FDA-Device2026-04-15Class IIMISBRANDING
Cook Medical Blue Rhino G2 tracheostomy introducer tray recalled for incorrect expiration dates
EXPIRATION DATE ERRORNationwide distribution
Check expiration dates on Cook Medical Blue Rhino tracheostomy kits
Cook Medical's Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray was labeled with expiration dates that are longer than the actual shelf life of the product. This affects specific lot numbers distributed worldwide. No injuries have been reported.
- Check your inventory for the affected lot numbers listed in this recall
- Do not use products beyond their true shelf life, even if the package label shows a later date
- Contact Cook Medical or your supplier for instructions on replacement or return
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Sold states
Worldwide distribution.
Affected count
441 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1780-2026More Cook Incorporated recalls
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- FDA-Device2026-04-15COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
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