ConvaTec, Inc recalls Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2)…

Recall date

September 6, 2019

Source

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

Recall number

Z-0233-2020

FDA classification

Class II

Brand / firm

ConvaTec, Inc

Sold / distributed

Worldwide distributions.

Why it was recalled

ConvaTec has received complaints associated with use of convex two-piece skin barriers where the starter hole (stoma hole) is off-center on product manufactured from February 2017 to September 2018. FDA became aware of this problem via routine MDR monitoring.

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

What was recalled

Convex Two-Piece Ostomy System (Skin Barrier) marketed under the following brands: 1) Combihesive Natura Durahesive 2) SurFit Natura Durahesive 3) Natura 4) Varicare Product Usage: stoma management