (A) 10% INJECTABLE 100 ML 200 ML. CAMPHORATED OIL (S) 15% INJECTABLE 200 ML. CAMPHORATED OIL (S) 20% INJECTABLE 300 ML. CARBAZOCHROME/SODIUM SALICYLATE 2.5MG/105MG/ML INJECTABLE 100 ML 120 ML 200 ML 240 ML 400 ML 600 ML. CARBAZOCHROME/SODIUM SALICYLATE 5MG/125MG/ML INJECTABLE 100 ML. CARBOPLATIN**(10MG/ML) 15ML MDV 150MG/15ML INJECTABLE 30 ML. CARNITINE-L/PHENYLALANINE-D/ISOLEUCINE-L 200MG/4MG/5.33MG/ML INJECTABLE 200 ML 600 ML. CEFOTAXIME, 2GM SDV** 2 GRAM INJECTABLE 50 GM 100 GM. CELESTONE, 5ML MDV** 3MG/3MG/ML INJECTABLE 5 MLS. CHLORPROMAZINE HCL 100MG/ML INJECTABLE 50 ML 100 ML. CHLORPROMAZINE HCL 25MG/ML INJECTABLE 200 ML. CHLORPROMAZINE HCL 50MG/ML INJECTABLE 50 ML. CHONDROITIN/GLUCOSAMINE 1%/10% INJECTABLE 120 ML. CHONDROITIN/GLUCOSAMINE 10%/20% INJECTABLE 100 ML 300 ML. CHORIONIC GONADOTROPIN (HCG) 2,000 U/ML INJECTABLE 1 VIAL. CHORIONIC GONADOTROPIN, (HCG) 7,000 UNIT VIAL INJECTABLE 1 VIAL. CHORIONIC GONADOTROPIN, LYOPHILIZED (HCG) 5,000 UNIT VIAL INJECTABLE 2 VIAL. CHYMOTRYPSIN, ALPHA 5MG/ML (0.5%) INJECTABLE 5 ML 10 ML. CHYMOTRYPSIN, POWDER 22MG INJECTABLE 12 VIAL. CIMETIDINE 150MG/ML INJECTABLE 100 ML 200 ML. CISAPRIDE 5MG/ML INJECTABLE 100 ML. CISAPRIDE 4MG/ML INJECTABLE 200 ML. CISPLATIN POWDER 2MG INJECTABLE 3 VIAL. CISPLATIN POWDER 5MG INJECTABLE 1 VIAL. CISPLATIN POWDER 10MG INJECTABLE 1 VIAL 2 VIAL 3 VIAL 4 VIAL 5 VIAL 6 VIAL 8 VIAL. CISPLATIN POWDER 15MG INJECTABLE 1 VIAL 3 VIAL. CISPLATIN POWDER 20MG INJECTABLE 1 VIAL 2 VIAL. CISPLATIN POWDER 3.3MG INJECTABLE 1 VIAL. CISPLATIN POWDER 30MG INJECTABLE 1 VIAL. CISPLATIN POWDER 6MG INJECTABLE 1 VIAL. CISPLATIN POWDER 8MG INJECTABLE 1 VIAL. CLAFORAN VIAL** 2GM INJECTABLE 120 GMS. CYANOCOBALAMIN (VIT B12 ) 6,000MCG/ML INJECTABLE 100 ML 200 ML. DEPO-TESTOSTERONE, MDV, 10ML** 100MG/ML INJECTABLE 1 VIAL. DEPO-TESTOSTERONE, MDV, 10ML** 200MG/ML INJECTABLE 10 ML 30 MLS. DESLORELIN & HCG, LYOPHILIZED 15MG/20,000 UNITS VIAL 1 VIAL 2 VIAL 3 VIAL 4 VIAL 5 VIAL 6 VIAL 16 VIAL 20 ML 30 VIAL 40 VIAL. DESLORELIN (DUO-RELEASE VEHICLE) 1.5 MG/ML INJECTABLE 20 ML. DESLORELIN LOW DOSE 50 MCG/ML INJECTABLE 5 ML 25 ML 28 ML 50 ML 100 ML 210 ML. DESLORELIN/CHORIONIC GONADOTROPIN (VIAL) 1.5MG/2,000 IU/ML INJECTABLE 5 ML 10 ML 20 ML 30 ML 40 ML 50 ML 60 ML 70 ML 80 ML 90 ML 100 ML 200 ML. DESLORELIN/CHORIONIC GONADOTROPIN (VIAL) 1.5MG/5,000 IU/ML INJECTABLE 30 ML. DESOXYCORTICOSTERONE ACETATE 75MG/ML INJECTABLE 4 ML. DETOMIDINE HCL/XYLAZINE HCL 5MG/100MG/ML INJECTABLE 20 ML 40 ML. DEXAMETHASONE 21- ISONICOTINATE 1MG/ML INJECTABLE 100 ML 1800 ML. DEXAMETHASONE SODIUM PHOSPHATE (P.F.) 1MG/ML INJECTABLE 200 ML 800 ML 1000 ML. DEXAMETHASONE SODIUM PHOSPHATE 4MG/ML INJECTABLE 100 ML. DEXAMETHASONE SODIUM PHOSPHATE/CYSTEAMINE/VITAMIN C P.F. 1.15MG/37.5MG/125MG/ML 100 ML 800 ML 1000 ML. DEXPANTHENOL 250MG/ML INJECTABLE 30 ML 60 ML. DIAZEPAM (IM/IV) 5MG/ML INJECTABLE 10 ML 20 ML 30 ML 40 ML 50 ML 60 ML 80 ML 90 ML 100 ML 120 ML 200 ML 250 ML 300 ML 400 ML 450 ML 800 ML 1000 ML. DIAZEPAM 10MG/ML INJECTABLE 10 ML. DIPHENHYDRAMINE 50MG/ML INJECTABLE 50 ML. DIPHENHYDRAMINE PRESERVATIVE FREE 50MG/ML INJECTABLE 100 ML. DIPYRONE 250MG/ML INJECTABLE 50 ML. DIPYRONE 500MG/ML INJECTABLE 20 ML 30 ML 50 ML 60 ML 100 ML 200 ML 300 ML 600 ML 1200 ML. DIPYRONE 50MG/ML INJECTABLE 50 ML 500 ML 600 ML. DMSO 90% INJECTABLE 5760 ML. DOXORUBICIN HCL, LYOPHILIZED 10MG VIAL 1 VIAL 2 VIAL 10 VIAL. DOXORUBICIN HCL, LYOPHILIZED 50MG VIAL 1 VIAL 2 VIALS 5 VIAL. DOXYCYCLINE HCL --- (FOR I.M./S.C USE ONLY) 100MG/ML INJECTABLE 5 ML 8 ML 10 ML. DOXYCYCLINE HCL (I.M./S.C.) 25MG/ML INJECTABLE 10 ML. DOXYCYCLINE HCL (I.M./S.C.) 50MG/ML INJECTABLE 30 ML. DOXYCYCLINE, I.V. 100MG/ML INJECTABLE 10 ML. EDTA CALCIUM DISODIUM (PRESERVATIVE FREE) 150MG/ML INJECTABLE 200 ML 300 ML. EDTA CALCIUM DISODIUM 50MG/ML INJECTABLE 15 ML. ELECTROLYTE SOLUTION INJECTABLE 100 ML 200 ML 400 ML. ELECTROLYTE SOLUTION DS DS INJECTABLE 100 ML. ENROFLOXACIN 50MG/ML INJECTABLE 50 ML 300 ML. EPHEDRINE SULFATE PF 1MG/ML INJECTABLE 5 ML 30 ML. EPOGEN, 1ML VIAL** 2,000/ML INJECTABLE 1 VIAL 2 VIAL 6 VIAL. ERYTHROCIN LACTOBIONATE*** 500MG INJECTABLE 10 VIAL. ESTRADIOL 17B 3.33MG/ML INJECTABLE 50 ML. ESTRADIOL AQUEOUS 10MG/ML INJECTABLE 30 ML. ESTRADIOL BENZOATE 10 MG/ML INJECTABLE 20 ML. ESTRADIOL BENZOATE 20 MG/ML INJECTABLE 10 ML. ESTRADIOL CYPIONATE 10MG/ML INJECTABLE 200 ML. ESTRADIOL CYPIONATE 1MG/ML INJECTABLE 5 ML 10 ML. ESTRADIOL CYPIONATE 2MG/ML INJECTABLE 5 ML 20 ML 30 ML 50 ML 60 ML 100 ML 150 ML 250 ML 300 ML. ESTRADIOL CYPIONATE 4MG/ML INJECTABLE 90 ML 100 ML 200 ML. ESTRADIOL CYPIONATE 5MG/ML INJECTABLE 10 ML 20 ML 30 ML 40 ML 50 ML 60 ML 80 ML 90 ML 100 ML 120 ML 140 ML 150 ML 200 ML. ESTRONE AQUEOUS 10MG/ML INJECTABLE 30 ML 50 ML 60 ML 90 ML 100 ML 150 ML 200 ML 300 ML. ESTRONE AQUEOUS 5MG/ML INJECTABLE 20 ML 30 ML 50 ML 60 ML 90 ML 100 ML 120 ML 150 ML 180 ML 200 ML 240 ML 300 ML 360 ML 400 ML 500 ML 600 ML 700 ML 4800 ML. ESTRONE SULFATE PIPERAZINE 5MG/ML INJECTABLE 50 ML 100 ML. ETHYL ALCOHOL 70% INJECTABLE 10 ML 30 ML 60 ML. ETHYL ALCOHOL 95% INJECTABLE 100 ML. FAMOTIDINE *** MDV 40MG/4ML INJECTABLE 20 ML. FAMOTIDINE ***SDV 10MG/ML INJECTABLE 200 ML. FENTANYL /DROPERIDOL 0.4MG/20MG/ML INJECTABLE 10 ML. FLUCONAZOLE IN NORMAL SALINE** 2MG/ML (0.2GM/100ML) INJECTABLE 200 ML. FLUMETHASONE PIVALATE 0.05% (0.5MG/ML) INJECTABLE 100 ML 2400 ML 4800 ML. FLUNIXIN MEGLUMINE 50MG/ML INJECTABLE 100 ML. FLUOROURACIL 3% INJECTABLE 20 ML. FLUOROURACIL P.F. 5% INJECTABLE 50 ML 70 ML. FLUOROURACIL, P.F. 1% INJECTABLE 5 ML 30 ML 100 ML. FLUOROURACIL, SDV, (10X10ML) VIAL** 50MG/ML INJECTABLE 30 ML. FLUOROURACIL, SDV, 50 ML VIAL** 50MG/ML (2.5GM/50ML) INJECTABLE 100 ML. FLUPHENAZINE DECANOATE 100MG/ML INJECTABLE 40 ML. FLUPHENAZINE DECANOATE 25MG/ML INJECTABLE 5 ML 10 ML 20 ML 200 ML. FLUPHENAZINE DECANOATE 50MG/ML INJECTABLE 5 ML 10 ML 20 ML. FLUPHENAZINE DECANOATE, 5ML VIAL** 25mg/ml INJECTABLE 5 ML 10 ML 15 ML 20 ML 25 ML 30 ML. FOLIC ACID 50MG/ML INJECTABLE 100 ML. GENTAMICIN*** (250ML) 100MG/ML INJECTABLE 250 ML. GENTAMICIN***(80MGX2ML) 40MG/ML INJECTABLE 20 MLS 50 ML. GLUCOSAMINE SULFATE 20% INJECTABLE 100 ML. GLUTATHIONE P.F. 100MG/ML INJECTABLE 60 ML. GLUTATHIONE-FFC 100MG/ML INJECTABLE 30 ML. GLYCOPYRROLATE 0.2MG/ML INJECTABLE 20 ML. GLYCOPYRROLATE, 20ML VIALS** 0.2MG/ML INJECTABLE 200 ML. GTQ W/O DEX (EQUINE USE ONLY) INJECTABLE 1000 ML 1500 ML 2500 ML 3000 ML 5000 ML. GUAIFENESIN SOLUTION 5% (50MG/ML) INJECTABLE 1000 ML 1500 ML 2000 ML 3000 ML 4000 ML 5000 ML 6000 ML 7000 ML 8000 ML 10000 ML 14000 ML 24000 ML. GUANABENZ ACETATE 2% (20MG/ML) INJECTABLE 5 ML 30 ML 90 ML. GUANABENZ ACETATE 2MG/ML INJECTABLE 20 ML 30 ML 100 ML. GUANABENZ ACETATE 4MG/ML INJECTABLE 10 ML 30 ML 100 ML 600 ML. GUANABENZ ACETATE 8MG/ML INJECTABLE 60 ML. HEMO COMP. 15 INJECTABLE 100 ML 200 ML 300 ML 400 ML. HEPARIN SODIUM**(25X1ML) 10,000U/ML INJECTABLE 25 ML. HEPARIN SODIUM**(25X2ML) P.F.