FDA Enforcement
Class II
Ongoing
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Recall: Z-1775-2026
·
Reported April 15, 2026
Enforcement
- Recall Number
- Z-1775-2026
- 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-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Reason
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Code Info
UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005
Distribution
Worldwide distribution.
Quantity
15 units