Device product

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.

Z-1780-2026

March 05, 2026

Class II

Product summary

Firm: Cook Incorporated
Event: Event 98495
Status: Ongoing
Classification: Class II
Quantity: 441 units
Official record key: device-enforcement:Z-1780-2026

Official wording

Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Code information: 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 pattern: Worldwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.