FDA DevicesClass II
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25...
Published: April 15, 2026Recall ID: Z-1786-2026Category: 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 Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Affected Products
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Additional Source Details
| Field | Value |
|---|---|
| City | Bloomington |
| State | IN |
| Event id | 98495 |
| Address 1 | 750 N Daniels Way |
| Code info | Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)261005(10)NS15690755, Lot Number NS15690755; Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)260426(10)NS15408335, Lot Number NS15408335. |
| Postal code | 47404-9120 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 20 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.