BEUDAMED
    FDA Recall Terminated

    Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.

    Recall: Z-1653-2009 · Initiated June 17, 2009

    Recall

    Recall Number
    Z-1653-2009
    Event Number
    52388
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 17, 2009
    Posted
    July 7, 2009
    Terminated
    December 3, 2009
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow Pediatric Two-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, 5 Fr., 2 Lumen, 13cm catheter length, Catalog number: CS-14502.

    Reason

    The spring wire guide is too large in diameter to pass through the needle, dilator and catheter.

    Action

    Arrow notified consignees by letter on/about 06/17/2009. They were instructed to cease use and distribution and quarantine all affected product. They were to contact Arrow's Customer Service Department for a Return Authorization Number. Enclosed was a Recall Acknowledgement & Stock Status Form to be completed and faxed to Arrow International to verify receipt of notification and acknowledge the amount of return.

    Distribution

    Worldwide distribution, including USA, Argentina, Brazil, India, Taiwan and Thailand.

    Quantity

    3019 units