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Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-H...

FDA Recall #Z-1427-2023 — Class I — April 7, 2023

Recall #Z-1427-2023 Date: April 7, 2023 Classification: Class I Status: Ongoing

Product Description

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)

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.

Recalling Firm

Cook Incorporated — Bloomington, IN

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

3.053 units

Distribution

Worldwide distribution - US Nationwide.

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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