ConvaTec, Inc recalls Convatec Esteem(TM) Synergy Stomahesive(R), 7/8 in. / 22mm, REF 405475 Product Usage: Esteem Synergy Stomahesive with F…

Recall date

April 25, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1890-2018

FDA classification

Class II

Brand / firm

ConvaTec, Inc

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.