BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-0233-2020 · Initiated September 6, 2019

    Recall

    Recall Number
    Z-0233-2020
    Event Number
    83993
    Firm
    ConvaTec, Inc
    FEI Number
    3011987967
    Product Code
    EXE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 6, 2019
    Terminated
    November 30, 2022
    Address
    7900 Triad Center Dr, Ste 400, Greensboro, NC, 27409-9076

    Description

    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

    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.

    Action

    The firm began notifying their consignees by telephone on 09/06/2019 and followed with a letter on 09/11/2019. The letter identifies the products and lots involved, describes the problem and states that Convatec will accept product returns of affected product.

    Distribution

    Worldwide distributions.

    Quantity

    8,008131 skin barriers