BEUDAMED
    FDA Recall Terminated

    Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

    Recall: Z-2371-2015 · Initiated June 3, 2015

    Recall

    Recall Number
    Z-2371-2015
    Event Number
    71543
    Firm
    Elite Biomedical Solutions LLC
    FEI Number
    3009712113
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 3, 2015
    Posted
    August 20, 2015
    Terminated
    March 7, 2017
    Address
    5150 Fordon Ct, Cincinnati, OH, 45244-5021

    Description

    Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.

    Reason

    Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death.

    Action

    Elite Biomedical Solutions, sent a "Product Advisory Notices" letter dated May 21, 2015 to their customers. On June 3, 2015 the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the affected product , problem and actions to be taken. And on June 12, 2015 a press release was issued via ECRI (Emergency Care Research Institute) to all hospitals in the US. The notification letter requested customers to: 1) inspect and quarantine affected products, 2) identify your customers and notify them at once of this product recall, and 3) complete and return the enclosed response forms. For any questions, call Elite Biomedical Solutions, LLC, Quality Manager, at 1-855-291-6701.

    Distribution

    Nationwide Distribution in the states of AZ, CA, GA, IL, IN, KS, KY, MA, MD, MN, MO, MS, NC, NY, OH, PA, SC, TN, TX, VA & WI.

    Quantity

    609 pieces