Recalling firm
ConvaTec, Inc
Product type
Device
Status
Ongoing
Report date
2026-03-25
Distribution
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.
Firm state
NC
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
Drainable large pouch may leak due to manufacturing issue.
Product description
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Code / lot info
UDI: 00768455221264 Lot: 5K00011,5K00714
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.