Reported May 17, 2023 · Ongoing
Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5…
Cook Incorporated
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- 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)
- Lot codes and dates
- 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
- Amount recalled
- 25,161 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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