BEUDAMED
    FDA Enforcement Class II Terminated

    Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.

    Recall: Z-1227-2015 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1227-2015
    Event ID
    70128
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Corporation Englewood
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    December 29, 2014
    Classification Date
    February 27, 2015
    Termination Date
    August 8, 2016
    Address
    14445 Grasslands Dr, N/A, Englewood, CO, 80112-7062, United States

    Description

    Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.

    Reason

    Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

    Code Info

    All DiscPac products are affected within expiry up to October 2017

    Distribution

    Nationwide Distribution

    Quantity

    1,404,230