BEUDAMED
    FDA Enforcement Class II Terminated

    Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.

    Recall: Z-3034-2018 · Reported September 19, 2018

    Enforcement

    Recall Number
    Z-3034-2018
    Event ID
    80317
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SPS Sterilization, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2018
    Initiation Date
    March 7, 2018
    Classification Date
    September 13, 2018
    Termination Date
    November 27, 2018
    Address
    1110 N Gerald St, N/A, Nixa, MO, 65714-7445, United States

    Description

    Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.

    Reason

    The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

    Code Info

    Code Number OPTI22-R; Lot Number 59637295; Serial Number 16502032017-01

    Distribution

    US distribution to AZ, CA, FL, OH, PA, TX, VA, WV

    Quantity

    1 unit total