Device 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

Z-1776-2026

March 05, 2026

Class II

Product summary

Firm: Cook Incorporated
Event: Event 98495
Status: Ongoing
Classification: Class II
Quantity: 49 units
Official record key: device-enforcement:Z-1776-2026

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 CMW-14-190-12G, UDI (01)00827002507876(17)260509(10)15885574X, Lot Number 15885574X; Reference Part Number CMW-14-190-12G, 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 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.