BEUDAMED
    FDA Enforcement Class II Terminated

    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

    Recall: Z-2235-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2235-2021
    Event ID
    88348
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cordis Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    July 19, 2021
    Classification Date
    August 9, 2021
    Termination Date
    February 16, 2023
    Address
    14201 NW 60th Ave, N/A, Miami Lakes, FL, 33014-2802, United States

    Description

    Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X

    Reason

    The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.

    Code Info

    Lot/Batch number 82219442

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.

    Quantity

    8 units