Reported May 23, 2018 · Terminated

Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with…

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 · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076

Is this the product you have?

  • Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm
  • REF 405475 Product UsageEsteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output
Lot codes and dates
  • Lot Number 7F00987
Amount recalled
200 boxes of 10

Where it was sold

  • Nationwide

Why it was recalled

It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 27, 2023 · Data as of Sep 19, 6:16 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.