BEUDAMED
    FDA Recall Terminated

    Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025

    Recall: Z-0559-06 · Initiated January 20, 2006

    Recall

    Recall Number
    Z-0559-06
    Event Number
    34524
    Firm
    Acclarent Inc
    FEI Number
    3005172759
    Product Code
    LRC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 20, 2006
    Posted
    February 24, 2006
    Terminated
    May 11, 2006
    Address
    1525-B O'Brien Drive, Menlo Park, CA, 94025

    Description

    Acclarent brand Relieva Sinus Inflation Device Kit; Model BID30; The kit contains 1 inflation device, 1-10'' extension tube, 1-20cc syringe, 3-way stop-cock; Manufactured for Acclarent, Inc., 1525-B O''Brien Dr., Menlo Park, CA 94025

    Reason

    Device sterility may be compromised as evidenced by a loss of package integrity.

    Action

    On 1/20/06 the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

    Distribution

    The product was released for distribution to 15 consignees in US. The recall was appropriately extended to the consumer/user level; i.e., the direct accounts (users) who received the recalled product. There is one Veterans Affairs account: Dept. of Veterans Affairs Medical Center PA, 1 215 823-4659, University & Woodland Avenues, Philadelphia, PA 19104, USA

    Quantity

    149 units