(PURPLE CAPS) 1,000U/ML(1MU/ML INJECTABLE 50 ML. HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 30 ML 50 ML 100 MLS. HYALURONIC ACID SODIUM SALT / AMIKACIN 10MG/25MG/ML INJECTABLE 40 ML 60 ML 80 ML. HYALURONIC ACID SODIUM SALT, P.F. 10MG/ML INJECTABLE 6 ML. HYALURONIC ACID/CHONDROITIN/GLUCOSAMINE 0.5%/10%/10% INJECTABLE 10 ML 20 ML 40 ML 60 ML 120 ML. HYALURONIC ACID/CHONDROITIN/GLUCOSAMINE 0.5%/10%/20% INJECTABLE 60 ML. HYALURONIDASE - PRESERVATIVE FREE 200 U/ML INJECTABLE 20 MLS. HYALURONIDASE 150 U/ML INJECTABLE 5 MLS 10 MLS 20 MLS. HYDROCORTISONE ACETATE 25MG/ML INJECTABLE 100 ML. HYDROMORPHONE P.F. 2MG/ML INJECTABLE 60 ML. HYDROXYPROGESTERONE CAPROATE 200MG/ML INJECTABLE 10 ML. HYDROXYPROGESTERONE CAPROATE 250MG/ML INJECTABLE 10 ML 15 ML 20 ML 25 ML 30 ML 60 ML. INJECTION VEHICLE INJECTABLE 1 ML 2 ML 3 ML 4 ML 5 ML 6 ML 8 ML 10 ML 15 ML 20 ML 30 ML. INSULIN NPH, LO-DOSE 5U/ML (0.5U/0.1ML) INJECTABLE 20 ML. INTERFERON ALPHA-2B 60IU/ML INJECTABLE 10 ML. IODINE (A) /ETHER 1.9%/0.9% INJECTABLE 100 ML 200 ML 300 ML. IODINE (P) /ETHER 1.9%/0.9% INJECTABLE 200 ML 300 CC, ML, MLS 400 ML, MLS 500 ML 600 ML. IODINE (P) /ETHER 3%/0.9% INJECTABLE 1200 ML. IODINE IN ALMOND OIL 1% INJECTABLE 100 ML. IODINE IN ALMOND OIL 2% INJECTABLE 20 ML 30 ML 50 ML 60 ML 80 ML 90 ML 100 ML 200 ML 300 ML 400 ML 500 ML , MLS 600 ML 800 ML 900 ML 1000 ML 1200 ML 1800 ML 2400 ML. IODINE IN ALMOND OIL 3% INJECTABLE 100 ML, MLS 200 ML 300 ML 400 ML 600 ML 800 ML. IODINE IN SESAME OIL 2% INJECTABLE 200 ML. IRON / VITAMIN B INJECTABLE 100 ML. IRON SUCROSE - FOR IV USE ONLY 20MG/ML (ELEMENTAL IRON) INJECTABLE 100 ML 150 ML 200 ML. ISOFLUPREDONE ACETATE (FROM PREDEF 2X) 2MG/ML INJECTABLE 600 ML 800 ML. ISOMETHEPTENE 100MG/ML INJECTABLE 5 ML. IVERMECTIN 0.005MG/0.1ML INJECTABLE 0.2 ML. KETAMINE HCL 200MG/ML INJECTABLE 1 ML 2 ML 3 ML. KETOPROFEN (WITHOUT ARGININE) 10% INJECTABLE 50 ML 100 ML 400 ML. KETOPROFEN 10% INJECTABLE 100 ML 1200 ML. KETOPROFEN/MSM 10%1% (100MG/10MG/ML) INJECTABLE 4800 ML. LEUCOVORIN, LYOPHILIZED 100 MG VIAL INJECTABLE 1 VIAL 6 VIAL 16 VIAL. LEUCOVORIN, LYOPHILIZED 500 MG VIAL INJECTABLE 2 VIAL 3 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 100 MCG VIAL 1 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 1000 MCG (1MG) VIAL 1 VIAL 2 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 200 MCG VIAL 1 VIAL 2 VIAL 3 VIAL, VIALS 4 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 2000 MCG (2MG) VIAL 1 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 300 MCG VIA 1 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 400 MCG VIAL 1 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 500 MCG VIAL 1 VIAL 3 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 600 MCG VIAL 1 VIAL. LEUPROLIDE (MADE FROM LUPRON DEPOT 1 MONTH) 60MCG VIAL 2 VIAL. LEUPROLIDE ACETATE 100MCG/ML (0.1MG/ML) INJECTABLE 1 ML. LEUPROLIDE ACETATE 200MCG/ML (0.2MG/ML) INJECTABLE 2 ML 10 ML. LEUPROLIDE ACETATE 500MCG/ML (0.5MG/ML) INJECTABLE 1 ML. LEUPROLIDE ACETATE 60MCG/ML (0.06MG/ML) INJECTABLE 2 VIAL. LEVAMISOLE PHOSPHATE 136.5MG/ML INJECTABLE 500 ML 1000 ML 5000 ML 5500 ML. LIDOCAINE HCL 1% INJECTABLE 100 ML. LIDOCAINE HCL, AQUEOUS 2% INJECTABLE 250 ML. L-ISOLEUCINE/D-PHENYLALAMINE/L-ARGININE/L-TRYPTOPHAN/GABA 10MG/7.5MG/10MG/10MG/1 200 ML 600 ML 800 ML 1000 ML. L-ISOLEUCINE/D-PHENYLALANINE/L-ARGININE/L-TRYPTOPHAN/GABA 10MG/7.5MG/10MG/10MG/1 200 ML. LIVER / VITAMIN B COMPLEX B1, B2, B3, B5, B6, B12 INJECTABLE 100 ML. L-LYSINE, L-ARGININE 100MG/100MG/ML INJECTABLE 200 ML. L-TRYPTOPHAN 10MG/ML INJECTABLE 100ML 200 ML. L-TRYPTOPHAN - PRESERVATIVE FREE 100MG/ML INJECTABLE 1400 ML. MAGNESIUM CHLORIDE, PRESERVATIVE FREE 20% INJECTABLE 100 ML 250 ML. MAGNESIUM SULFATE, P.F. 50% (500MG/ML) INJECTABLE 100 ML 150 ML 200 ML 250 ML 300 ML 400 ML 450 ML 500 ML 600 ML 800 ML 1000 ML 1200 ML 1500 ML 2000 ML 2250 ML 2500 ML 3000 ML. MANNITOL 20% INJECTABLE 4000 ML 6500ML 14000 ML. MEDROXYPROGESTERONE ACETATE 100MG/ML INJECTABLE 3 MLS 10 MLS 15 ML 30 ML, MLS 40 MLS 50 MLS 60 MLS 80 MLS 90 MLS 100 MLS 120 ML, MLS 150 MLS 200 MLS. MEDROXYPROGESTERONE ACETATE 200MG/ML INJECTABLE 2.5 ML 3 ML 5 ML 8 ML 10 ML 12 MLS 15 ML, MLS 20 ML 25 ML 30 ML, MLS 50 ML, MLS 60 ML 90 ML 100 ML 120 ML 150 ML 180 ML, MLS 200 ML 240 ML, MLS 300 ML 360 ML 480 ML 720 ML 750 ML. MEDROXYPROGESTERONE ACETATE 250MG/ML INJECTABLE 5 MLS 10 ML 15 ML, MLS 16 MLS 20 ML, MLS 30 MLS 70 ML, MLS. MEPHENTERMINE 30MG/ML INJECTABLE 100 ML. MEPHENTERMINE 50MG/ML INJECTABLE 150 ML. METHOCARBAMOL 100MG/ML INJECTABLE 10 ML 20 ML 30 ML 100 ML, MLS 150 ML 200 ML 300 ML 400 ML 500 ML 600 ML 700 ML 800 ML 1000 ML 1200 ML 2000 ML 3600 ML. METHOCARBAMOL 200MG/ML INJECTABLE 100 ML. METHYLPREDNISOLONE ACETATE 100MG/ML INJECTABLE 50 ML. METHYLPREDNISOLONE ACETATE 40MG/ML INJECTABLE 30 ML 60 ML 100 ML 200 ML 300 ML 400 ML. METOCLOPRAMIDE HCL 10MG/ML INJECTABLE 30 ML 200 ML METOCLOPRAMIDE HCL 5MG/ML (10MG/2ML) INJECTABLE 10 ML 20 ML 25 ML 30 ML. METRONIDAZOLE (VET) 100MG/ML INJECTABLE 300 ML 1000 ML 1700 ML 2000 ML. METRONIDAZOLE 0.5% I.V. (5MG/ML) INJECTABLE 100 ML. MITOMYCIN 0.4MG/ML INJECTABLE 30 ML. MITOMYCIN, LYOPHILIZED (BUFFERED) 40MG INJECTABLE 8 VIAL. NANDROLONE DECANOATE 50MG/ML INJECTABLE 2 ML. NANDROLONE DECANOATE 30MG/ML INJECTABLE 5 ML. NANDROLONE DECANOATE- VET ONLY 100MG/ML INJECTABLE 4 ML 8 ML 15 ML 16 ML 20 ML. NANDROLONE DECANOATE, VET USE ONLY 200MG/ML INJECTABLE 2 ML 3 ML 10 ML 12 ML 30 ML. NEOSTIGMINE MS, 10ML MDV** 1:2000 INJECTABLE 100 ML. OMEPRAZOLE SODIUM 250MG/ML INJECTABLE 9 ML. OMEPRAZOLE