BEUDAMED
    FDA Enforcement Class II Terminated

    LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.

    Recall: Z-1479-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1479-2014
    Event ID
    67722
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    February 25, 2014
    Classification Date
    April 21, 2014
    Termination Date
    November 28, 2016
    Address
    275 N Field Dr, N/A, Lake Forest, IL, 60045-2579, United States

    Description

    LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Infusers.

    Reason

    Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.

    Code Info

    Product List Number: 112410403; Lot Numbers: 280055H, 341005H

    Distribution

    US Distribution including the states of FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA and WA.

    Quantity

    3,893 sets