Cook Incorporated: COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Cook Incorporated
- 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.
- Reason / hazard
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution.
- Recall initiated
- 2026-03-05
- Code info
- 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.
- Product quantity
- 441 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bloomington
- State
- IN
- Country
- United States
- Event id
- 98495
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