[pending] COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G565
Pending LLM rewrite. Source: FDA_DEVICE Z-1791-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
The recalled product
- Product
- COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH
- UDI (01)00827002565371(17)261020(10)15719344X
- Lot Number 15719344X
- UDI (01)00827002565371(17)261018(10)15714808X
- Lot Number 15714808X
- UDI (01)00827002565371(17)260115(10)15834145
- Lot Number 15834145
- UDI (01)00827002565371(17)260115(10)15834147
- Lot Number 15834147.
Distribution
Distribution scope not specified by the agency.
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