FDA DevicesClass II
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Published: March 25, 2026Recall ID: Z-1582-2026Category: devicesCountry: US
Reason for Recall / Hazard
Drainable large pouch may leak due to manufacturing issue.
Product Description & Identification
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Affected Products
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Additional Source Details
| Field | Value |
|---|---|
| City | Greensboro |
| State | NC |
| Event id | 98455 |
| Address 1 | 7815 National Service Rd Ste 600 |
| Address 2 | N/A |
| Code info | UDI: 00768455221264 Lot: 5K00011,5K00714 |
| Postal code | 27409-9403 |
| Report date | 20260325 |
| Product type | Devices |
| Product quantity | N/A |
| Reason for recall | Drainable large pouch may leak due to manufacturing issue. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260216 |
| Initial firm notification | |
| Center classification date | 20260319 |
Overview
- Recalling FirmConvaTec, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Australia, Canada, China, Czech Republic, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Poland, Slovakia, Sweden, Switzerland, UK.