SODIUM, PREMIX SOLUTION FOR F.D. 250MG/ML INJECTABLE 9 ML. OMEPRAZOLE, LYOPHILIZED (FOR KIT USE ONLY) 1.5GM INJECTABLE 1 VIAL. OMEPRAZOLE, LYOPHILIZED 1.5GM KIT 1 KIT, VIAL 2 KIT 6 KIT. OMEPRAZOLE, LYOPHILIZED 2.5GM KIT 3 KIT. OMEPRAZOLE, LYOPHILIZED 750MG KIT 2 KIT, VIAL 4 KIT 15 VIAL 35 VIAL. OMNIPAQUE, 50ML** 300MG/ML INJECTABLE 500 ML. OXALIC ACID 5% INJECTABLE 100 ML 4700 ML 4800 ML. OXALIC ACID/MALONIC ACID 5%/5% INJECTABLE 200 ML 300 ML. PENICILLIN-G-PROCAINE/STREPTOMYCIN 200,000U/160MG/ML INJECTABLE 5 ML 20 ML 30 ML 50 ML 100 ML 300 ML. PENTOSAN POLYSULFATE SODIUM/GLUCOSAMINE SULFATE 125MG/200MG/ML INJECTABLE 50 ML 100 ML. PENTOSAN POLYSULFATE/HYALURONIC ACID/GLUCOSAMINE 75MG/3MG/120MG/ML INJECTABLE 100 ML 200 ML 400 ML 600 ML. PENTOSAN SODIUM POLYSULFATE 100MG/ML INJECTABLE 48 ML. PENTOSAN SODIUM POLYSULFATE 250MG/ML INJECTABLE 6 ML 15 ML 20 ML, MLS 24 ML 25 ML 30 ML 40 ML 50 ML 60 ML 72 MLS 96 MLS 100 ML, MLS 150 ML 200 ML 250 ML 300 ML 500 ML 550 ML 600 ML. PENTOXIFYLLINE 50MG/ML INJECTABLE 100 ML. PFIZERPEN VIAL** 20MU INJECTABLE 25 VIAL. PHENOBARBITAL 130MG/ML INJECTABLE 100 ML. PHENOBARBITAL 30MG/ML INJECTABLE 10 ML. PHENOBARBITAL 65MG/ML INJECTABLE 5 ML 30 ML. PILOCARPINE HCL 2% INJECTABLE 100 ML. POLYETHYLENE GLYCOL (3350) SOLUTION 30% INJECTABLE 50 ML 100 ML. PRAZIQUANTEL 56 MG/ML INJECTABLE 30 ML 50 ML 100 ML. PRAZIQUANTEL 56.8 MG/ML INJECTABLE 50 ML. PRAZIQUANTEL 62.5 MG/ML INJECTABLE 50 ML. PREDNISOLONE ACETATE 10MG/ML INJECTABLE 50 MLS 100 MLS. PREDNISOLONE ACETATE 20MG/ML INJECTABLE 40 MLS 50 MLS. PREDNISOLONE ACETATE 25MG/ML INJECTABLE 10 MLS 20 MLS 30 MLS 100 MLS 300 MLS. PREDNISOLONE ACETATE 40MG/ML INJECTABLE 20 ML 30 MLS. PREDNISOLONE ACETATE 50MG/ML INJECTABLE 10 MLS 30 MLS 50 MLS 100 MLS. PREDNISONE 20MG/ML INJECTABLE 15 MLS. PREDNISONE 10MG/ML INJECTABLE 20 MLS 25 MLS 50 MLS 100 MLS. PREDNISONE 25MG/ML INJECTABLE 50 ML 100 ML. PREDNISONE 40MG/ML INJECTABLE 15 ML 20 ML 50 ML 100 ML. PREDNISONE 50MG/ML INJECTABLE 20 ML 100 ML. PRIMAXIN I.V.*** 500MG INJECTABLE 2 VIALS 6 VIALS 25 VIAL. PROCAINE HCL, P.F. 1% INJECTABLE 500 ML 750 ML PROCAINE HCL, P.F. 2% INJECTABLE 50 ML 100 ML 200 ML 300 ML 500 ML. PROCRIT, 1ML VIAL** 2,000 U/ML INJECTABLE 1 ML 2 ML, VIAL, VIALS 3 ML, VIAL 4 VIALS 6 ML, VIALS. PROGEST/ESTRADIOL-17B, SESAME OIL 50MG/3.33MG/ML INJECTABLE 100 ML 200 ML 400 ML. PROGESTERONE IN PEANUT OIL 150MG/ML INJECTABLE 100 ML. PROGESTERONE IN PROPYLENE GLYCOL/E2/SESAME OIL 150MG/5MG/ML INJECTABLE 100 ML 200 ML 400 ML 500 ML. PROGESTERONE IN PROPYLENE GLYCOL/SESAME OIL 100MG/ML INJECTABLE 100ML 200 ML 300 ML 400 ML. PROGESTERONE IN PROPYLENE GLYCOL/SESAME OIL 150MG/ML INJECTABLE 200 ML 400 ML. PROGESTERONE IN SESAME OIL 100MG/ML INJECTABLE 50 ML 100 ML 200 ML. PROGESTERONE IN SESAME OIL 150MG/ML INJECTABLE 30 ML 50 ML 60 ML 100 ML 150 ML 200 ML 300 ML 400 ML 500 ML 600 ML 1000 ML 1500 ML 1600 ML 2000 ML 3000 ML 3600 ML 5000 ML. PROGESTERONE IN SESAME OIL 50MG/ML INJECTABLE 50 ML 100 ML 300 ML 400 ML. PROGESTERONE/ESTRADIOL 150MG/5MG INJECTABLE 300 ML. PROPANTHELINE BROMIDE 50MG/ML INJECTABLE 30 ML. PROPYLENE GLYCOL 100% INJECTABLE 300 ML 500 ML. PYRIDOXINE 100MG/ML INJECTABLE 50 ML 60 ML. PYRILAMINE MALEATE 20MG/ML INJECTABLE 50 ML 100 ML 200 ML 300 ML 400 ML 1000 ML 1200 ML. PZI 10 IU/ML INJECTABLE 10 ML. PZI 100IU/ ML INJECTABLE 10 ML 20 ML 50 ML. PZI 40IU/ ML INJECTABLE 10 ML 15 ML 20 ML 30 ML 40 ML 50 ML 60 ML 100 ML. RANITIDINE 25MG/ML INJECTABLE 100 ML 400 ML 600 ML. RESERPINE 0.25MG/ML INJECTABLE 30 ML 40 ML 60 ML 120 ML 150 ML 180 ML 210 ML 240 ML 450 ML. RESERPINE 1.5MG/ML INJECTABLE 10 ML. RESERPINE 1MG/ML INJECTABLE 30 ML. RESERPINE 2.5MG/ML INJECTABLE 5 ML 10 ML 15 ML 20 ML 30 ML, MLS 40 ML 50 ML 60 ML 80 ML 100 ML 120 ML 150 ML 180 ML. RIFAMPIN FOR INJECTION, USP, VIAL** 600MG INJECTABLE 2 VIAL 3 VIAL, VIALS 4 VIAL. ROBINUL, 20ML VIAL** 0.2MG/ML INJECTABLE 200 ML. SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG VIAL 3 VIAL. SESAME OIL, STERILE INJECTABLE 1 ML 6 ML 8 ML 10 ML 12 ML 20 ML 30 ML 40 ML 50 ML 60 ML 80 ML. SODIUM BICARBONATE 5% INJECTABLE 750 ML 1500 ML. SODIUM BICARBONATE 8.4% INJECTABLE 100 ML. SODIUM BICARBONATE, MDV 8.4% INJECTABLE 200 ML. SODIUM CHLORIDE 0.9% BACTERIOSTATIC ** 0.9% INJECTABLE 20 ML 750 MLS. SODIUM IODIDE SOLUTION** 20% INJECTABLE 250 ML 500 ML 750 ML 1250 ML. SODIUM SALICYLATE 100MG/ML INJECTABLE 100 ML 200 ML. SODIUM SALICYLATE 200MG/ML INJECTABLE 600 ML. STANOZOLOL 50MG/ML INJECTABLE 30 ML. SULFADIAZINE/TRIMETHOPRIM 400MG/80MG/ML (48%) INJECTABLE 100 ML 150 ML 200 ML 300 ML 900 ML 1200 ML. SULPIRIDE IN SESAME OIL 200MG/ML INJECTABLE 25 ML. TAURINE 100MG/ML INJECTABLE 60 ML 90 ML 120 ML. TERBUTALINE SULFATE 10mg/ml INJECTABLE 60 MLS. TESTOSTERONE CYPIONATE (FROM RETAIL PRODUCT) 100MG/ML INJECTABLE 1 ML 10 ML. TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE 10 ML. TESTOSTERONE CYPIONATE IN SESAME OIL 200MG/ML INJECTABLE 5 ML. TESTOSTERONE, AQUEOUS 100MG/ML INJECTABLE 5 ML 6 ML 8 ML 10 ML 20 ML 30 ML. THERACYS, (BCG VACCINE) LIVE W/DILUENT** 81MG INJECTABLE 1 (blank). THIAMINE HCL 100MG/ML INJECTABLE 100 ML. TIMENTIN, VIAL** 3.1GM INJECTABLE 1 VIAL 10 VIAL. TOLAZOLINE HCL 10% INJECTABLE 100 ML 600 ML. TRANEXAMIC ACID 100MG/ML INJECTABLE 100 ML 200 ML 600 ML 800 ML. TRIAMCINOLONE ACETONIDE 10MG/ML INJECTABLE 600 ML 1200 ML. TRIAMCINOLONE ACETONIDE 2.5MG/ML INJECTABLE 20 ML. TRIAMCINOLONE ACETONIDE 2MG/ML INJECTABLE 40 ML 100 ML 200 ML 300 ML. TRIAMCINOLONE ACETONIDE 6MG/ML INJECTABLE 100 ML. TRIAMCINOLONE DIACETATE 40MG/ML INJECTABLE 15 ML 25 ML 30 ML. TRICHLORMETHIAZIDE/DEXAMETHASONE 10MG/0.5MG/ML INJECTABLE 200 ML 300 ML. TRIMIX 30MG / 1MG / 15MCG INJECTABLE 10 ML. TRIMIX 30MG / 1MG / 10MCG INJECTABLE 5 ML 10 ML. TRIPELENNAMINE HCL INJECTION 20 MG/ML INJECTABLE 90 ML 100 ML 180 ML 200 ML 250 ML 300 ML 400 ML 500 ML 550 ML 600 ML 1000 ML 3600 ML. ULTRA-TEST 100 (CYP 80%/ PROP 20%) 100MG/ML INJECTABLE 5 ML 20 ML 25 ML 30 ML. ULTRA-TEST 200 (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 10 ML 30 ML. ULTRA-TEST 200 IN SESAME OIL (CYP 80%/PROP 20%) 200MG/ML INJECTABLE 20 ML. VINBLASTINE 1MG/ML INJECTABLE 5 ML 10 ML 40 MLS. VINCRISTINE SULFATE, 1ML SDV, P.F.