FDA-Device2026-03-25Class IIPROCESSING DEFECT
ConvaTec EsteemBody Drainable Pouch recalled for potential leakage due to manufacturing defect
What this means
ConvaTec has recalled certain EsteemBody Drainable Pouches (model REF:423653, 10-35mm) because they may leak due to a manufacturing issue. The affected product has lot number 5K01728. No injuries have been reported.
- Stop using the recalled pouch if you have lot number 5K01728
- Contact ConvaTec for a replacement or refund
- If you have questions, check the product box for contact information or visit ConvaTec's website
The agency's original wording
Hazard
Drainable large pouch may leak due to manufacturing issue.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
N/A
Manufactured in
7815 National Service Rd Ste 600, N/A, Greensboro, NC, United States
Products
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1583-2026Want us to check the next one for you?
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