FDAClass IMay 17, 2023

Blue Rhino G2-Multi Percutaneous Tracheostomy recall

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725)…

Why was Blue Rhino G2-Multi Percutaneous Tracheostomy recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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, 14679257, 14679256, 14679254, 14679268, 14545381, 14485900, 14643691, 14513821, 14586778, 14643677, 14679249, 14727200, 14727184, 14727201, 14727202, 14679252, 14727193, 14750617, 14750612, 14750601, 14750598, 14750624, 14750614, 14750603, 14750622, 14750615, 14614203, 14727204, 14750620, 14750611, 14750602, 14614195, 14750605, 14750616, 14750608, 14727190, 14727203, 14727208, 14727185, 14727188, 14727205, 14727186, 14727196, 14727189, 14727194, 14727183, 14772864, 14772866, 14772883, 14772876, 14772869, 14772884, 14772879, 14772862, 14772888, 14772887, 14772870, 14727191, 14772874, 14772881, 14772875, 14772886, 14772878, 14772871, 14772877, 14772882, 14772865, 14727195, 14750613, 14750621, 14643674, 14772873, 14772867, 14643671, 14772863, 14825708, 14825709, 14801168, 14801163, 14801182, 14801175, 14825717, 14801161, 14825712, 14801178, 14825725, 14801181, 14801177, 14825715, 14825710, 14801171, 14801164, 14825720, 14801179, 14801172, 14825723, 14825707, 14801173, 14801166, 14801167, 14825703, 14801176, 14801165, 14825716, 14801169, 14801184, 14801170, 14825719, 14801160, 14801180, 14727206, 14727198, 14614185, 14614193, 14360147, 14614186, 14874492, 14874502, 14874494, 14847410, 14727199, 14847403, 14727209, 14772872, 14614198, 14801162, 14801183, 14643667, 14614197, 14940475, 14911513, 14911506, 14961724, 14911509, 14874500, 14911504, 14911519, 14911515, 14911511, 14940484, 14874498, 14940474, 14911508, 14911512, 14911510, 14911523, 14961715, 14874499, 14874504, 14847407, 14911516, 14961720, 14961722, 14874510, 14874513, 14874515, 14961719, 14961735, 14961738, 14911505, 14940469, 14911529, 14961737, 14847417, 14874508, 14961741, 14874488, 14874493, 14911522, 14911507, 14825718, 14940490, 14874505, 14874495, 14940477, 14961734, 14874511, 14940466, 14911527, 14911521, 14940472, 14874485, 14874490, 14961730, 14961717, 14911520, 14961718, 14911518, 14874506, 14961729, 14874503, 14911514, 14874516, 14961727, 14911517, 14911528, 14874501, 14874509, 14940483, 14940476, 14940489, 14940468, 14940480, 14940473, 14874507, 14874487, 14984765, 14984770, 15105521, 15026745, 15049870, 14984771, 15049875, 15085571, 15026752, 15049866, 15105522, 15049867, 15065449, 15105531, 15049878, 15049877, 15085570, 14984757, 14984780, 15049881, 15026753, 15065446, 15065448, 15065460, 15065455, 15065456, 15105527, 14984766, 15026749, 15085574, 15026759, 15065440, 15049862, 15105532, 15049861, 15049874, 15085568, 15049868, 15065452, 15065463, 15065441, 15105524, 15085577, 15105520, 15105534, 15049871, 15085584, 15105518, 15049876X, 15105533, 15105514, 14984761, 15065457, 14984773, 15049880, 14984769, 15049865, 15049869, 15105536, 15105528, 15122454, 14984764, 15049879, 15065445, 15085575, 15085582, 15122464, 15049863, 15105525, 14984767, 15085586, 15105526, 15137044, 15105513, 15065439, 15085567, 15065461, 15085569, 15085573, 15105519, 15085572, 15085581, 15049873, 14293830, 14345633; C-PTISY-100-HC-G-NA-FLEX7.5 (G57716): UDI-DI 00827002577169, Lot Numbers 15032438, 15154065, 15131208, 15141529, 15141530, 15141531, 15032434, 15060623, 14976871, 15131202, 15154063, 15154064, 15154062, 15141528, 14266217XXXX, 14266217XX, 14266217XXX, 14210447, 14221195, 14221166, 14221179, 14229746, 14221147, 14229749, 14188157, 14221116, 14221199, 14221207, 14221130, 14221137, 14182980, 14258282, 14229748, 14174839, 14229767, 14258284, 14221189, 14229766, 14198605, 14221148, 14210454, 14229774, 14229759, 14258278, 14188161, 14258277, 14221124, 14165623, 14229750, 14258280, 14229753, 14229764, 14258285, 14221120, 14174840, 14221156, 14284555, 14229757, 14244424, 14244453, 14244460, 14284550, 14284560, 14244449, 14266213, 14284548, 14266210, 14266212, 14284565, 14266211, 14266218, 14244423, 14221142, 14258279, 14266209, 14266219, 14284561, 14221136, 14221155, 14244428, 14244457, 14284563, 14284556, 14244426, 14284558, 14266220, 14293844, 14293839, 14345660, 14293829, 14345683, 14345580, 14345644, 14345597, 14345680, 14345601, 14345599, 14345697, 14345658, 14345647, 14345640, 14345617, 14345619, 14345622, 14345596, 14345663, 14345642, 14345678, 14345656, 14345695, 14345677, 14345694, 14345639, 14293821, 14345576, 14345578, 14293824, 14339446, 14345664, 14345699, 14345614, 14345621, 14317209, 14345623, 14293833, 14345602, 14345582, 14345645, 14345662, 14339448, 14345654, 14345684, 14327006, 14317230, 14327002, 14351899, 14339443, 14345625, 14317234, 14317242, 14327003, 14326999, 14351898, 14293826, 14317207, 14373852, 14398117, 14317248, 14327005, 14293815, 14351905, 14373857, 14398097, 14398114, 14398103, 14398111, 14351906, 14293837, 14351919, 14351900, 14326998, 14327001, 14351901, 14373862, 14373854, 14373849, 14339445, 14398119, 14373863, 14293841, 14351907, 14345681, 14339447, 14351896, 14317223, 14351921, 14398107, 14398105, 14520947, 14589758, 14520950, 14589763, 14589762, 14559684, 14589757, 14542266, 14589759, 14619989, 14559683, 14619981, 14619980, 14439428, 14456427, 14473242, 14439438, 14473241, 14473238, 14619975, 14619979, 14542263, 14657237, 14619985, 14542262, 14657236, 14657234, 14657238, 14711700, 14711703, 14758764, 14758762, 14758765, 14711705, 14758759, 14758763, 14788103, 14788106, 14788105, 14788104, 14788102, 14788101, 14820627, 14820628, 14820623, 14820626, 14820630, 14820629, 14871757, 14871753, 14871756, 14871755, 14896942, 14896940, 14871754, 14896943, 14896939, 14926507, 14926504, 14926502, 14950574, 14950571, 14950570, 14926503, 14926508, 14950573, 14950569, 14976873, 14926499, 14896941, 14976877, 14976874, 14976875, 15032436, 15032435, 15032437, 15060624, 15060621, 15060625, 15060622, 15083749, 15083744, 15083747, 15083746, 15083745, 14559685, 15131203, 15131205, 14229757, 15141529

Product
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725)…
Recalling firm
Cook Incorporated
Quantity
25,161 units
Distribution
Worldwide distribution - US Nationwide.
Recall date
May 17, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls