ConvaTec EsteemBody Drainable Pouch Recall for Leaking Issue, 847 Units

ConvaTec initiated a Class II recall for its EsteemBody Drainable Pouch (REF:423643, 10-45mm) due to a manufacturing issue that may cause the drainable large pouch to leak. The recall affects 847 units distributed worldwide including US Nationwide and countries such as Australia, Canada, China, Germany, and Italy. FDA classified this as a Class II recall, indicating temporary or reversible health consequences are possible.\n\nHealthcare providers and patients using these pouches should identify affected units by reference number and discontinue use. Distributors should cease distribution and coordinate returns with ConvaTec. Adverse events potentially related to this device should be reported to FDA MedWatch.