Reported Nov 2, 2022 · Ongoing

ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma…

ConvaTec, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ConvaTec, Inc · 7815 National Service Rd Ste 600 · Greensboro, NC · 27409-9403

Is this the product you have?

  • ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.
Lot codes and dates
  • UDI/DI768455115358
  • Batch Numbers
    • 2A00585
    • 2A00586
    • 2A04528
    • 2A04529
    • 2A04530m
Amount recalled
5284 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

impaired functionality of the release liner

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.