ConvaTec, Inc: 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 WHT16/35

Hazard

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

Details from the source

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 Distribution: US distribution to states of: OH, NY, IL Quantity: 240 Lot/code info: REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814

UPC codes

00768455185399, 00768455185450

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.