Recall Weekly
Moderate riskFDA DeviceClass II

ConvaTec EsteemBody drainable pouch recalled for possible leaks

ConvaTec's EsteemBody Drainable Pouch (model REF:423643, 10–45mm) may leak because of a manufacturing issue. The affected pouches have lot numbers 5K00011 or 5K00714 and have been distributed worldwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. Check your pouch for lot number 5K00011 or 5K00714 on the packaging.
  2. Stop using the pouch if it matches the recalled lot numbers.
  3. Contact ConvaTec or your healthcare provider for a replacement or instructions.
  4. Report any leakage or injuries to the FDA at SafetyReporting.HHS.gov.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
N/A
Illnesses reported
None reported
Manufactured in
7815 National Service Rd Ste 600, N/A, Greensboro, NC, United States
Classification
Class II
Recall number
Z-1582-2026

In the FDA's words

Description
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
Hazard
Drainable large pouch may leak due to manufacturing issue.

3 products in this recall

The agency lists each product separately. Check every one you might have.

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