Esteem Synergy Stomahesive Skin Barrier pre-cut wafers wrong size
ConvaTec's Esteem Synergy Stomahesive Skin Barrier packages may contain pre-cut wafers of 28mm instead of the labeled 16mm or 35mm, potentially causing skin abrasion or bleeding during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where incorrect sizing could result in skin injury (abrasion, stomal cuts, bleeding), but no injuries or hospitalizations have been reported. FDA Class II classification without reported injuries supports a High severity rating per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
ConvaTec, Inc. is recalling Esteem Synergy Stomahesive Skin Barrier packages distributed in Ohio, New York, and Illinois. The packages contain pre-cut wafers that measure 28mm instead of the labeled 16mm or 35mm sizes.
The Esteem Synergy is a two-piece ostomy system consisting of an adhesive skin barrier and pouch. Incorrect wafer sizing presents two risks: if the wafer is too large, the device cannot be properly used; if the wafer is too small, attempting to apply it could cause skin abrasion, stomal cuts, and bleeding.
Patients should discontinue use of affected products. Contact ConvaTec or your healthcare provider for replacement products.
The recalled product
- 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
- Manufacturer
- ConvaTec, Inc
- Affected units
- 240
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- REF/UDI-DI/Lot: 405473/00768455185399/3J03813
- 405479/00768455185450/3J03814
Distribution
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