BEUDAMED
    FDA Recall Terminated

    DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management

    Recall: Z-1946-2011 · Initiated December 3, 2010

    Recall

    Recall Number
    Z-1946-2011
    Event Number
    57385
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    FEI Number
    1221934
    Product Code
    HBX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 3, 2010
    Posted
    April 12, 2011
    Terminated
    April 2, 2013
    Address
    325 Paramount Dr, Raynham, MA, 02767

    Description

    DePuy Mitek FMS Irrigation Intermediary Tube With One-way Valve Arthroscopy tubing Product Code: 281142 Fluid Tissue Management

    Reason

    Product sterility may be compromised due to breach in sterile packaging

    Action

    Depuy Mitek sent an Urgent Voluntary Product Recall letter dated December 2, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to isolate all inventory of the affected product and call 1-800-382-4682, PROMPT 3, for return good authorization and replacement product. Customers were instructed to return all identified affected product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 Record their assigned return material authorization (RMA) number on the outer shipping box. Use the Prepaid Federal Express shipping label for the return of the product. Include a photo copy of the completed business reply form. For questions or concerns call 1-800-382-4682, PROMPT 3.

    Distribution

    Worldwide Distribution - USA (nationwide) and the coutnries of United Arab Emirates, Australia, Belgium, Switzerland, Czech, Denmark, France, UK, Italy, Netherlands, Poland, and Slovakia.

    Quantity

    50,376 units