Device 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
Z-0903-2025
Product summary
- Firm
- ConvaTec, Inc
- Event
- Event 95955
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 240
- Official record key
device-enforcement:Z-0903-2025
Official wording
Reason: 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
Code information: REF/UDI-DI/Lot: 405473/00768455185399/3J03813, 405479/00768455185450/3J03814
Distribution pattern: US distribution to states of: OH, NY, IL
Derived failure modes
-
Unknown
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