BEUDAMED
    FDA Recall Terminated

    Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR 006 140 20

    Recall: Z-0816-04 · Initiated November 24, 2003

    Recall

    Recall Number
    Z-0816-04
    Event Number
    27855
    Firm
    Bacchus Vascular Inc
    FEI Number
    3003243511
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 24, 2003
    Posted
    July 20, 2004
    Terminated
    May 6, 2004
    Address
    3110 Coronado Dr, Santa Clara, CA, 95054-3205

    Description

    Bacchus brand Trellis Plus, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC TRR 006 140 20

    Reason

    The device has the potential for fractures at the distal end during use.

    Action

    On 11/24/03, all consignees were notified via phone calls and/or on-site visit by the firm''s sales representative, informing them of the affected devices and providing instructions on the recall.

    Distribution

    Product was released for distribution to 131 consignees in US. The firm identified 18 foreign distributors that received recall products. The product received nationwide distribution. The firm has also distributed products into international channels through distributors. Countries include: NETHERLANDS, Argentina, ISRAEL, Czech Republic, ARGENTINA, GERMANY, AUSTRIA, SWITZERLAND, IRELAND, HONG KONG, GERMANY, GREECE, Belgium, SOUTH AFRICA, UK, ITALY, UK, and NORWAY There is no known U. S. Government or Canadian distribution.

    Quantity

    1260 units