BEUDAMED
    FDA Enforcement Class I Terminated

    The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.

    Recall: Z-0478-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0478-2016
    Event ID
    72715
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Sustainability Solutions
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    November 17, 2015
    Classification Date
    January 4, 2016
    Termination Date
    September 28, 2016
    Address
    10232 S 51st St, N/A, Phoenix, AZ, 85044-5205, United States

    Description

    The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.

    Reason

    Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.

    Code Info

    Item Number G03974 Lot Number 295397U 331621U 374044U 394431U 406125U 406131U 410982U 412655U 415094U 422060U 519812U 7718289U 838193U

    Distribution

    US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.

    Quantity

    34 devices