**(REFRIGERATE) 1MG/ML INJECTABLE 1 VIAL.VITAMIN A, D3, & E 100,000/10,000/20IU/ML INJECTABLE 10 ML 20 ML 30 ML 60 ML 100 ML 300 ML. VITAMIN A, D3, & E 33,333/3,333/6.33IU/ML INJECTABLE 5 ML 10 ML. VITAMIN A, D3, & E WITH B COMPLEX INJECTABLE 100 ML. VITAMIN AMINO ACID INJECTABLE 500 ML 600 ML. VITAMIN AMINO ACID, W/O IRON INJECTABLE 600 ML 1200 ML. VITAMIN B COMPLEX (B1,B2,B3,B5,B6,B12) 12.5/2/12.5/5/5MG/5MCG/ML INJECTABLE 100 ML. VITAMIN B COMPLEX (B1,B6,B12) 100MG/100MG/1000MCG/ML INJECTABLE 100 ML 200 ML. WATER BACT STERILE - (25X30ML)*** INJECTABLE 4 VIAL 30 ML 60 ML (blank) 90 ML 120 ML 180 ML. WATER STERILE - USP (25X10ML)* INJECTABLE 10 ML (blank) 40 ML 50 ML 160 (blank). WATER STERILE - USP (25X20ML)** INJECTABLE 20 ML. WATER STERILE - USP (25X50ML)** INJECTABLE 150 (blank). WESTERN W/O STRICHNINE 25MG/1MG/ML INJECTABLE 300 ML 500 ML. XYLAZINE HCL PRESERVATIVE FREE 100MG/ML INJECTABLE 100 ML. XYLAZINE HCL PRESERVATIVE FREE 200MG/ML INJECTABLE 30 ML. XYLAZINE HCL PRESERVATIVE FREE 300MG/ML INJECTABLE 20 ML 40 ML 50 ML 100 ML 200 ML. YOHIMBINE HCL - VET 5MG/ML (0.5%) INJECTABLE 100 ML 200 ML 300 ML 500 ML 600 ML 800 ML 1000 ML 3000 ML. Rx Numbers: 0321930, 0348432, 0349124, 0349236, 0349403, 0349678, 0350142, 0350284, 0350469, 0350940, 0351072, 0351523, 0351964, 0352014, 0352066, 0352181, 0352329, 0352444, 0352676, 0352683, 0352814, 0352861, 0352870, 0352871, 0352872, 0352873, 0353003, 0353058, 0353273, 0353368, 0353408, 0353479,0353551, 0353601, 0353617, 0353695, 0353800, 0353808, 0353895, 0353897, 0353940, 0354276, 0354474, 0354662, 0355167, 0355288, 0355450, 0355477, 0355540, 0355577, 0355580, 0355640, 0355656, 0355672, 0355747, 0355848, 0355990, 0356090, 0356312, 0356345, 0356390, 0356418, 0356453, 0356526, 0356680, 0356729, 0356901, 0357010, 0357192, 0357203, 0357404, 0357418, 0357728, 0357846, 0358013, 0358014, 0358109, 0358181, 0358668, 0358670, 0358848, 0358903, 0358916, 0359073, 0359086, 0359094, 0359307, 0359369, 0359370, 0359372, 0359375, 0359383, 0359469, 0359540, 0359549, 0359661, 0359662, 0359667, 0359683, 0359830, 0360031, 0360032, 0360035, 0360075, 0360088, 0360100, 0360186, 0360240, 0360275, 0360408, 0360550, 0360954, 0360956, 0361184, 0361298, 0361326, 0361328, 0361330, 0361362, 0361375, 0361425, 0361556, 0361559, 0361681, 0361720, 0361744, 0361848, 0361877, 0361897, 0362049, 0362084, 0362086, 0362101, 0362171, 0362246, 0362299, 0362301, 0362444, 0362454, 0362456, 0362546, 0362550, 0362561, 0362604, 0362633, 0362634, 0362705, 0362712, 0362741, 0362752, 0362820, 0362874, 0362895, 0363006, 0363033, 0363144, 0363156, 0363271, 0363345, 0363402, 0363538, 0363645, 0363647, 0363751, 0363803, 0363910, 0363959, 0363968, 0363986, 0363991, 0364048, 0364086, 0364121, 0364199, 0364321, 0364353, 0364358, 0364369, 0364371, 0364505, 0364639, 0364737, 0364745, 0364815, 0364837, 0364882, 0364997, 0365055, 0365110, 0365273, 0365280, 0365295, 0365361, 0365496, 0365497, 0365534, 0365561, 0365597, 0365606, 0365699, 0365739, 0365856, 0365859, 0365995, 0366049, 0366050, 0366064, 0366066, 0366078, 0366143, 0366191, 0366200, 0366229, 0366230, 0366240, 0366252, 0366350, 0366378, 0366396, 0366566, 0366653, 0366704, 0366786, 0366825, 0366843, 0366852, 0367101, 0367120, 0367161, 0367178, 0367216, 0367380, 0367461, 0367504, 0367616, 0367618, 0367650, 0367665, 0367710, 0367711, 0367731, 0367773, 0367803, 0368048, 0368126, 0368187, 0368232, 0368287, 0368291, 0368380, 0368383, 0368402, 0368427, 0368549, 0368789, 0368810, 0368837, 0368978, 0368980, 0368994, 0369074, 0369106, 0369158, 0369356, 0369478, 0369494, 0369537, 0369547, 0369622, 0370031, 0370034, 0370097, 0370134, 0370150, 0370162, 0370217, 0370227, 0370272, 0370346, 0370396, 0370421, 0370458, 0370535, 0370544, 0370567, 0370587, 0370592, 0370703, 0370753, 0370777, 0370796, 0370875, 0371037, 0371080, 0371088, 0371120, 0371321, 0371358, 0371360, 0371395, 0371396, 0371421, 0371426, 0371459, 0371565, 0371580, 0371631, 0371751, 0371787, 0371946, 0371999, 0372098, 0372128, 0372190, 0372286, 0372286, 0372317, 0372320, 0372531, 0372559, 0372567, 0372571, 0372575, 0372580, 0372620, 0372697, 0372712, 0372738, 0372924, 0372976, 0372996, 0373006, 0373121, 0373142, 0373199, 0373326, 0373378, 0373594, 0373622, 0373645, 0373751, 0373758, 0373759, 0373856, 0373873, 0373908, 0374052, 0374063, 0374188, 0374398, 0374404, 0374421, 0374422, 0374423, 0374424, 0374534, 0374630, 0374637, 0374671, 0374746, 0374750, 0374805, 0374989, 0375003, 0375032, 0375120, 0375207, 0375213, 0375449, 0375494, 0375573, 0375684, 0375694, 0375733, 0375741, 0375747, 0375751, 0375801, 0375974, 0376003, 0376027, 0376041, 0376071, 0376131, 0376333, 0376414, 0376423, 0376425, 0376492, 0376512, 0376543, 0376731, 0376789, 0377008, 0377050, 0377121, 0377205, 0377266, 0377317, 0377352, 0377499, 0377628, 0377649, 0377896, 0378000, 0378124, 0378126, 0378137, 0378273, 0378357, 0378396, 0378414, 0378499, 0378506, 0378556, 0378590, 0378594, 0378596, 0378816, 0378842, 0378845, 0378983, 0379081, 0379088, 0379242, 0379272, 0379306, 0379424, 0379670, 0379764, 0379827, 0379843, 0379867, 0379868, 0379901, 0379922, 0379923, 0379929, 0380109, 0380216, 0380313, 0380354, 0380606, 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C0393397, C0393420, C0393433, C0393481, C0393482, C0393979, C0394056, C0394291, C0394292, C0394293, C0394294, C0394470, C0394521, C0394679, C0394726, C0395056, C0395070, C0395072, C0395081, C0395166, C0395283, C0395384, C0395450, C0395480, C0395482, C0395484, C0395486, C0395511, C0395513, C0395639, C0395983, C0395984, C0396021 C0396105, C0396111, C0396124, C0396896, C0397006, C0397127 