BEUDAMED
    FDA Recall Terminated

    Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.

    Recall: Z-1889-2008 · Initiated January 16, 2008

    Recall

    Recall Number
    Z-1889-2008
    Event Number
    46377
    Firm
    Cooper Surgical, Inc.
    FEI Number
    1216677
    Product Code
    HDB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 16, 2008
    Posted
    September 17, 2008
    Terminated
    May 23, 2012
    Address
    95 Corporate Dr, Trumbull, CT, 06611-1350

    Description

    Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System (Ref: 10057). Product is intended to assist a clinician in the delivery of an infant during childbirth. Indicated for use during vaginal delivery and Cesarean sections.

    Reason

    Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby.

    Action

    On 1/16/08 Cooper Surgical issued an Urgent Notice of Recall via Fed Ex for USA destinations and via e-mail and facsimile for international destinations, and firm confirmed receipt. The letter requests that accounts return recalled product. The recall was extended to three additional lots, and an Urgent Recall Notice dated 3/18/08 was issued. If you have any questions contact Thomas Williams at (203) 601-4741.

    Distribution

    Class II Recall - Worldwide Distribution --- including USA and Australia, Canada, Hong Kong, Latin America, Israel, and New Zealand.