Recall Z-1779-2026 ยท JOH Tube Tracheostomy And Tube Cuff
Cook Incorporated
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.
| Date | Apr 6, 2026 (initiated Mar 5, 2026) |
| Status | Open, Classified |
| Reason | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Root cause | Incorrect or no expiration date |
| Action | Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowled |
| Quantity | 916 units |
| Distribution | Worldwide distribution. |
| 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 |