FDA-Device2026-04-15Class IIMISBRANDING
Cook Medical Blue Rhino G2-Multi Tracheostomy Introducer Set recalled for incorrect expiration dates
EXPIRATION DATE ERRORNationwide distribution
Check Cook Medical tracheostomy introducer expiration dates
Cook Medical's Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set from certain lots was labeled with expiration dates longer than the actual shelf life of the device. This means some units may have degraded before their printed expiration date, potentially affecting performance when used.
- Check if you have any of the affected lot numbers listed in the recall notice
- Do not use any units from the recalled lots
- Contact Cook Medical or your supplier for replacement units or further instructions
- Verify the actual expiration date with Cook Medical if you are unsure
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Sold states
Worldwide distribution.
Affected count
916 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1779-2026More Cook Incorporated recalls
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- FDA-Device2026-04-15Cook Medical Wayne Pneumothorax Set recalled for incorrect expiration dates
- FDA-Device2026-04-15Cook Medical Blue Rhino G2 tracheostomy introducer tray recalled for incorrect expiration dates
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