BEUDAMED
    FDA Recall 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 · Initiated November 17, 2015

    Recall

    Recall Number
    Z-0478-2016
    Event Number
    72715
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3002615969
    Product Code
    KDQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 17, 2015
    Posted
    January 4, 2016
    Terminated
    September 28, 2016
    Address
    10232 S 51st St, Phoenix, AZ, 85044-5205

    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.

    Action

    The firm, Stryker Sustainability Solutions, sent a "URGENT MEDICAL DEVICE RECALL" letter dated 11/17/2015 to its customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to discontinue the use of the product, and complete the Recall Effectiveness Check Form even if no product has been found in inventory. Customers should return the completed Recall Effectiveness Check Form to their local Stryker Sustainability Sales Representative, email to [email protected], or mail to: Stryker Sustainability Solutions, 1810 West Drake Drive,Tempe, AZ 85283. If the firm indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have any questions, contact Senior Regulatory Affairs Specialist at (888) 888-3433x5506 or email: [email protected].

    Distribution

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

    Quantity

    34 devices