BEUDAMED
    FDA Recall Terminated

    Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use. The device is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart.

    Recall: Z-1907-2008 · Initiated April 1, 2008

    Recall

    Recall Number
    Z-1907-2008
    Event Number
    47828
    Firm
    Arrow International Inc
    FEI Number
    1036844
    Product Code
    LDF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 1, 2008
    Posted
    September 16, 2008
    Terminated
    December 8, 2009
    Address
    312 Commerce Pl, Asheboro, NC, 27203-0552

    Description

    Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number RF8015919, 5 Fr. (110 cm) Pacing Catheter, 6 Fr. Introducer Sheath, .035 inch diameter spring-wire guide, Single use. The device is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart.

    Reason

    The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr. Introducer Assembly.

    Action

    Consignees were notified by letter on/about 04/11/ 2008. They were instructed to cease use and distribution, and quarantine all affected product. They were also instructed to complete an enclosed Acknowledgement & Stock Status Form and fax back to Arrow International. Consignees were further advised to communicate the recall notice to anyone who has received the affected product by providing a copy of the recall notice to their customer(s). Contact Arrow International, Customer Relations Department at 800-523-8446 if you have questions.

    Distribution

    U.S. South Africa, Venezuela

    Quantity

    686 kits (286 kits of AI-07155-KS in the US + 400 kits of AI-07155-IK internationally)