BEUDAMED
    FDA Recall Terminated

    Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.

    Recall: Z-0183-2009 · Initiated September 12, 2008

    Recall

    Recall Number
    Z-0183-2009
    Event Number
    49540
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 12, 2008
    Posted
    October 22, 2008
    Terminated
    September 19, 2012
    Address
    1625 W 3rd St, Tempe, AZ, 85281-2438

    Description

    Bard Vacora Biopsy Vacuum Assisted Biopsy Probe; Catalog numbers VB10118 and VB10140.

    Reason

    Some of the Vacora Biopsy Vacuum Assisted Biopsy Probe thumb wheels from these lots may fracture when fired using the prime/pierce option.

    Action

    Product Recall Notification Letter sent dated September 11, 2008 Attention: Risk Managers "All VB10118 and VB10140 catalog numbers with expiry dates prior to September 2008 are now beyond their expiration date. In accordance with accepted medical practice, they should have been discarded and not used. Do not use or further distribute any affected products. Once the product affected by the recall has been removed from your inventory; fill out the recall & effectiveness check form, call Silvia Carrillo at 1-800-321-4254 ext 2727 to issue your with either a Return Authorization Number or Consignment Recall Number. fax the form to BVP at 1-800-440-5376

    Distribution

    Nationwide Distribution --- including states of AL, AR, CA, FL, KY, MA, NY, OH, SC, TN, TX, VA, and WA.

    Quantity

    225