Z-1582-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 25, 2026
- Initiation Date
- February 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Reason for Recall
Drainable large pouch may leak due to manufacturing issue.
Distribution Pattern
Worldwide 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.
Code Information
UDI: 00768455221264 Lot: 5K00011,5K00714