C0397170, C0397177, C0397343, C0397388, C0397391, C0397576, C0397641, C0397716, C0397738, C0397746, C0397920, C0397957, C0398187, C0398245, C0398246, C0398247, C0398248, C0398249, C0398657, C0398731, C0398769, C0399089, C0399138, C0399159, C0399182, C0399450, C0399451, C0399452, C0399453, C0399514, C0399516, C0399517, C0399622, C0399624, C0399643, C0399996, C0400022, C0400093, C0400130, C0400137, C0400144, C0400147, C0400153, C0400156, C0400159, C0400160, C0400161, C0400163, C0400166, C0400199, C0400208, C0400262, C0400305, C0400340, C0400346, C0400354, C0400355, C0400356, C0400378, C0400400, C0400426, C0400479, C0400492, C0400572, C0400655, C0400684, C0400691, C0400866, C0400873, C0400879, C0400887, C0400915, C0401377, C0401379, C0401411, C0401422, C0401457, C0401536, C0401676, C0401750, C0401879, C0401882, C0401885, C0401886, C0401980, C0402065, C0402098, C0402187, C0402233, C0402264, C0402338, C0402596, C0402608, C0402677, C0402703, C0402984, C0403242, C0403295, C0403509, C0403513, C0403598, C0403601, C0403604, C0403613, C0403648, C0403775, C0403827, C0403833, C0403839, C0403841, C0403842, C0403843, C0403845, C0403846, C0403852, C0403928, C0403949, C0404000, C0404007, C0404028, C0404072, C0404127, C0404311, C0404342, C0404445, C0404492, C0404498, C0404505, C0404591, C0404773, C0404774, C0404776, C0404780, C0404784, C0404791, C0404980, C0404981, C0404987, C0405008, C0405009, C0405010, C0405011, C0405014, C0405015, C0405088, C0405212, C0405295, C0405344, C0405442, C0405496, C0405550, C0405813, C0405873, C0405877, C0405981, C0406004, C0406007, C0406009, C0406014, C0406018, C0406020, C0406022, C0406024, C0406026, C0406028, C0406030, C0406100, C0406276, C0406309, C0406324, C0406386, C0406421, C0406432, C0406572, C0406751, C0406781, C0406785, C0406792, C0406831, C0406872, C0406955, C0406978, C0407080, C0407256, C0407788, C0407814, C0407884, C0407942, C0408003, C0408210, C0408589, C0408754, C0408805, C0409092, C0409122, C0409443, C0409775, C0409777, N0388420, N0398607 Class II Franck's Lab Inc. d.b.a. Franck's initiated a recall of all Sterile Veterinary Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared. Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Devices Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration. Pump Model Numbers: 8713050U, 8713050U-99, 8713050US, 8713060U, and 8713060U-99 -- various serial numbers. Class I Firm became aware of the potential for breakage of the anti free flow clip catch, located on the inside of the pump door, when the IV set anti free flow clip is incorrectly inserted into the pump and the pump door forced closed. If the clip catch is broken and the door opened, free flow protection is still ensured. However, after the set is manually removed from the pump without the closure of the IV set roller clamp, the anti free flow clip may not re-engage the tubing thereby leaving an open fluid path and creating a potential for free flow. When the pump and IV set are operated in accordance with the Instructions for Use (IFU), any potential for free flow is fully mitigated. From the time the set is properly inserted into the pump to the time the set is removed from the pump, the pump's free flow protection remains activated regardless of the integrity of the clip catch. Additionally, as described in the IFU, the roller clamp should always remain closed after priming the line until the set is properly inserted into the pump. A warning light is present inside the pump which only turns off once the IV set anti free flow clip is properly positioned in the clip channel in the pump. Further, per the IFU, the roller clamp is to be closed at the end of infusions before disconnecting the patient. Adherence to the IFU by the user mitigates the risk of potential free flow should the clip catch be broken. The original report of correction informed the Agency of a retrospective upgrade conducted at 14 customer accounts that consisted of a new hardware component intended to act as a door jam and a new software version G03. B. Braun is expanding this field correction to include the following additional actions: -- Customers with Infusomat Space Pumps with software versions G02 and prior are being informed of the importance of following the Instructions for Use in order to avoid potential IV set misloading and are being provided with information regarding the potential risks should the IFU not be followed. Included in the letters to these customers are necessary user actions to ensure proper IV set loading and unloading, as well as user recommendations. Proper use guides in the form of a poster and a DVD are also being provided with these letters to B. Braun customers. -- All pumps in the market, which included pumps with G03, G02 and prior software versions, are being upgraded to a metal clip catch. This new material strengthens the clip catch and eliminates potential for breakage of the current clip catch which is fabricated from plastic. During the upgrade process of pumps with G03 software where the door jam was previously installed, the door jam will be removed from the pump. The original intent of the door jam was to minimize potential for breakage, but did not eliminate possible breakage when high forces are applied. B. Braun Medical, Inc.
Devices GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004. Product ID Number Lot Code 2016995-001 xxxx2010E 2016995-002 xxxx2010D 2016995-003 xxxx2010C 2016995-004 xxxx2010C Class II GE Healthcare has become aware through complaints of a potential safety issue with its Invasive Blood Pressure Cable made for use with a Spectramed / BD invasive blood pressure transducer. Due to use of an incorrect O-ring, the mating of the cable with the transducer is faulty. This situation inhibits blood pressure measurement from being monitored correctly. GE Healthcare, LLC
Devices Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. BC-1065 (US distribution) Lot No. RN-43116-4 BC-1065 E (European Distribution) Lot No. RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, RN-43116-3. Class III The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits. Critical Diagnostics
Devices Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient. Catalog #425-00, 425-10 and 425-30. Class II Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment. Teleflex Medical
Devices Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results. Lot/Unit Codes: W50216B, W50222B, W50245B, W50250B, W50809B, W50810B, W50812B, W50813B, W50816B, W50817B, W50818B, W50819B, W50820B, W50821B, W50822B, W50823B, W50826B, W50829B, W50830B, W50831B, W50832B, W50837B, W50838B, W50842B, W50843B, W50844B, W50846B, W50848B, W50851B, W50862B, W50866B, W50869B, W50870B, W50871B, W50872B, W50873B. Class II A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen. Alere San Diego, Inc.
