BEUDAMED
    FDA Recall Terminated

    DeVilbiss Model 7305P-D Powered Suction Unit

    Recall: Z-2246-2016 · Initiated May 23, 2016

    Recall

    Recall Number
    Z-2246-2016
    Event Number
    74308
    Firm
    DeVilbiss Healthcare LLC
    FEI Number
    2515872
    Product Code
    JCX
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 23, 2016
    Posted
    July 20, 2016
    Terminated
    May 30, 2017
    Address
    100 Devilbiss Dr, Somerset, PA, 15501-2125

    Description

    DeVilbiss Model 7305P-D Powered Suction Unit

    Reason

    A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation.

    Action

    DeVilbiss Healthcare sent an Urgent - Medical Device Recall letter on May 23, 2016, to all affected customers notifying them of the issue. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed to isolate all of the affected units included on the serial number list and return for replacement. For further questions, please call (814) 443-7602.

    Distribution

    US Distribution to the states of : NC, OH, TX, MO, TN, WI, KY, FL, LA, MN, IN, and SC

    Quantity

    48 units