BEUDAMED
    FDA Enforcement Class II Terminated

    NIPRO Safe Touch Safety Scalp Vein Set

    Recall: Z-1834-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1834-2014
    Event ID
    65274
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nipro Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    May 4, 2013
    Classification Date
    June 19, 2014
    Termination Date
    March 2, 2015
    Address
    3150 Nw 107th Ave, N/A, Miami, FL, 33172, United States

    Description

    NIPRO Safe Touch Safety Scalp Vein Set

    Reason

    There is a possibility of a crack in the CP luer connector. The position of the crack is at the connection site of the CP luer connector and the tubing. The crack could cause or contribute to leakage of fluids.

    Code Info

    Product Code: PR+25G19, Lots #s 12H31H and 12I14H; Product Code: SPR+21G19, Lots #s 12I24 and 12J11; Product Code: PR-25G19, Lot # 12H27H; and PR-23G19, Lot # 12I12H.

    Distribution

    Worldwide Distribution - USA and the countries of Canada, Bolivia, Chile, Uruguay, Belize, Dominica, Honduras, Jamaica, Paraguay and Venezuela.

    Quantity

    176,000 pieces