Z-1791-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2026
- Initiation Date
- March 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 104 units
Product Description
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
Reason for Recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Distribution Pattern
Worldwide distribution.
Code Information
Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261020(10)15719344X, Lot Number 15719344X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)261018(10)15714808X, Lot Number 15714808X; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834145, Lot Number 15834145; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, UDI (01)00827002565371(17)260115(10)15834147, Lot Number 15834147.