BEUDAMED
    FDA Recall Terminated

    Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Product Code 44968 00; C-Section Drape with Pouch and Fenestration (Non-Sterile), Product Code 44977 NS; C-Section Drape with Pouch and Fenestration (Sterile), Product Code 44978 00 Product Usage: A surgical drape is a device made of natural or synthetic materials intended to be use as a protective patient covering, such as to isolate a site or surgical incision from microbial and other contamination.

    Recall: Z-0724-2017 · Initiated November 9, 2016

    Recall

    Recall Number
    Z-0724-2017
    Event Number
    75683
    Firm
    Halyard Health, Inc
    FEI Number
    3011270181
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 9, 2016
    Posted
    December 8, 2016
    Terminated
    February 22, 2017
    Address
    5405 Windward Pkwy, Alpharetta, GA, 30004-3894

    Description

    Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Product Code 44968 00; C-Section Drape with Pouch and Fenestration (Non-Sterile), Product Code 44977 NS; C-Section Drape with Pouch and Fenestration (Sterile), Product Code 44978 00 Product Usage: A surgical drape is a device made of natural or synthetic materials intended to be use as a protective patient covering, such as to isolate a site or surgical incision from microbial and other contamination.

    Reason

    Drapes within the affected lots may include a manufacturing variation that prevents convenient removal of the coated release paper, which inhibits easy access to the surgical site.

    Action

    Accounts were notified of the recall by letter on 11/9/2016. The consignees were instructed to quarantine and discontinue use of the recalled lots and to discard/destroy per the facility's standard disposal procedure for nonwoven materials. A response form was included which was to be sent back.

    Distribution

    US Nationwide Distribution in the states of AL, FL, GA, IL, KS, MN, MO, NE, NJ, OH, PH, TN, VA, WI, WY

    Quantity

    132 cases