BEUDAMED
    FDA Enforcement Class II Terminated

    *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

    Recall: Z-2060-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2060-2016
    Event ID
    66372
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    September 9, 2013
    Classification Date
    June 29, 2016
    Termination Date
    December 6, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579, United States

    Description

    *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

    Reason

    Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

    Code Info

    ***** CANADA DISTRIBUTION ***** *** 1) List Number 14220-28-01

    Distribution

    US (Nationwide) Distribution

    Quantity

    3,920,932 units in total