FDA DevicesClass II
COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IM...
Published: April 15, 2026Recall ID: Z-1791-2026Category: devicesCountry: US
Reason for Recall / Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Bloomington |
| State | IN |
| Event id | 98495 |
| Address 1 | 750 N Daniels Way |
| Code info | 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. |
| Postal code | 47404-9120 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 104 units |
| Reason for recall | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260305 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260406 |
Overview
- Recalling FirmCook Incorporated
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution.