BEUDAMED
    FDA Recall Terminated

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    Recall: Z-1065-2013 · Initiated November 27, 2012

    Recall

    Recall Number
    Z-1065-2013
    Event Number
    64527
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 27, 2012
    Posted
    April 6, 2013
    Terminated
    June 2, 2015
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    Reason

    Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

    Action

    Arrow International issued Urgent Medical Device Recall notification on 11/27/12. The letter identified the affected product and the reason for the recall. Accounts are requested to check their stock for the products included within the scope of this recall. Also, customers should cease use and distribution, and quarantine all affected product immediately. Contact Arrow's Customer Service Department at 800-523-8446 for a Return Authorization Number. Customers are to complete and fax the Recall Acknowledgement & Stock Status Form to the number provided, and return the affected product. If customers have questions or need clarification regarding this issue, they should contact Arrow's Customer Service Department at 1-800-523-8446.

    Distribution

    Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.

    Quantity

    637 units