FDA Enforcement
Class II
Ongoing
COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Recall: Z-1782-2026
·
Reported April 15, 2026
Enforcement
- Recall Number
- Z-1782-2026
- 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 Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Reason
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Code Info
Reference Part Number C-CAE-14.0-83-EXTU, UDI (01)00827002240735(17)270509(10)16010654, Lot Number 16010654.
Distribution
Worldwide distribution.
Quantity
95 units