Reported Jan 22, 2025 · Ongoing
Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an…
ConvaTec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConvaTec, Inc · 7815 National Service Rd Ste 600 · Greensboro, NC · 27409-9403
Is this the product you have?
- 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 pouchESTEEM SYN FLX WHT16/35MM PRECUT(1X10)
- REF
405473ESTEEM SYN FLX WHT35/35MM PRECUT(1X10)
- REF405479
- Lot codes and dates
- REF/UDI-DI/Lot
405473/00768455185399/3J03813405479/00768455185450/3J03814
- REF/UDI-DI/Lot
- Amount recalled
- 240
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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