BEUDAMED
    FDA Enforcement Class II Terminated

    Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.

    Recall: Z-2075-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2075-2012
    Event ID
    62582
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    July 13, 2012
    Classification Date
    July 25, 2012
    Termination Date
    November 28, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579, United States

    Description

    Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 USA; list 12722-65. Intended use: for the administration of fluids.

    Reason

    The float valve in the burette sticks to the burette wall and does not open or close properly.

    Code Info

    list 12722-65, lot number 96-098-5H

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of California, Colorado, Connecticut, Florida, Illinois, Kentucky, Maryland, Massachusetts, Minnesota, Oklahoma, Texas, Utah, Virginia, Washington, West Virginia and Wyoming, and the countries of Barbados and Canada.

    Quantity

    4,420 sets