BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1630-2015 · Initiated March 20, 2015

    Recall

    Recall Number
    Z-1630-2015
    Event Number
    70828
    Firm
    CooperSurgical, Inc.
    FEI Number
    1216677
    Product Code
    NLM
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    March 20, 2015
    Posted
    May 19, 2015
    Terminated
    July 29, 2015
    Address
    75 Corporate Dr, Trumbull, CT, 06611-1350

    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.

    Action

    Consignees were notified of the recall by letter sent via FedEx dated March 20, 2015. The letter instructs consignees to do the following: discontinue use of the affected product, complete the attached acknowledgement and receipt form to return the product and schedule a replacement.

    Distribution

    US Nationwide distribution.

    Quantity

    430 units