Device product
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Z-1582-2026
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 98455
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1582-2026
Official wording
Reason: Drainable large pouch may leak due to manufacturing issue.
Code information: UDI: 00768455221264 Lot: 5K00011,5K00714
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.
Derived failure modes
-
Unknown
Drainable large pouch may leak due to manufacturing issue.