FDA-Device2019-11-06Class II
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
ConvaTec, Inc
Hazard
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.
Sold states
Worldwide distributions.
Affected count
8,008131 skin barriers
Manufactured in
7900 Triad Center Dr Ste 400, Greensboro, NC, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0233-2020Don't want to check this manually?
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