BEUDAMED
    FDA Recall Terminated

    ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box.

    Recall: Z-1814-2009 · Initiated July 13, 2009

    Recall

    Recall Number
    Z-1814-2009
    Event Number
    52680
    Firm
    ConvaTec
    FEI Number
    3011987967
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 13, 2009
    Posted
    September 29, 2009
    Terminated
    October 2, 2009
    Address
    200 Headquarters Park Dr, Skillman, NJ, 08558

    Description

    ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box.

    Reason

    Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.

    Action

    Recall notification letters were hand delivered on July 13, 2009 to all direct customers (tier 1) by ConvaTec reps. Letters were provided to all direct customers so that they could notify all customers that received the product.

    Distribution

    Nationwide distribution and ConvaTec sales rep in the UK and France.

    Quantity

    764