Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy syst...
FDA Recall #Z-0903-2025 — Class II — November 29, 2024
Product Description
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
Reason for Recall
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
Recalling Firm
ConvaTec, Inc — Greensboro, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
240
Distribution
US distribution to states of: OH, NY, IL
Code Information
REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated