BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1987-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1987-2014
    Event ID
    68495
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microline Surgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    May 12, 2014
    Classification Date
    July 2, 2014
    Termination Date
    August 13, 2015
    Address
    800 Cummings Ctr Ste 166t, Beverly, MA, 01915-6171, United States

    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

    Code Info

    Lot Numbers: Lot Number 00115282 Lot Number 00115283 Lot Number 00115284 Lot Number 00115340 Lot Number 00115341 Lot Number 00115501 Lot Number 00115502 Lot Number 00115865 Lot Number 00116277 Lot Number 00116278

    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