Cook Incorporated: Tube Tracheostomy And Tube Cuff

Recalling firm
Cook Incorporated
Product
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
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/30dd1139-5171-49c7-9629-cb518f71a247