BEUDAMED
    FDA Recall Terminated

    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

    Recall: Z-0552-2016 · Initiated September 24, 2015

    Recall

    Recall Number
    Z-0552-2016
    Event Number
    72848
    Firm
    Airways Development LLC
    FEI Number
    3000210458
    Product Code
    BYE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 24, 2015
    Posted
    December 24, 2015
    Terminated
    May 9, 2016
    Address
    740 Jefferson Ave, Suite B, Kenilworth, NJ, 07033-1762

    Description

    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

    Reason

    Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if the whole lot is impacted.

    Action

    Airways Development Inc. sent Product Alert notices dated 9/24/2015 to their customers via email. The alert informed customers about the related product issue and how to identify affected product. Airways Development is replacing any affected product left in their customers stock. Customers were also instructed to notify their customers if the product was further distributed. A point of contact was provided if the customers had any related questions.

    Distribution

    Nationwide

    Quantity

    1,464 units