FDAFDA · Alimentos y medicamentos·N.º oficial Z-1836-2015
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Publicado el 1 de julio de 2015 · Inicio del retiro: 1 de junio de 2015
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
Stryker Sustainability Solutions is recalling Trocars because they have received reports indicating that some may fracture at the distal tip resulting in fragments at the surgical site.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Stryker Sustainability Solutions
- Distribuidor
- Distributed Nationwide including Puerto Rico.
- Lote
- Lot Codes for Model CTS02: 362394, 420607, 428114, 429863, 459230, 459592, 459597, 459960, 459990, 461060, 461694, 465212, 466767, 467172, 468490, 469533, 469538, 469539, 469540, 469955, 469956, 469963, 470140, 470614, 471021, 471067, 471079, 471092, 471102, 471109, 471126, 471131, 471135, 471895, 472125, 473040, 473260, 473293, 474004, 474015, 474035, 474324, 474338, 474340, 474476, 475171, 475465, 475617, 476151, 476173, 476200, 476259, 476272, 476277, 476989, 477306, 477315, 478318, 478338, 478339 478668, 479821, 479828, 480663, 480677, 480682, 480684, 481607, 481808, 481951, 481960, 481968, 483554, 483918, 483922, 483926, 483953, 483963 484011, 484027, 484032, 485218, 485511, 485557, 485567, 485591, 485622, 485656, 485660, 486107, 486138, 486143, 486209, 486253, 486800, 487210, 489255, 489651, 489704, 489738, 489745, 489957, 489958, 489962, 489979, 490076, 490086, 490864, 491163, 491256, 600325, 600929, 601012, 601925, 601982, 603277, 609051, 1786420, 1825271, 1891296, 2027905, 2163528, 2171826, 2175866, 2208579, 2222389, 2271560, 2279303, 2315316, 2954381, 2954628, 2954637, 2954778, 2957110, 2957134, 2958233, 2958246, 2969207, 2969426, 2969662, 2971689, 2972095, 2973798, 2974887, 2975148, 2975549, 2978669, 2978885, 2978892, 2980457, 2980834, 2983706, 2984021, 2984032, 2987284, 2987526, 2987896, 2989769, 2991263, 2993610, 2994626, 2995924, 2999738, 3002060, 3005909, 3018096, 3018650, 3020166, 3020757, 3021385, 3024073, 3026984, 3028690, 3028730, 3031396, 3031995, 3034204, 3037138, 3039352, 3040004, 3042988, 3043284, 3047352, 3047368, 3052859, 3054151, 3056633, 3056646, 3058219, 3059896, 3061761, 3065444, 3067448, 3070389, 3070391, 3072732, 3072745, 3075949, 3078655, 3081506, 3082044, 3083550, 3083597, 3085192, 3086485, 3086492, 3089009, 3091458, 3093279, 3096393, 3099949, 3184750, 3185474, 3186015, 3187181, 3187989, 3190002, 3190820, 3192550, 3193913, 3195683, 3198508, 3200845, 3201425, 3203415, 3204394, 3206304, 3207173, 3209437, 3210285, 3212965, 3214734, 3215952, 3217550, 3222005, 3224973, 3226077, 3231623, 3232298, 3234278, 3235296, 3286925, 3287266, 3290012, 3291855, 3291864 Lot Codes for Model CTS22: 362394, 365226, 419887, 429863, 459960, 469533, 469538, 469539, 469540, 471038, 471895, 472125, 475171, 476259, 481709, 481951, 481965, 481971, 483578, 483963, 484002, 484032, 485506, 486148, 486800, 487212, 487954, 489255, 489957, 490153, 603981, 1742132, 2171826, 2271563, 2295535, 3180274, 3180699, 3180702, 3185379, 3187970, 3190574, 3193160, 3195339, 3200866, 3209060, 3212544, 3215947, 3218572, 3221995, 3225575, 3226065, 3233621, 3288568, 3288575
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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