Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1890-2018·Announced 2018-05-23

Convatec Esteem Synergy Stomahesive Skin Barrier Recalled for Size Defect

ConvaTec is recalling 200 boxes of Esteem Synergy Stomahesive skin barriers because the stoma hole is larger than the 22mm size specified on the label.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect is a dimensional labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

ConvaTec, Inc. is recalling 200 boxes of 10 units of Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475. The product is a precut skin barrier used with Esteem Synergy pouches to manage stomal output. The recall involves Lot Number 7F00987, which was distributed nationwide in the United States.

The recall was initiated because it was discovered that the stoma hole of the skin barrier wafers in this specific lot is larger than the 7/8 inch / 22mm size specified on the box label. This dimensional discrepancy may affect the fit of the ostomy system.

Consumers who have this product should stop using it and contact ConvaTec for further instructions or a replacement.

The recalled product

Product: Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with Flexible Collar 22mm Precut Skin Barrier is used together with Esteem Synergy pouches as an ostomy system intended for the management of stomal output.
Manufacturer: ConvaTec, Inc
Category: Medical Device — Ostomy Supplies
Hazard: mis-labeling
dimensional-defect

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 (1)

Lot Number 7F00987

Distribution

Distributed nationwide across the United States.

Same manufacturer · ConvaTec, Inc

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