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FDAFDA · Alimentos y medicamentos·N.º oficial Z-1726-2019

Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.

Publicado el 12 de junio de 2019 · Inicio del retiro: 7 de marzo de 2019

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 heated tube sets were consistently leaking and detaching from the cassette.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Stryker Corporation
Distribuidor
Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Uruguay.
Lote
UDI - 07613327055634 Lot numbers: 18G0269, 18H0353, 18K0379 , 56004320, 56004325, 56004329, 56004356, 56004366, 56004373, 56004384, 56004387, 56004426, 56004432, 56004441, 56004443, 56004451, 56004459, 56004461, 56004487, 56004494, 56004502, 56004508, 56004515, 56004518, 56004528, 56004551, 56004565, 56004573, 56004584, 56004600, 56004614, 56004616, 56004624, 56004628, 56004632, 56004681, 56004686, 56004696, 56004704, 56004719, 56004721, 56004735, 56004737, 56004739, 56004748, 56004750, 56004760, 56004771, 56004791, 56004795, 56004809, 56004811, 56004816, 56004818, 56004820, 56004822, 56004826, 56004830, 56004842, 56004844, 56004846, 56004852, 56004881, 56004909, 56004913, 56004919, 56004925, 56004927, 56004929, 56004938, 56004950, 56004955, 56004957, 56004959, 56004970, 56004974, 56004976, 56004995, 56005003, 56005016, 56005018, 56005020, 56005097, 56005099, 56005104, 56005108, 56005128, 56005130, 56005132, 56005139, 56005198, 56005200, 56005206, 56005212, 56005229, 56005232, 56005246, 56005251, 56005267, 56005295, 56005297, 56005301, 56005323, 56005331, 56005339, 56005341, 56005343, 56005351, 56005353, 56005357, 56005360, 56005370, 56005372, 56005374, 56005426, 56005428, 56005440, 56005480, 56005484, 56005486, 56005504, 56005506, 56005508, 56005532, 56005534, 56005544, 56005555, 56005557, 56005588, 56005590, 56005599, 56005613, 56005615, 56005628, 56005631, 56005637, 56005640, 56005642, 56005671, 56005673, 56005686, 56005688, 56005694, 56005697, 56005710, 56005714, 56005717, 56005719, 56005728, 56005730, 56005732, 56005734, 56005749, 56005751, 56005753, 56005763, 56005765, 56005769, 56005772, 56005779, 56005812, 56005827, 56005833, 56005835, 56005837, 56005839, 56005850, 56005852, 56005858, 56005862, 56005874, 56005876, 56005895, 56005897, 56005913, 56005915, 56005933, 56005935, 56005950, 56005954, 56005965, 56005972, 56005974, 56005987, 56006156, 56006191, 56006201, 56006212, 56006216, 56006222, 56006224, 56006235, 56006249, 56006251, 56006268, 56006309, 56006311, 56006313, 56006321, 56006323, 56006325, 56006332, 56006334, 56006346, 56006348, 56006368, 56006372, 56006374, 56006378, 56006411, 56006413, 56006415, 56006430, 56006432, 56006454, 56006471, 56006473, 56006475, 56006491, 56006493, 56006495, 56006497, 56006501, 56006503, 56006506, 56006508, 56006510, 56006512, 56006542, 56006549, 56006554, 56006613, 56006633, 56006637, 56006540.
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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