Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1890-2018 — Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem 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.

U.S. FDA — Device Enforcement · United States · 2018-04-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1890-2018
Date of alert: 2018-04-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ConvaTec, Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1890-2018 — Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem 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.

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