Food SunOpta, Canadian Harvest Oat Fiber, Oat Fiber 300-33, Manufactured by SunOpta Ingredients, Chelmsford, MA 01824 22211314AA 22211315AA 22211316AA 22211317AA and 22211318AA was reworked into Lots 22211339DD, 22211342DD, 22211343DD, 22211344DD, 22211346DD, 22211347DD, and 22211350DD EXPANDED 06/21/2012 to include more lots: 22211311AA, 22211312AA, 22211313AA, 22211353DD EXPANDED 06/26/2012 to include more lots: 22211354DD Class II SunOpta Ingredients Group, Cambridge, MN is voluntarily withdrawing from the market a number of lots of Canadian Harvest® Oat Fiber 300-33 because of the possible contamination caused by Cronobactor sakazakii. SunOpta Ingredients Group (Corporate HQ)
Devices Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language. list numbers 06L88-02, 06L88-03, 06L88-04, 06L88-05, 06L88-06, 06L88-07, 06L88-08 and 06L88-09, all lots Class II In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar code scanner language format. The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories. It is comprised of the Abbott m2000sp and the Abbott m2000rt instruments. Abbott Molecular
Food Truitt Brothers, Pacific Northwest Premium Navy Beans, net weight 15 oz. per metal can. The UPC is 0 82225 24145 1. The product is labeled in parts: "***TRUITT BROTHERS***Pacific Northwest PREMIUM NAVY BEANS***NET WT 15 OZ***INGREDIENTS: NAVY BEANS, WATER, SEA SALT, NATURAL CALCIUM CHLORIDE***TRUITT BROS., INC.***SALEM, OREGON 97308***www.truittbros.com***www.foodalliance.org***". Can code: MDSB S1GTD best by 7/18/14. Code interpretation: MDSB is the internal code for this product. S = Salem, 1 = Year (2011), G = month, T = Day, D = Shift (of manufacture). Best by date is 7/18/14 (3 year shelf life) Class II Navy Beans with the can code MDSB S1GTD best by 7/18/14 are recalled due to undeclared soy. Truitt Bros,. Inc discovered that some canned chili beans were labeled as Navy Beans and soy was not declared on the Navy Beans label. Truitt Bros., Inc.
Devices LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment 2009 Lot # 90923A, 91222A. 2010 Lot# 00327A, 00518A, 00623A, 00831B, 01013A, 01103A, 01214A. 2011 Lot# 10110A, 10301B, 10423A, 10530A, 10602A, 10703A, 10804A, 11004A. 2012 Lot# 120104, 120414. Class II The recall was initiated because LMANA has received a complaint that the Esophageal Intubation Detector (EID100) has a potential to create a false positive if used on a patient during confirmation of intubation. LMA North America Inc
Food Itoen Green Tea 11.5 fl oz (340 mL) can. Natural Source of Antioxidants; 0 calories, no sugar: ITO-EN USA Inc. 125 Puuhale Road Honolulu, HI 96819 IHAPR1013; Costo item number 17800; Brown carboard tray side 1: GREEN TEA 041012 Brown cardboard side 2: GT 041013 Class II ITO EN discovered that unretorted product was inadvertently released for distribution. Itoen (USA) Inc
Devices CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use. serial numbers: 26562, 43634, 43642, 43643, 44536, 44537, 44540, 44541, 44542, 44543, 44544, 44545, 44546, 44552, 44553, 44554, 44555, 44557, 44558, 44559, 44560, 44561, 44562, 44563, 44564, 44565, 45318, 45320, 45321, 45322, 45323, 45324, 45325, 45326, 45327, 45328, 45329, 45330, 45333, 45334, 45335, 45336, 45337, 45338, 45339, 45340, 45341, 45342, 45343, 45344, 45345, 45346, 45735, 45736, 45737, 45738, 45739, 45740, 45741, 45742, 45743, 45744, 45745, 45746, 45748, 45750, 45751, 45752, 45753, 45754, 45902, 45903, 45904, 45905, 45906, 45907, 45908, 45909, 45910, 45911, 46038, 46039, 46040, 46041, 46042, 46043, 46044, 46045, 46046, 46047, 46048, 46049, 46050, 46051, 46052, 46632, 46634, 46635, 46636, 46637, 46638, 46639, 46640, 46641, 46642, 46643, 46644, 46645, 47069, 47070, 47071, 47073, 47074, 47075, 47076, 47077, 47078, 47079, 47080, 47081, 47082, 47083, 47210, 47211, 47212, 47213, 47214, 47215, 47216, 47217, 47219, 47221, 47222, 47223, 47225, 47226, 47227, 47229, 47230, 47231, 47232, 47233, 47234, 47236, 47237, 47238, 47239, 47538, 47539, 47540, 47541, 47542, 47543, 47544, 47545, 47546, 47547, 47548, 47549, 47550, 47551, 47552, 47553, 47554, 47555, 47556, 47557, 47558, 47559, 47560, 47561, 47562, 47563, 47564, 47565, 47566, 47567, 48759, 48760, 48761, 48762, 48763, 48764, 48765, 48766, 48767, 48768, 48769, 48770, 48771, 48772, 48773, 48774, 48775, 48776, 48777, 48778, 48779, 48780, 48781, 48782, 48783, 48784, 48785, 48786, 48787, 48788, 48868, 48869, 48870, 48871, 48872, 48873, 48874, 48875, 48876, 48878, 48881, 48883, 48884, 48885, 48886, 48887, 48889, 48890, 48891, 48892, 48893, 48894, 48895, 48897, 50390, 50391, 50392, 50393, 50394, 50395, 50397, 50409, 50411, 50412, 50416, 50417, 50418, 50419, 50648, 50650, 50651, 50652, 50654, 50656, 50657, 50658, 50659, 50660, 50661, 50662, 50663, 50664, 50665, 50666, 50667, 50668, 50672, 51569, 51574 Class I CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised. CareFusion 203, Inc.
Devices Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide additional information. Post processing capabilities included in the Scenaria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering. Serial #'s S5001 - S5011 Class II Hitachi discovered a software error in the Reconstruction Status function that creates a potential risk that a patient study will not be fully reconstructed. When multiple reconstructions are queued for processing, if a queue is suspended and the task order changed, the second queue may not reconstruct the full range of slices. This may result in missing diagnostic data. Hitachi Medical Systems America Inc
Devices OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgery technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray. Part numbers: 00-887200-01; 00-887200-03; 00-887201-01; 00-887201-03; 00-887202-01; 00-887202-03; 00-887204-03; 00-887207-03; 00-887206-03. Along with all associated serial numbers. Class II GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure. GE OEC Medical Systems, Inc
Devices OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm System designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion. Part numbers: 00-884909-01, 00-884777-01, 00-884911-01, 00-885553-01, 00-884913-01, 00-885554-01, 00-885555-01, 00-886289-01. All serial numbers. Class II GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure. GE OEC Medical Systems, Inc
Devices OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The OEC 8800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion. Part numbers: OEC 8800 All serial numbers. Class II GE OEC recalled imaging devices OEC 9900, OEC 9800, and OEC 8800 as a result of an FDA inspection identifying that the vertical lift column power supply in the mainframe C-arm is defective and subject to early life failure. GE OEC Medical Systems, Inc
Devices GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light. Serial Numbers: 12208, 12209 12204 12855 13023 13102 12203 12210 13117 13258 12202 12201 13416 13489 12199, 13488 12198 12200 13499 12195, 13612 13607 14186 13610 13609 14184 14059, 14060 14164, 14165 14185 14190 14330 14333 14395, 14396, 14397 14485 14509 14508 14559 14580 14670, 14671, 14672 14680, 14681 14690 - 14699 14909, 14910 14983 14986 14985 14987 14984 14988 15708 14989 14990 16209 16207 16206 16208 16211 16489 16648 17466 16488 16487 16793, 16794 16237 17051 17052 17186, 17187, 17188 17014 17288-17289 17476 17467 17464 17321-17324 17860-17861 17899 17898 17506 18452 18451 17903 17901 17889 17891 17890 17888 20854 20860 17902 21095-21096 20856, 20858, 20859 20420 17900 20387 20855, 20857 20386 20357, 20358 20359 20029, 20030, 20360, 23813, 23814 20385 24462 24597, 24600 24663 25321 25513, 25518 25515 20384 26650, 25514, 25516, 25517 26651, 26652 26653, 26654, 26655 20388 20383 27460 - 27463 20388 20383 27825, 27826 28661, 28664 Class II The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference. Gulf Fiberoptics, Inc.
