BEUDAMED
    FDA Enforcement Class II Terminated

    OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.

    Recall: Z-1732-2017 · Reported April 12, 2017

    Enforcement

    Recall Number
    Z-1732-2017
    Event ID
    76730
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2017
    Initiation Date
    March 9, 2017
    Classification Date
    April 5, 2017
    Termination Date
    August 7, 2017
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    OPHTHALMIC DRS TRAY The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other components.

    Reason

    Centurion Medical Products is recalling Convenience Kits that contain Covidien Curity Oval Eye Pads due to supplier's recall because of potential breach in sterile packaging.

    Code Info

    Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016081550 4/30/19 2016080950 4/30/19 2016072250 12/31/18 2016051350 10/31/18 2016030550 4/30/18 2016022350 4/30/18 2016011850 4/30/18 2015122150 4/30/18 2015121450 4/30/18 2015101250 4/30/18 2015070750 2/28/18 2015062950 2/28/18 2015061950 1/31/18 2015062250 2/28/18 2015051850 1/31/18 2015050450 2/28/18 2015042850 11/30/17 2015031950 11/30/17 2015010750 10/31/17 2014103150 7/31/17 2014102750 7/31/17 2014073050 5/31/17

    Distribution

    US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

    Quantity

    588 kits