BEUDAMED
    FDA Recall Terminated

    Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990

    Recall: Z-0122-2007 · Initiated August 10, 2005

    Recall

    Recall Number
    Z-0122-2007
    Event Number
    36507
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 10, 2005
    Posted
    November 1, 2006
    Terminated
    May 16, 2012
    Address
    Scientific Place Natick, MA, 01760-1536

    Description

    Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990

    Reason

    Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04

    Action

    Recall notification packages including a Reply Verification Tracking Form were sent to Boston Scientific representatives via Fed Ex on 8/10/2005. Boston Scientific representatives delivered the packages to the consignees. The Consignees were instructed to return affected product to Boston Scientific to be relabeled.

    Distribution

    TX, KY

    Quantity

    5 units