Cook Incorporated: Tube Tracheostomy And Tube Cuff

Recalling firm
Cook Incorporated
Product
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.
Reason
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-03-05
Status
Open, Classified
Distribution
Worldwide distribution.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/21da9426-b710-42ff-baaa-e1f9bdca2d26