Devices Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye. H480110 ,H486186 ,H48B178 ,H48D026 ,H48D966 ,H487806 ,H48B764 ,H48B218 ,H48C503 ,H488467 ,H481815 ,H48D923 ,H48E486 ,H480267 ,H486446 ,H48B179 ,H48D027 ,H48A565 ,H487807 ,H48B765 ,H48B963 ,H48B756 ,H488468 ,H481816 ,H48E896 ,H48B426 ,H480268 ,H486447 ,H48B180 ,H48D028 ,H48A566 ,H487808 ,H482178 ,H48B964 ,H48B757 ,H489917 ,H485467 ,H48E897 ,H48B668 ,H480269 ,H487164 ,H48B181 ,H48D029 ,H48D566 ,H487809 ,H489962 ,H48B965 ,H482450 ,H48A912 ,H48A254 ,H489213 ,H48B669 ,H480270 ,H487165 ,H48B182 ,H48D030 ,H488558 ,H487810 ,H489963 ,H48B966 ,H482451 ,H48A913 ,H48C429 ,H489214 ,H48B670 ,H480271 ,H487166 ,H48B183 ,H48D031 ,H488559 ,H48D203 ,H48C022 ,H48C177 ,H482452 ,H48A914 ,H48B523 ,H489215 ,H48B671 ,H480272 ,H487167 ,H48B184 ,H48D032 ,H488560 ,H48D204 ,H48E169 ,H48C178 ,H483272 ,H48A915 ,H48B524 ,H484763 ,H48B672 ,H482174 ,H487168 ,H48B185 ,H48D033 ,H488561 ,H48D361 ,H48E170 ,H48C179 ,H484360 ,H48A916 ,H48B525 ,H484764 ,H48B673 ,H482934 ,H487169 ,H48B186 ,H481109 ,H489079 ,H48D362 ,H48E171 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,H484523 ,H487016 ,H48D690 ,H48A045 ,H487615 ,H486179 ,H480862 ,H48C995 ,H487495 ,H48C892 ,H48B067 ,H48C576 ,H481596 ,H484524 ,H487017 ,H48A279 ,H48A046 ,H48C378 ,H486180 ,H480863 ,H48C996 ,H487496 ,H481678 ,H48B068 ,H485345 ,H48B607 ,H485052 ,H48C122 ,H48A280 ,H48A828 ,H48C379 ,H486181 ,H486828 ,H48C997 ,H484128 ,H481679 ,H48B069 ,H489646 ,H48B608 ,H487256 ,H48C123 ,H48A281 ,H48A849 ,H48C380 ,H486182 ,H48A195 ,H48B335 ,H484129 ,H481680 ,H48D669 ,H48D449 ,H48B609 ,H487257 ,H48C124 ,H48A541 ,H48D146 ,H482374 ,H486183 ,H482166 ,H48B336 ,H484130 ,H482115 ,H48A446 ,H48A797 ,H48B610 ,H487258 ,H48C125 ,H487470 ,H48D270 ,H486627 ,H485463 ,H482167 ,H48B340 ,H484131 ,H482602 ,H48A447 ,H48A798 ,H48B611 ,H487259 ,H48C126 ,H484119 ,H48D271 ,H48D413 ,H485602 ,H482168 ,H48B341 ,H484132 ,H482792 ,H48A925 ,H48D726 ,H48B612 ,H487260 ,H48C127 ,H48D638 ,H48D272 ,H480673 ,H488720 ,H482169 ,H48B342 ,H484133 ,H483694 ,H489649 ,H48D733 ,H480859 ,H480102 ,H48B489 ,H486218 ,H482059 ,H482539 ,H48E016 ,H48B351 ,H489147 ,H48A510 ,H487888 ,H481467 ,H48C083 ,H480103 ,H48B490 ,H486945 ,H482060 ,H489617 ,H487549 ,H48B352 ,H489950 ,H48A511 ,H488697 ,H481468 ,H48B695 ,H480712 ,H48B491 ,H48E765 ,H482061 ,H48B308 ,H487550 ,H480514 ,H48B022 ,H48D918 ,H488789 ,H482290 ,H481798 ,H481104 ,H48C173 ,H480785 ,H482062 ,H481066 ,H480247 ,H480679 ,H48C321 ,H48D919 ,H488790 ,H482694 ,H481799 ,H481105 ,H48C174 ,H480786 ,H482063 ,H481067 ,H482765 ,H483331 ,H48C322 ,H48D920 ,H488791 ,H485814 ,H485709 ,H487617 ,H48D081 ,H486805 ,H482074 ,H48D239 ,H489162 ,H483333 ,H487864 ,H48D921 ,H48B362 ,H488571 ,H485710 ,H488829 ,H48D671 ,H48B263 ,H482075 ,H48D240 ,H489163 ,H483334 ,H48D683 ,H480787 ,H48B363 ,H48A289 ,H485929 ,H489908 ,H48D672 ,H482641 ,H482076 ,H48D241 ,H489164 ,H486980 ,H48D743 ,H485589 ,H48B557 ,H48A290 ,H488573 ,H489909 ,H488144 ,H486068 ,H482077 ,H48D242 ,H48A618 ,H487386 ,H48D744 ,H487229 ,H48C824 ,H48B697 ,H48D343 ,H489910 ,H487990 ,H487925 ,H482078 ,H48D929 ,H48A619 ,H487387 ,H48D745 ,H487488 ,H48C825 ,H48B698 ,H48D439 ,H486278 ,H488898 ,H487926 ,H482079 ,H483060 ,H48A620 ,H48E434 ,H48D746 ,H487489 ,H48C826 ,H48E491 ,H48D447 ,H486279 ,H48D868 ,H48C642 ,H482080 ,H483061 ,H48A621 ,H48E435 ,H48D747 ,H487490 ,H48C827 ,H48E492 ,H48D450 ,H486280 ,H48D869 ,H48C643 ,H482081 ,H483062 ,H48A622 ,H486316 ,H48D748 ,H487491 ,H48C828 ,H481164 ,H48D732 ,H486282 ,H48A317 ,H48C644 ,H482082 ,H483284 ,H48A623 ,H486430 ,H48D749 ,H48A126 ,H48D870 ,H481165 ,H48A564 ,H48C277 ,H48D044 ,H48C645 ,H482083 ,H483285 ,H481229 ,H486431 ,H48D750 ,H48E604 ,H48A640 ,H481166 ,H487286 ,H483485 ,H487574 ,H48C646 ,H482084 ,H487531 ,H481230 ,H486432 ,H48D751 ,H48E605 ,H48A641 ,H481171 ,H487287 ,H483486 ,H487581 ,H48C647 ,H482085 ,H482587 ,H481231 ,H486433 ,H48D764 ,H482709 ,H48A642 ,H481172 ,H487288 ,H485660 ,H487582 ,H48C648 ,H482086 ,H482588 ,H488018 ,H48D552 ,H485290 ,H483611 ,H48A643 ,H485689 ,H487289 ,H485661 ,H487583 ,H48C649 ,H482087 ,H483546 ,H488019 ,H48D801 ,H488271 ,H483817 ,H48A644 ,H485690 ,H487290 ,H48E776 ,H48C717 ,H48C650 ,H482088 ,H484431 ,H488400 ,H480333 ,H488272 ,H48B366 ,H481500 ,H485691 ,H48A048 ,H48D130 ,H48C718 ,H48C651 ,H482089 ,H48A132 ,H489826 ,H480334 ,H488273 ,H48B368 ,H488763 ,H48B216 ,H48A049 ,H48D131 ,H480056 ,H48C652 ,H482090 ,H48C368 ,H48B651 ,H480335 ,H488274 ,H48B845 ,H488764 ,H489452 ,H481381 ,H48D132 ,H480057 ,H48C653 ,H482091 ,H48C691 ,H48C657 ,H483433 ,H488336 ,H480400 ,H488775 ,H489453 ,H481382 ,H48D133 ,H480058 ,H48D300 ,H482092 ,H48C692 ,H48D293 ,H487868 ,H488668 ,H481037 ,H488776 ,H489454 ,H481383 ,H48D134 ,H480059 ,H48D301 ,H482093 ,H486317 ,H48A309 ,H487897 ,H488669 ,H481056 ,H489869 ,H489455 ,H481606 ,H48D135 ,H480060 ,H48D302 ,H482104 ,H486318 ,H483943 ,H487903 ,H488672 ,H482413 ,H489870 ,H489456 ,H483705 ,H488708 ,H480061 ,H48D304 ,H482105 ,H486491 ,H487999 ,H487904 ,H488673 ,H482414 ,H489871 ,H489457 ,H486842 ,H488709 ,H480062 ,H48D308 ,H482106 ,H487959 ,H488005 ,H487905 ,H488674 ,H482415 ,H482842 ,H489458 ,H486843 ,H488710 ,H487579 ,H48D310 ,H482107 ,H487960 ,H489095 ,H480427 ,H488676 ,H482416 ,H482843 ,H489459 ,H486844 ,H488711 ,H480775 ,H48D312 ,H482108 ,H489986 ,H489096 ,H480428 ,H488677 ,H482417 ,H484967 ,H48E777 ,H486845 ,H486057 ,H481408 ,H48D313 ,H482109 ,H489987 ,H489097 ,H480429 ,H488678 ,H484587 ,H48C961 ,H48E778 ,H486846 ,H486629 ,H481409 ,H48D314 ,H482110 ,H48E309 ,H481526 ,H480430 ,H488679 ,H485394 ,H48C962 ,H48B754 ,H486630 ,H481410 ,H48D335 ,H482111 ,H48E312 ,H481527 ,H481805 ,H488680 ,H485395 ,H48C963 ,H48B766 ,H486631 ,H481411 ,H480989 ,H482112 ,H48D298 ,H481528 ,H481806 ,H488681 ,H486602 ,H48C964 ,H48B767 ,H486632 ,H481412 ,H481984 ,H482113 ,H48D299 ,H481529 ,H483448 ,H488682 ,H486800 ,H481312 ,H48B768 ,H48B385 ,H481523 ,H481985 ,H482262 ,H48C811 ,H487401 ,H483450 ,H488683 ,H486801 ,H481313 ,H48C874 ,H481003 ,H481783 ,H481986 ,H482346 ,H48C812 ,H487402 ,H48E939 ,H488684 ,H486802 ,H481314 ,H48B280 ,H481004 ,H481784 ,H481987 ,H482347 ,H48C813 ,H488150 ,H48B828 ,H488685 ,H487650 ,H482937 ,H48A601 ,H481069 ,H485078 ,H481988 ,H482348 ,H48C814 ,H488151 ,H48B829 ,H488686 ,H487651 ,H485928 ,H48B738 ,H482518 ,H485315 ,H481989 ,H482349 ,H48C815 ,H488152 ,H48B830 ,H488687 ,H487652 ,H48E588 ,H485776 ,H483816 ,H486966 ,H481990 ,H482350 ,H48C816 ,H488153 ,H48B831 ,H488688 ,H487653 ,H489260 ,H485777 ,H48B172 ,H487343 ,H481991 ,H482351 ,H48C817 ,H488154 ,H48B832 ,H488689 ,H487654 ,H489261 ,H486498 ,H48C152 ,H487344 ,H481992 ,H482397 ,H48C819 ,H488155 ,H48B833 ,H488690 ,H487655 ,H489262 ,H486499 ,H48C153 ,H487345 ,H481993 ,H482398 ,H48C820 ,H488156 ,H48C462 ,H488691 ,H487656 ,H485079 ,H489144 ,H48C154 ,H487346 ,H481994 ,H482399 ,H48C863 ,H488157 ,H48D493 ,H488692 ,H487657 ,H48B389 ,H489379 ,H48D403 ,H487347 ,H482002 ,H484114 ,H48E639 ,H488158 ,H482876 ,H488693 ,H48D285 ,H48B390 ,H48A986 ,H48D404 ,H48D250 ,H482005 ,H484446 ,H48E640 ,H488159 ,H482877 ,H488694 ,H48D604 ,H48B391 ,H48A987 ,H484216 ,H48C470 ,H482008 ,H484447 ,H480923 ,H489932 ,H482878 ,H488696 ,H48D605 ,H48B392 ,H488576 ,H484217 ,H48C471 ,H482009 ,H484448 ,H480924 ,H48A683 ,H482879 ,H488929 ,H48D606 ,H485706 ,H488577 ,H484218 ,H48C472 ,H482012 ,H484449 ,H480925 ,H48A684 ,H487518 ,H488930 ,H48D607 ,H485707 ,H485372 ,H484219 ,H48C473 ,H482013 ,H484549 ,H488802 ,H48D381 ,H487519 ,H488931 ,H48D608 ,H485708 ,H485373 ,H484220 ,H48C474 ,H482024 ,H488230 ,H488803 ,H48E915 ,H487520 ,H488932 ,H48D609 ,H48B247 ,H48B098 ,H487729 ,H48C475 ,H482026 ,H488783 ,H488806 ,H48E916 ,H489560 ,H488933 ,H48D610 ,H48C926 ,H48B099 ,H487730 ,H48B892 ,H482028 ,H488784 ,H488807 ,H485541 ,H48B423 ,H488934 ,H482835 ,H48C927 ,H48B100 ,H487731 ,H48B893 ,H482030 ,H488785 ,H488808 ,H485542 ,H480177 ,H488935 ,H482836 ,H48C928 ,H48B101 ,H48C786 ,H484419 ,H482032 ,H488786 ,H488810 ,H486442 ,H480178 ,H489854 ,H483120 ,H48C929 ,H48B102 ,H481835 ,H48A671 ,H482042 ,H488787 ,H488812 ,H486443 ,H480179 ,H48B030 ,H485259 ,H480019 ,H48B103 ,H481836 ,H484622 ,H482054 ,H48B739 ,H488813 ,H487992 ,H480287 ,H48B031 ,H485260 ,H480020 Class II Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect the intended prescription. Varian Medical Systems, Inc. Oncology Systems
