BEUDAMED
    FDA Recall Terminated

    Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222

    Recall: Z-1987-2014 · Initiated May 12, 2014

    Recall

    Recall Number
    Z-1987-2014
    Event Number
    68495
    Firm
    Microline Surgical, Inc.
    FEI Number
    1000137656
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 12, 2014
    Posted
    July 2, 2014
    Terminated
    August 13, 2015
    Address
    800 Cummings Ctr, Ste 166t, Beverly, MA, 01915-6171

    Description

    Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222

    Reason

    Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw

    Action

    Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions.

    Distribution

    Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.

    Quantity

    6290 units