BEUDAMED
    FDA Recall Terminated

    Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.

    Recall: Z-1199-2010 · Initiated January 6, 2010

    Recall

    Recall Number
    Z-1199-2010
    Event Number
    54453
    Firm
    Medrad Inc
    FEI Number
    2520313
    Product Code
    DXT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 6, 2010
    Posted
    March 23, 2010
    Terminated
    April 8, 2010
    Address
    1 Medrad Dr, Indianola, PA, 15051-9759

    Description

    Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231.

    Reason

    The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.

    Action

    The recalling firm issued an Urgent Medical Device Recall letter dated 1/6/10 to all customers that received the affected lots. The customers were instructed to determine whether or not they had the affected product lots. Customers are to discontinue use and contact MEDRAD Customer Support or their MIP Rep to make arrangements for return of the recalled product. Any affected product returned will be replaced at no charge to the customer. Customers are also to complete and sign the attached form and fax it back to the firm. Questions concerning this recall are to be directed to Deb Easler, Product Manager, at 412-767-2400.

    Distribution

    Worldwide Distribution -- USA, including stated of AL, AZ, CA, DC, FL, GA, IL, KS, MD, MO, NM, NY, OH,OK, PA, TN, TX, and WI. and countries of Belgium, Germany, and Italy.

    Quantity

    2625 pieces