BEUDAMED
    FDA Recall Terminated

    8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter

    Recall: Z-1271-2018 · Initiated November 22, 2017

    Recall

    Recall Number
    Z-1271-2018
    Event Number
    79445
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    LJT
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 22, 2017
    Terminated
    July 11, 2018
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936

    Description

    8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter

    Reason

    The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.

    Action

    Recall notification was issued, by mail to the customers on November 22, 2017. This notification requested that customers review inventory and return all un-used affected product after quarantine. Questions or concerns can be directed to 215-256-4201/

    Distribution

    CA, AR. AL

    Quantity

    24 Eaches