FDA-Device2026-03-25Class II
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
ConvaTec, Inc
Hazard
Drainable large pouch may leak due to manufacturing issue.
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:423643, 10-45mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1582-2026Original summary
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm Drainable large pouch may leak due to manufacturing issue. UDI: 00768455221264 Lot: 5K00011,5K00714 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. Affected quantity: N/A
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