[pending] COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number
Pending LLM rewrite. Source: FDA_DEVICE Z-1776-2026.
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 Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
- 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 (8)
- Reference Part Number CMW-14-190-12G
- UDI (01)00827002507876(17)260509(10)15885574X
- Lot Number 15885574X
- UDI (01)00827002507876(17)281203(10)15783003X
- Lot Number 15783003X
- Reference Part Number CMW-14-300-12G
- UDI (01)00827002507913(17)260227(10)15416547
- Lot Number 15416547.
Distribution
Distribution scope not specified by the agency.
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