BEUDAMED
    FDA Recall Terminated

    10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set

    Recall: Z-0088-04 · Initiated October 22, 2003

    Recall

    Recall Number
    Z-0088-04
    Event Number
    27540
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    KZH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 22, 2003
    Posted
    November 1, 2003
    Terminated
    April 5, 2004
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    10 FR Super Arrow-Flex Percutaneous Sheath Introducer Set

    Reason

    package lid identifies the contents incorrectly

    Action

    The recalling firm notified the consignees via telephone on 10/22/03 regarding the problem and the need to return the product.

    Distribution

    The products were shipped to medical facilities in AR, CA, NH, VA and VT. The product was also shipped to a distributor in Srialanka

    Quantity

    80 units