FDA Enforcement
Class II
Ongoing
COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Recall: Z-1777-2026
·
Reported April 15, 2026
Enforcement
- Recall Number
- Z-1777-2026
- 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-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
Reason
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Code Info
Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)290214(10)15898546X, Lot Number 15898546X; Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)270115(10)15660224, Lot Number 15660224; Reference Part Number CMW-14-300-18G, UDI (01)00827002507920(17)260718(10)15220204, Lot Number 15220204.
Distribution
Worldwide distribution.
Quantity
75 units