BEUDAMED
    FDA Recall Terminated

    Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L.

    Recall: Z-0897-2007 · Initiated April 17, 2007

    Recall

    Recall Number
    Z-0897-2007
    Event Number
    37806
    Firm
    Surge Medical Solutions, LLC
    FEI Number
    3003964340
    Product Code
    DWF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 17, 2007
    Posted
    June 6, 2007
    Terminated
    March 10, 2009
    Address
    3710 Sysco Court S.E., Grand Rapids, MI, 49512

    Description

    Surge Medical Solutions 15 Fr. (5.0mm) Retrograde Cardioplegia Cannula, 18 mm self-inflating balloon, sure-touch handle, rigid insertion stylet, 12.5' length (31.8cm), sterile, REF CODE: RSH-M014S-L.

    Reason

    The device may leak between the two lumens or at the stop cock, which could result in inaccurate coronary sinus pressure readings.

    Action

    Consignees were notified and requested to return the recalled products via recall letter dated 4/17/07.

    Distribution

    Worldwide, USA, Argentina, Germany, Ireland, Italy, Lebanon, Saudi Arabia, Turkey, and the United Kingdom.

    Quantity

    2,211 for all Recalls Z-0892-0904-2007