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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0478-2025

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

Publicado el 27 de noviembre de 2024 · Inicio del retiro: 4 de octubre de 2024

Estado reportado al momento de publicación: Completed — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Caire, Inc.
Distribuidor
Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.
Lote
UDI-DI: M766AS20010; Serial numbers: CBB5224380296, CBB5224380292, CBB5224380285, CBB5224380284, CBB5224380283, CBB5224380281, CBB5224380279, CBB5224380278, CBB5224380277, CBB5224380276, CBB5224380273, CBB5224380271, CBB5224380270, CBB5224380268, CBB5224380267, CBB5224380266, CBB5224380264, CBB5224380263, CBB5224380262, CBB5224380257, CBB5224380256, CBB5224380250, CBB5224380248, CBB5224380246, CBB5224380245, CBB5224380244, CBB5224380063, CBB5224380062, CBB5224380061, CBB5224380059, CBB5224380058, CBB5224380057, CBB5224380056, CBB5224380053, CBB5224380052, CBB5224380051, CBB5224380050, CBB5224380049, CBB5224380048, CBB5224380047, CBB5224380046, CBB5224380044, CBB5224380043, CBB5224380042, CBB5224380041, CBB5224380040, CBB5224380039, CBB5224380038, CBB5224380037, CBB5224380036, CBB5224380035, CBB5224380034, CBB5224380033, CBB5224380032, CBB5224380031, CBB5224380030, CBB5224380029, CBB5224380028, CBB5224380027, CBB5224380026, CBB5224380025, CBB5224380023, CBB5224380022, CBB5224380021, CBB5224380020, CBB5224380019, CBB5224380018, CBB5224380017, CBB5224380016, CBB5224380015, CBB5224380014, CBB5224380013, CBB5224380012, CBB5224380006, CBB5224380005, CBB5224380004, CBB5224380002, CBB5224370690, CBB5224370689, CBB5224370688, CBB5224370687, CBB5224370686, CBB5224370685, CBB5224370684, CBB5224370683, CBB5224370682, CBB5224370681, CBB5224370677, CBB5224370676, CBB5224370675, CBB5224370674, CBB5224370673, CBB5224370672, CBB5224370671, CBB5224370670, CBB5224370669, CBB5224370667, CBB5224370666, CBB5224370665, CBB5224370664, CBB5224370662, CBB5224370661, CBB5224370660, CBB5224370659, CBB5224370658, CBB5224370657, CBB5224370656, CBB5224370655, CBB5224370654, CBB5224370652, CBB5224370649, CBB5224370648, CBB5224370647, CBB5224370646, CBB5224370640, CBB5224370639, CBB5224370638, CBB5224370637, CBB5224370636, CBB5224370635, CBB5224370634, CBB5224370633, CBB5224370615, CBB5224370614, CBB5224370613, CBB5224370612, CBB5224370611, CBB5224370610, CBB5224370609, CBB5224370608, CBB5224370607, CBB5224370606, CBB5224370605, CBB5224370604, CBB5224370602, CBB5224370601, CBB5224370600, CBB5224370597, CBB5224370596, CBB5224370595, CBB5224370594, CBB5224370593, CBB5224370592, CBB5224370591, CBB5224370590, CBB5224370589, CBB5224370588, CBB5224370587, CBB5224370586, CBB5224370585, CBB5224370584, CBB5224370583, CBB5224370582, CBB5224370581, CBB5224370580, CBB5224370579, CBB5224370578, CBB5224370577, CBB5224370576, CBB5224370575, CBB5224370574, CBB5224370573, CBB5224370572, CBB5224370571, CBB5224370570, CBB5224370569, CBB5224370568, CBB5224370567, CBB5224370566, CBB5224370565, CBB5224370564, CBB5224370563, CBB5224370562, CBB5224370561, CBB5224370560, CBB5224370559, CBB5224370558, CBB5224370557, CBB5224370556, CBB5224370555, CBB5224370554, CBB5224370553, CBB5224370552, CBB5224370551, CBB5224370550, CBB5224370548, CBB5224370547, CBB5224370546, CBB5224370545, CBB5224370544, CBB5224370542, CBB5224370541, CBB5224370540, CBB5224370539, CBB5224370538, CBB5224370537, CBB5224370536, CBB5224370535, CBB5224370534, CBB5224370533, CBB5224370532, CBB5224370531, CBB5224370530, CBB5224370529, CBB5224370528, CBB5224370527, CBB5224370525, CBB5224370524, CBB5224370523, CBB5224370522, CBB5224370521, CBB5224370520, CBB5224370519, CBB5224370518, CBB5224370517, CBB5224370516, CBB5224370515, CBB5224370514, CBB5224370513, CBB5224370512, CBB5224370511, CBB5224370510, CBB5224370509, CBB5224370508, CBB5224370507, CBB5224370506, CBB5224370504, CBB5224370503, CBB5224370502, CBB5224370501, CBB5224370500, CBB5224370499, CBB5224370498, CBB5224370496, CBB5224370494, CBB5224370492, CBB5224370491, CBB5224370490, CBB5224370488, CBB5224370487, CBB5224370486, CBB5224370485, CBB5224370484, CBB5224370483, CBB5224370482, CBB5224370481, CBB5224370480, CBB5224370479, CBB5224370478, CBB5224370476, CBB5224370475, CBB5224370474, CBB5224370473, CBB5224370472, CBB5224370471, CBB5224370468, CBB5224370467, CBB5224370466, CBB5224370463, CBB5224370462, CBB5224370461, CBB5224370460, CBB5224370456, CBB5224370455, CBB
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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