ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an ad…

Recall date

November 29, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0903-2025

FDA classification

Class II

Brand / firm

ConvaTec, Inc

Sold / distributed

US distribution to states of: OH, NY, IL

Why it was recalled

Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479