United StatesConvatec EsteemBody Drainable Pouch REF 423643 (10–45 mm), REF 423653 (10–35 mm), and REF 423657 (10–35 mm) are affected; identifiers include UDI 00768455221264 lot 5K00011 and 5K00714, UDI 00768455221363 lot 5K01728, and UDI 00768455221400 lot 5J03908, distributed worldwide (including the U.S., Canada, UK, EU countries, Australia, China, Japan, and others). The pouches were recalled because the drainable large pouch may leak due to a manufacturing issue.
What's being recalled
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Recalling firm: ConvaTec, Inc, Greensboro, NC, United States.
How to identify it
UDI: 00768455221264 Lot: 5K00011,5K00714 UDI: 00768455221363 Lot: 5K01728 UDI: 00768455221400/ Lot: 5J03908
The hazard
Drainable large pouch may leak due to manufacturing issue.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)