Cook Incorporated: 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)

Recall number

Z-1427-2023

Recalling firm

Cook Incorporated

Product

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)

Status

Open, Classified

Initiated

2023-04-07

Posted

2023-05-10

Terminated

not on file

Reason

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.

Root cause

Nonconforming Material/Component

Action

An URGENT: MEDICAL DEVICE RECALL dated 4/7/23 was sent to customers. Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Sets and Trays from the Cook Medical lots in Attachment A. If so, quarantine any affected sets/trays that remain unused. Immediately cease all further distribution and use of the affected sets/trays. 2. Return the complete sets/trays to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected sets/trays on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected sets/trays have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. Action being Taken by Cook Medical Cook Medical is removing potentially affected products from the market and replacing potentially defective tracheostomy tubes with new tracheostomy tubes as they become available from Medtronic. We recognize that this situation is a potential disruption to your normal operations, and we sincerely apologize. Thank you for your immediate assistance in this matter. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. We look forward to your return of the Acknowledgement and Receipt Form.

Quantity

3.053 units

Distribution

Worldwide distribution - US Nationwide.

Lot, serial or model codes

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

510(k) numbers

["K193133"]

PMA numbers

not on file

Product code

JOH

Firm FEI

1820334

Firm city

Bloomington

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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