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ConvaTec, Inc: Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm

Medical DevicesSource: FDA (device) · Date: 2026-03-25

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
ConvaTec, Inc
Product
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Reason / hazard
Drainable large pouch may leak due to manufacturing issue.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-02-16
Code info
UDI: 00768455221264 Lot: 5K00011,5K00714
Product quantity
N/A
Voluntary mandated
Voluntary: Firm initiated
City
Greensboro
State
NC
Country
United States
Event id
98455
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