FDAFDA · Alimentos y medicamentos·N.º oficial Z-0994-2014
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Publicado el 26 de febrero de 2014 · Inicio del retiro: 5 de diciembre de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Integra LifeSciences Corp.
- Distribuidor
- Worldwide Distribution - USA Nationwide
- Lote
- All unexpired lot numbers for CEM Nosecone Gatalouge No. C6623 and C6636 from 1/1/2010 to present. CEM" Nosecone, Catalogue No. C6623: 1083655, 1084219, 1084398, 1084399, 1084400, 1084682, 1084683, 1090937, 1091712, 1091714, 1091715, 1093125, 1093126, 1093128, 1093129, 1093471, 1093847, 1094575, 1094740, 1095587, 1095873, 1100237, 1100238, 1101217, 1101547, 1101548, 1102069, 1102070, 1102544, 1102545, 1102546, 1103102, 1103392, 1103444, 1103445, 1103446, 1104264, 1104265, 1105065, 1105066, 1105067, 1110208, 1110311, 1110348, 1110349, 1110473, 1110474, 1110892, 1111760, 1112182, 1112808, 1112809, 1113175, 1113176, 1113177, 1113178, 1113662, 1114112, 1114654, 1114655, 1114656, 1115224, 1115225, 1115499, 1115500, 1115501, 1115853, 1115854, 1120771, 1120772, 1120773, 1120774, 1121141, 1121142, 1121383, 1121627, 1121628, 1122257, 1122259, 1122260, 1123050, 1123312, 1123915, 1124642, 1124643, 1124980, 1125393, 1125394, 1125933, 1130036, 1130037, 1130038, 1130039, 1130218, 1130219, 1130663, 1130664, 1131340, 1131344, 1131986, 1132207, 1132326, 1132327, 1132328, 1132880 CEM" Nosecone, Catalogue No. C6636: 1084216, 1084293, 1084377, 1084680, 1084681, 1090123, 1090124, 1090125, 1090126, 1090660, 1090661, 1090826, 1091395, 1091434, 1091700, 1092388, 1092389, 1092390, 1092391, 1092392, 1093012, 1093013, 1093130, 1093131, 1093472, 1093473, 1093474, 1093824, 1093825, 1093826, 1093827, 1094741, 1095104, 1095105, 1095106, 1095414, 1095415, 1095418, 1095419, 1100239, 1100240, 1100241, 1101220, 1101221, 1102647, 1102648, 1102649, 1102650, 1102651, 1103103, 1103394, 1103395, 1103437, 1103848, 1103851, 1103916, 1103917, 1103919, 1103920, 1103921, 1103922, 1104258, 1104259, 1104260, 1104261, 1104262, 1105068, 1105069, 1105070, 1110333, 1110975, 1110976, 1110977, 1111491, 1111492, 1111493, 1112186, 1112187, 1112211, 1112212, 1112769, 1112770, 1112771, 1113180, 1113181, 1113182, 1113183, 1113184, 1113664, 1113665, 1113666, 1114358, 1114359, 1114657, 1114658, 1114659, 1114660, 1115036, 1115037, 1115038, 1115039, 1115503, 1115504, 1115505, 1115855, 1115856, 1115857, 1115858, 1115859, 1115860, 1120360, 1120361, 1120362, 1120775, 1120776, 1120777, 1121568, 1121729, 1122344, 1122346, 1122347, 1123053, 1123054, 1123497, 1123498, 1123499, 1123500, 1123501, 1124054, 1124055, 1124703, 1124704, 1124705, 1124706, 1124707, 1124710, 1125395, 1125396, 1125397, 1125398, 1125399, 1125400, 1125476, 1125934, 1125935, 1125936, 1125937, 1125938, 1125939, 1130220, 1130221, 1130222, 1130223, 1130834, 1131243, 1131987, 1132777, 1132778, 1132779, 1132780, 1132879, 1133061, 1103850, 1103852, 1103917, 1103918, 1103922, 1104257, 1104263, 1105071, 1110475, 1110476, 1110978, 1111490, 1111493, 1112187, 1112188, 1112212, 1113179, 1113180, 1113663, 1114357, 1114358, 1114659, 1114660, 1115039, 1115502, 1115504, 1115505, 1120776, 1120777, 1121167, 1121168, 1121169, 1121565, 1121566, 1121567, 1122344, 1122743, 1123051, 1123052, 1123497, 1123498, 1123499, 1123500, 1123501, 1123508, 1123509, 1123510, 1123511, 1123512, 1124052, 1124053, 1124707, 1124709
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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