FDA Enforcement
Class II
Ongoing
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
Recall: Z-1776-2026
·
Reported April 15, 2026
Enforcement
- Recall Number
- Z-1776-2026
- Event ID
- 98495
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- April 15, 2026
- Initiation Date
- March 5, 2026
- Classification Date
- April 6, 2026
- Address
- 750 N Daniels Way, Bloomington, IN, 47404-9120, United States
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
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Code Info
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.
Quantity
49 units