BEUDAMED
    FDA Enforcement Class II Terminated

    Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.

    Recall: Z-1630-2015 · Reported May 27, 2015

    Enforcement

    Recall Number
    Z-1630-2015
    Event ID
    70828
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CooperSurgical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2015
    Initiation Date
    March 20, 2015
    Classification Date
    May 19, 2015
    Termination Date
    July 29, 2015
    Address
    75 Corporate Dr, N/A, Trumbull, CT, 06611-1350, United States

    Description

    Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.

    Reason

    The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes.

    Code Info

    Lot 174422

    Distribution

    US Nationwide distribution.

    Quantity

    430 units