FDA recall Z-0233-2020

Product

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

Reason for recall

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.

Distribution

Worldwide distributions.

Key facts

Status

Terminated

Initiation date

2019-09-06

Report date

2019-11-06

Termination date

2022-11-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0233-2020