Recall Z-1428-2023 ยท JOH Tube Tracheostomy And Tube Cuff
Cook Incorporated
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)
| Date | May 10, 2023 (initiated Apr 7, 2023) |
| Status | Open, Classified |
| 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 fo |
| Quantity | 25,161 units |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193133 | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer T Cook Incorporated, Dec 12, 2019 |