Device product

Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm

Z-1583-2026

February 16, 2026

Class II

Product summary

Firm: ConvaTec, Inc
Event: Event 98455
Status: Ongoing
Classification: Class II
Quantity: N/A
Official record key: device-enforcement:Z-1583-2026

Official wording

Reason: Drainable large pouch may leak due to manufacturing issue.

Code information: UDI: 00768455221363 Lot: 5K01728

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
reason.no_named_rule · v1.0.0

Drainable large pouch may leak due to manufacturing issue.