Devices Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors. The Spacelabs Healthcare Xprezzon Bedside Monitor is designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Xprezzon Bedside Monitors is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. 040-1632-00; 1393-000013; 1393-000039; 1393-000040; 1393-000041; 1393-000341; 1393-000382; 1393-000383; 1393-000384; 1393-000385; 1393-000386; 1393-000387; 1393-000388; 1393-000808; 1393-000831; 1393-001374; 1393-001375; 1393-001453; 1393-001990; 1393-001991; and 1393-001992. Class II There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power cycling the monitor. Spacelabs Healthcare, Llc
Devices MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. Product Code: 92340 (Large), Lot #AH9103, AH9110, AH9139, AH9140, AG9154, AH9155 and AH9160; Product Code: 92342 (X-Large), Lot #AH9116, AH9142, AH9143, AH9145, AH9150, AH9151, AH9155, AH9157, AH9159, AH9160, AH9166, AH9168 and AH9076. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number 92340 (Large), Lot numbers: AH9072, AH9073, AH9074, AH9103, AH9140 and AH9146; Product number: 92342 (X-Large), Lot numbers: AH9073, AH9074, AH9112, AH9158, AH9160, AH9163, AH9165, AH9167 and AH9168; Product number: 92344 (XX-Large), Lot numbers: AH9074, AH9139, AH9152, AH9153, and AH9155; Product number: 92353 (X-Large Specialty), Lot numbers: AH9143, AH9146 and AH9160 and Product number: 92357 (XX-Large Specialty), Lot number range AH9072xxx to AH9175xxx. Class II Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. Kimberly-Clark Corporation
Devices MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter. Product Code: 92354 (Secure-Fit Large), Lot #AH9141 and Product Code: 92355 (Secure Fit X-Large), Lot #AH9143. Customers were notified to include Lot range AH9076xxx to AH9175xxx. On November 17, 2009 the recall was expanded to include the following: Product number: 92354 (Large), Lot number range AH9072xxx to AH9175xxx; Product number: 92355 (X-Large), Lot number: AH9141 and Product number: 92358 (XX-Large), Lot number: AH9173. Class II Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns. Kimberly-Clark Corporation
Devices Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04; Lot numbers: 22737521, 22924079, 23427293, 23536123, 24076552, 24435084, 24435084, 24750543, 25088133, 25275511, 25598563, 26476576, 26924324, 26959148, 27264233, 27526176, 27756781, 27756781, 28238361, 28481694 GEO-MED TOTAL HIP PACK, REF 89-6664.03; Lot numbers: 22924204, 23623163, 23880637, 24076691, 24162522, 24295421, 24585728, 24600836, 24900118, 25030484, 25144351, 25461743, 25559311, 26021993, 26064301, 27526328, 28262740 Class II Surgical kits and trays contain Stryker Hytrel Togas which were recalled because the clear tape, that is intended to aid in the prevention of patient's fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. DeRoyal Industries Inc
Devices Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon. Model number 643350 -- batch numbers 1045878, 1045879, 1045881, 1045880, 1045872, 1045882, 1045876, 1045877, 1045873, 1045874, and 1045875. Model number 643425 -- batch numbers 1045890, 1045886, 1045884, 1045887, 1045888, 1045889, and 1045885. Model number 643650 -- batch numbers 1045891, 1045892, and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895. Class II The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification. Integra Limited
Food SP Standard Process, Cataplex ACP (Product #0700 and 0750) , Dietary supplement, 90 & 360 Tablets, Proprietary Blend: Dried buckwheat ( leaf) juice, buckwheat (seed), carrot (root), calcium lactate, nutritional yeast, bovine adrenal, bovine kidney, alfalfa flour, dried alfalfa, (whole plant) juice, magnesium citrate, mushroom, bovine bone, Echinacea (root, deflated wheat, (germ), oat flour, soybean lecithin, yeast bone, calcium acid, phosphate, mixed tocopherols, (soy), rice (bran), and carrot oil., Other ingredients: Honey ascorbic acid, calcium stearate, arabic, gum, starch, sucrose, vitamin A palmate., UPC 8 12122 01003 0 18. Lot 114, Lot 114, Best Used By dates of 05/13. Class I Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination. Standard Process, Inc.
Food SP Standard Process, Cataplex C, Dietary Supplement, (Product # 1650 and 1655) , 90 & 360 Tablets, Proprietary Blend: Veal bone PMG extract, bovine adrenal, dried buckwheat (leaf) juice, buckwheat (seed), nutritional yeast, dried alfalfa( whole plant) juice, alfalfa flour, mushroom , magnesium citrate, bovine bone, deflated wheat (germ), calcium acid phosphate, Echinacea(root), carrot (root), veal bone, soybean lecithin, mixed tocopherols (soy , and rice (bran)., Other Ingredients calcium lactate, honey, aerola (berry), camu camu (berry), manloc (root), calcium stearate, and arabic gum, UPC 8 12122 01029 0 16. Lot 114, Lot 114, Best Used By dates of 05/13. Class I Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination. Standard Process, Inc.
Food Standard Process, Pancreatrophin PMG (Product # 6650), 90 Tablets, Proprietary Blend: Bovine pancreas PMG extract, dried alfalfa (whole plant) juice, nutritional yeast, porcine duodenum, deflated wheat (gem) , dried buckwheat (leaf) juice and buckwheat (seed). Other Ingredients: Arabic gum and calcium stearate. Standard Process Inc., PO Box 904, Palmyra, WI 59158, UPC 8 12122 01153 2 12. Lot 114, Best Used By dates of 05/13. Class I Standard Process, Inc. is voluntarily recalling 3 dietary supplements due to potential Salmonella contamination. Standard Process, Inc.
Drugs HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4. Lot #s: L030F11A, L054F11A, Exp 05/13; L095E10A, Exp 06/13; L079J10A, L085K11A, L086K11A, L087G10A, L087K11A, L088K11A, Exp 10/13; L094L10A, Exp 12/13; and L100L10B, Exp 01/14 Class III Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point. Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Devices GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR ) Model Numbers Optima XR200 15kw Optima XR 200 30kw Optima XR 220 15kw Optima XR 220 30kw Class II GE Healthcare hos become aware of o software issue on the interfoce of the mobile radiogrophic product, Optima XR200amx, ond Optima XR22Oamx reloted to Visual indicotion as mandoted by the US Code of Federol Regulations (21CFR) and IEC 60601-1-3. GE Healthcare, LLC
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