FDA Enforcement
Class II
Ongoing
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Recall: Z-1790-2026
·
Reported April 15, 2026
Enforcement
- Recall Number
- Z-1790-2026
- 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 Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Reason
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Code Info
Reference Part Number C-TQTSY-3200, UDI (01)00827002072428(17)270221(10)NS15796862X, Lot Number NS15796862X; Reference Part Number C-TQTSY-3200, UDI (01)00827002072428(17)270301(10)NS15881832X, Lot Number NS15881832X.
Distribution
Worldwide distribution.
Quantity
2 units