FDA-Device2026-04-15Class IIMISBRANDING
Cook Medical Ciaglia Blue Rhino tracheostomy introducer set recalled for incorrect expiration dating
What this means
Cook Medical's Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set in certain lots has been labeled with expiration dates that extend beyond the actual shelf life of the product. This affects 484 units distributed worldwide. No injuries have been reported.
- If you use or store this device, verify the lot number against the FDA recall list
- Do not use products beyond their true shelf life, regardless of the label date
- Contact your supplier or Cook Medical for guidance on affected units
The agency's original wording
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution.
Affected count
484 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2026Want us to check the next one for you?
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