FDA-Device2026-04-15Class II

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.

Cook Incorporated
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-1780-2026

Original summary

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. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270730(10)16183353X, Lot Number 16183353X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270524(10)16076948, Lot Number 16076948; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260222(10)15473203X, Lot Number 15473203X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260201(10)15476984X, Lot Number 15476984X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)261020(10)15719188X, Lot Number 15719188X; Reference Part Number C-PTISY-100-UNL-HC-G-NA, UDI (01)00827002577060(17)270814(10)16205108, Lot Number 16205108; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270528(10)16080161X, Lot Number 16080161X; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270901(10)16435112, Lot Number 16435112. Distribution: Worldwide distribution. Affected quantity: 441 units

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