Z-1776-2026 Class II Ongoing

Recalled by Cook Incorporated — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
April 15, 2026
Initiation Date
March 5, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49 units

Product Description

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

Reason for Recall

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

Distribution Pattern

Worldwide distribution.

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.