FDA (Devices) recall action 98455
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Drainable large pouch may leak due to manufacturing issue.
The agency’s own wording, quoted from the enforcement report.
ConvaTec is recalling two lots of the EsteemBody Drainable Pouch, REF 423643, because the drainable large pouch may leak due to a manufacturing issue.
ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423657, because the drainable large pouch may leak due to a manufacturing issue.
ConvaTec is recalling one lot of the EsteemBody Drainable Pouch, REF 423653, because the drainable large pouch may leak due to a manufacturing issue.