BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity

    Recall: Z-0157-2015 · Reported November 12, 2014

    Enforcement

    Recall Number
    Z-0157-2015
    Event ID
    58185
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Cardiovascular Systems Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 12, 2014
    Initiation Date
    March 1, 2011
    Classification Date
    October 31, 2014
    Termination Date
    November 6, 2014
    Address
    28 Howe St, N/A, Ashland, MA, 01721-1305, United States

    Description

    Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal activity

    Reason

    Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line

    Code Info

    Lot Numbers: ML13, MM04. Manufacturing datese September 13, 2010 through October 4, 20 I 0.

    Distribution

    Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.

    Quantity

    165 units