medical Class II Updated 2025-01-22

ConvaTec, Inc recalls Esteem Synergy Stomahesive Skin Barrier, part of Esteem syne

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: OH, NY, IL
Lot/Code Info: REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814
View official government recall

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