BEUDAMED
    FDA Recall Terminated

    Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.

    Recall: Z-0059-05 · Initiated September 27, 2004

    Recall

    Recall Number
    Z-0059-05
    Event Number
    30115
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2004
    Posted
    October 28, 2004
    Terminated
    November 30, 2004
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.

    Reason

    Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK

    Action

    The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.

    Distribution

    The products were shipped to distributors in KS and VA, medical facilities in AR, FL, and GA, and a sales representative in FL.

    Quantity

    290 kits