BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1505-2013 · Initiated April 30, 2013

    Recall

    Recall Number
    Z-1505-2013
    Event Number
    65098
    Firm
    American Optisurgical Inc
    FEI Number
    1000135560
    Product Code
    OJU
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 30, 2013
    Posted
    June 6, 2013
    Terminated
    March 24, 2014
    Address
    26902 Vista Ter, Lake Forest, CA, 92630-8123

    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.

    Action

    American Optisurgical Inc. sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL AND PRODUCT EXCHANGE" letter dated May 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-580-1266 for questions regarding this notice.

    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