Use caution Medical device recall · FDA · Published April 7, 2023

Cook Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray Recall: Unsecure

Cook recalls Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays with reference part numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 and others due to unsecure connections that could lead to disconnection during use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1428-2023Medical device Cook ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmCook Incorporated750 N Daniels Way · Bloomington, IN 47404-9120

✎ GovInfoNow plain-language explainer

Cook is recalling specific models of Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays because they may not connect securely with 15mm circuit components, risking disconnection during medical procedures. This could lead to complications for patients needing tracheostomy care. Read more at govinfonow.com/recall/58595-cook-blue-rhino-g2-multi-percutaneous-tracheostomy-introducer-tray-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/58595-cook-blue-rhino-g2-multi-percutaneous-tracheostomy-introducer-tray-recall · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1428-2023

Cite this page

“Cook Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray Recall: Unsecure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/58595-cook-blue-rhino-g2-multi-percutaneous-tracheostomy-introducer-tray-recall. Based on FDA recall #Z-1428-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1428-2023%22&limit=1).

The Food and Drug Administration announced on April 7, 2023, that Cook Incorporated is recalling Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Trays due to a hazard involving unsecure connections. The FDA said the tracheostomy in the sets and trays may not make a secure connection with 15mm cap and other components.

How to tell if you have it

Brand: Cook
Product: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray
Reference Part Numbers: C-PTISYJ-100-HC-G-EU-FLEX8.5, C-PTISYJ-100-HC-G-NA-FLEX7.5, C-PTISYJ-100-HC-G-NA-FLEX8.5, C-PTISY-100-HC-G-NA-FLEX8.5, C-PTISY-100-HC-G-NA-FLEX7.5
Units affected: 25,161

The hazard

Context

GovInfoNow's records show Cook Incorporated has 15 other recalls on record since May 5, 2022. Other recent recalls of similar products include Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026), Wilson-Cook Teslatome Sphincterotomes Recall (December 18, 2025), and AVID Medical Halyard CARDIAC CATH TRAY SHANDS JAX Kit Recall (March 13, 2026).

How to tell if you have this one

Check for reference part numbers C-PTISYJ-100-HC-G-EU-FLEX8.5, C-PTISYJ-100-HC-G-NA-FLEX7.5, C-PTISYJ-100-HC-G-NA-FLEX8.5, C-PTISY-100-HC-G-NA-FLEX8.5, or C-PTISY-100-HC-G-NA-FLEX7.5. Also look for specific lot numbers and UDI-DI codes listed in the recall notice.

Brand
Cook
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class I
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide.

Recall number	Product, codes & lots	Quantity
Z-1427-2023	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); 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	3.053 units
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); 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	25,161 units

Based on the official FDA remedy

What to do — step by step

Check for Unsecure Connections
Inspect the tray for loose connections with 15mm circuit components, caps, or accessories. If connections are loose, stop using the tray immediately.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 40 days after the firm started it.

Apr 7, 2023Firm started the recall
May 10, 2023FDA classified it Class I
May 17, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/58595-cook-blue-rhino-g2-multi-percutaneous-tracheostomy-introducer-tray-recall">Cook Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray Recall: Unsecure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1428-2023 (April 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1428-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.