Exact FDA event identifier

Event 92083

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 07, 2023
Product types: Device
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: Cook Incorporated

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)

Z-1427-2023

Recall number: Z-1427-2023
Initiated: April 07, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Cook Incorporated
Quantity: 3.053 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

C-PTIS-100-HC-G-EU-FLEX7.5 (G57695): UDI-DI 00827002576957, Lot Number 14842940; C-PTIS-100-HC-G-EU-FLEX8.5 (G57696): UDI-DI 00827002576964, Lot Numbers 14727192, 14332964, 14335896, 14380758, 14380755, 14332978, 14332973, 14335892, 14335893, 14464000, 14332985, 14464008, 14463988, 14503228, 14503224, 14503222, 14503229, 14503227, 14742869, 14742870, 14727207, 14742873; C-PTIS-100-HC-G-NA-FLEX7.5 (G57691): UDI-DI 00827002576919, Lot Numbers 15063922, 15063923, 15103482, 14227740, 14221180, 14204927, 14227743, 14221125, 14221198, 14221190, 14163328, 14250265, 14250269, 14317245, 14317213, 14345634, 14376893, 14633088, 14633089, 14794549, 14794548, 14794547, 14874486, 14874484, 14926500, 14967737, 14926505, 14967739, 14967741, 14221180; C-PTIS-100-HC-G-NA-FLEX8.5 (G57692): UDI-DI 00827002576926, Lot Numbers 14608362, 14750607, 14894816, 14264399, 14299799, 14299802, 14299803, 14345667, 14365693, 14365699, 14365696, 14365694, 14365701, 14345687, 14345587, 14456438, 14456443, 14456431, 14407846, 14750610, 14488394, 14488418, 14608361, 14608363, 14750618, 14608360, 14961742, 14961716, 15089037, 15089038, 15136113

Distribution pattern

Worldwide distribution - US Nationwide.

device · product 2 of 2

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)

Z-1428-2023

Recall number: Z-1428-2023
Initiated: April 07, 2023
Classification: Class I
Status: Ongoing
Recalling firm: Cook Incorporated
Quantity: 25,161 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide.