BEUDAMED
    FDA Enforcement Class II Terminated

    FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.

    Recall: Z-1505-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1505-2013
    Event ID
    65098
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    American Optisurgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    April 30, 2013
    Classification Date
    June 6, 2013
    Termination Date
    March 24, 2014
    Address
    26902 Vista Ter, N/A, Lake Forest, CA, 92630-8123, United States

    Description

    FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.

    Reason

    American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.

    Code Info

    Lot Numbers 07912-06 12912-04

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.

    Quantity

    63 individual applicators