Volver al buscador
FDAFDA · Alimentos y medicamentos·N.º oficial Z-1428-2023

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)

Publicado el 17 de mayo de 2023 · Inicio del retiro: 7 de abril de 2023

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

Qué peligro representa

There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Cook Incorporated
Distribuidor
Worldwide distribution - US Nationwide.
Lote
C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725): UDI-DI 00827002577251, Lot Numbers 14351912, 14345668; C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720): UDI-DI 00827002577206, Lot Numbers 14210437, 14244442, 14227741, 14210440, 14244446, 14227742, 14229768, 14261042, 14270295, 14307644, 14270297, NS14266221, 14327007, 14327004, 14345700, 14351916, 14365704, 14365703, 14351915, 14385191, 14365704, 14365703; C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721): UDI-DI 00827002577213, Lot Numbers 14705461, 14244431, 14288336, 14288338, 14288337, 14288340, 14342930, 14365698, 14342928, 14365702, 14365697, 14342932, 14342926, 14446938, 14446936, 14342931, 14705460, 14288336, 14288337; C-PTISY-100-HC-G-NA-FLEX8.5 (G57717): UDI-DI 00827002577176, Lot Numbers 15065444, 15105535, 15085585, 15049864, 15065462, 15105517, 14984774, 15137049, 15065458, 15137047, 15137038, 15085578, 15137052, 15085588, 15148020, 15137043, 15085580, 15137032, 15065443, 15148022, 15137039, 15065442, 15085576, 15122458, 15026744, 15049860, 15137046, 14984768, 15065453, 15085589, 15065447, 15105529, 15122467, 15049872, 15065459, 15137041, 15137053, 15137042, 15148025, 15137030, 15137051, 15137055, 14270288, 14284554, 14284553, 14284544, 14244437, 14244429, 14210449, 14244436, 14317249, 14221185, 14293814, 14293832, 14293817, 14293830, 14293840, 14293825, 14293820, 14293822, 14293816, 14293836, 14293827, 14293845, 14293828, 14293823, 14345626, 14293818, 14345703, 14293835, 14345701, 14345652, 14345673, 14345604, 14345666, 14345609, 14293838, 14345690, 14345605, 14345588, 14345589, 14345591, 14345672, 14345688, 14345635, 14345586, 14345610, 14345705, 14345633, 14345648, 14345669, 14345671, 14345686, 14345689, 14345651, 14345600, 14345571, 14345629, 14345572, 14345631, 14345606, 14345620, 14345603, 14345632, 14345630, 14345608, 14345649, 14345650, 14345595, 14345577, 14345659, 14345573, 14317237, 14293843, 14345661, 14317231, 14345704, 14345698, 14345693, 14345575, 14317246, 14345682, 14345583, 14345598, 14317228, 14345641, 14345670, 14317205, 14345655, 14317206, 14345581, 14317219, 14345657, 14345624, 14332962, 14360178, 14360175, 14332971, 14317211, 14360155, 14360159, 14317233, 14345618, 14332982, 14360156, 14360179, 14360168, 14360153, 14360148, 14332974, 14360144, 14360145, 14317236, 14345675, 14317214, 14317218, 14317221, 14317229, 14332983, 14332980, 14360167, 14385174, 14385173, 14410932, 14332970, 14345616, 14385183, 14385195, 14410925, 14317232, 14385187, 14385180, 14360158, 14360163, 14385192, 14332981, 14360174, 14317227, 14332984, 14385190, 14317240, 14332966, 14360161, 14385186, 14385196, 14385184, 14360177, 14332972, 14360149, 14332963, 14385171, 14385170, 14385194, 14332976, 14360160, 14385188, 14385198, 14360171, 14385181, 14385197, 14360146, 14345579, 14360166, 14345696, 14317241, 14360157, 14410942, 14317247, 14360162, 14360170, 14332975, 14410928, 14317208, 14433141, 14385178, 14293846, 14410945, 14332960, 14332979, 14410929, 14410937, 14410935, 14433133, 14410943, 14410949, 14410920, 14445218, 14433159, 14433145, 14433163, 14433162, 14445233, 14445237, 14445225, 14445221, 14464001, 14445230, 14463995, 14433140, 14464002, 14464005, 14463984, 14463992, 14445229, 14445231, 14464009, 14464007, 14463989, 14445240, 14433158, 14445234, 14445220, 14433153, 14463982, 14445224, 14463994, 14614202, 14614206, 14614184, 14614183, 14614189, 14614192, 14614182, 14513800, 14614204, 14614191, 14614190, 14614205, 14614200, 14614196, 14614188, 14614199, 14586755, 14614187, 14445242, 14445232, 14445219, 14464003, 14445239, 14463981, 14485880, 14563148, 14614194, 14643690, 14614201, 14643669, 14643668, 14643694, 14643673, 14643676, 14643670, 14643692, 14643672, 14485905, 14643687, 14679258, 14643685, 14679251, 14679271, 14643679, 14643693, 14643680, 14679260, 14563144, 14643675, 14643689, 14643681, 14643683, 14679250, 14643695, 14679259, 14679264, 14614207, 14643684, 14586751, 14643678, 14643682, 14679269, 14679265, 14679263, 14679253, 14679247, 14679267, 14679255, 14679270, 14679248, 14679261,
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta