BEUDAMED
    FDA Recall Terminated

    HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany

    Recall: Z-1866-2011 · Initiated February 11, 2011

    Recall

    Recall Number
    Z-1866-2011
    Event Number
    58136
    Firm
    Hartmann USA, Inc
    FEI Number
    1218946
    Product Code
    MGP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 11, 2011
    Posted
    April 1, 2011
    Terminated
    August 12, 2011
    Address
    481 Lakeshore Pkwy, Rock Hill, SC, 29730-4205

    Description

    HydroHydrofilm is for use as a post-operative and primary dressing to protect against secondary infection and to cover non-exudating wounds and for use as a secondary dressing for fixation of catheters or cannulae.film, 10cm x 12.5 cm, Paul Hartmann AG, 89522 Heidenhiem, Germany

    Reason

    Misbranded; the expiry date on the primary packing incorrectly indicates 2010-10, instead of 2015-10. Consignees were notified by letter on/about 02/11/2011. They were advised to examine their inventory and not to use any of the affected product and to return it to Paul Hartmann. A response form was included to be completed and returned to Paul Hartmann. They were further instructed to pass the no

    Action

    Hartmann USA, Inc. sent letter to the Consignees on 2/11/11. They were advised to examine their inventory and not to use any of the affected product and to return it to Hartmann USA, Inc. A response form was included to be completed and returned to Hartmann USA, Inc. They were further instructed to pass the notice on to their consignees if distributed. For questions, call (803) 325-7600.

    Distribution

    Nationwide -- Including CA, GA, IL, MO, MS, TX, and VA.

    Quantity

    100 boxes (10 x 12.5 cm per box)