BEUDAMED
    FDA Recall Terminated

    Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.

    Recall: Z-0297-06 · Initiated November 7, 2005

    Recall

    Recall Number
    Z-0297-06
    Event Number
    34028
    Firm
    Thomas Medical Products Inc
    FEI Number
    3010665433
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2005
    Posted
    December 17, 2005
    Terminated
    June 14, 2006
    Address
    65 Great Valley Pkwy, Malvern, PA, 19355-1302

    Description

    Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case.

    Reason

    mislabeled as 9.5F actually contains 10.5F

    Action

    The recalling firm issued letters to their direct accounts via fax on 11/7/05. Letters to the hospital accounts were mailed via UPS overnight on 11/14/05.

    Distribution

    The products were shipped to one distributor in CA and the label holder in MA. The products were further distributed to hospitals in CA, CO, IL, KY, MO, MS, NC, NE, NY, OH, PA, SC, and TX.

    Quantity

    445 kits