BEUDAMED
    FDA Enforcement Class II Terminated

    GENERAL PURPOSE INSTRUMENT TRAY

    Recall: Z-1080-2018 · Reported March 28, 2018

    Enforcement

    Recall Number
    Z-1080-2018
    Event ID
    79329
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 28, 2018
    Initiation Date
    October 23, 2017
    Classification Date
    March 17, 2018
    Termination Date
    June 21, 2018
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    GENERAL PURPOSE INSTRUMENT TRAY

    Reason

    Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.

    Code Info

    75121 75175 71435 75455 75690 SR245 Lot codes: 2017071990 2016110990 2016040790 2017022090 2016112490 2017010390 2017082390 2015101290 2015111790 2016032290 2016051790 2016053090 2016102490 2017013190 2017032990 2017080290 2015110390 2016010490 2016012090 2016020890 2016041890 2016061390 2016090590 2016110790 2017010990 2017021390 2017032190 2015092190 2015120190 2015121490 2016022590 2016120190 2017010390 2017011090 2015093090 2015112390 2016020390 2016092290 2016091590

    Distribution

    Nationally

    Quantity

    N/A