BEUDAMED
    FDA Enforcement Class II Terminated

    Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

    Recall: Z-1016-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-1016-2017
    Event ID
    64220
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    February 19, 2013
    Classification Date
    January 11, 2017
    Termination Date
    April 24, 2017
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579, United States

    Description

    Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

    Reason

    Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.

    Code Info

    Product List Number: 14699-28; Lot Number: 17-077-NS

    Distribution

    Nationwide Distribution

    Quantity

    48,050 units