ConvaTec, Inc: Device Recall
Recall #Z-0903-2025 · 11/29/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0903-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- ConvaTec, Inc
- Status
- Ongoing
- Date Initiated
- 11/29/2024
- Location
- Greensboro, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240
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
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
Distribution Pattern
US distribution to states of: OH, NY, IL
Other Recalls by ConvaTec, Inc
- Class II: Risk 08/29/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.