FDA-Device2026-04-15Class II

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

Cook Incorporated

Hazard

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

Sold states

Worldwide distribution.

Affected count

49 units

Manufactured in

750 N Daniels Way, Bloomington, IN, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1776-2026

Original summary

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 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. 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: Worldwide distribution. Affected quantity: 49 units

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