medical Class II Updated 2018-05-23

ConvaTec, Inc recalls Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm,

Recalled 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.


Hazard / Issue

It was discovered that the stoma hole of one lots of the Esteem synergy Stomahesive Skin Barrier wafers is larger that the 7/8 inch / 22mm specified on the box label.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number 7F00987
View official government recall

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