BEUDAMED
    FDA Recall Terminated

    Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; 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 19208-01 Intended use: for the administration of fluids

    Recall: Z-0292-2012 · Initiated November 10, 2011

    Recall

    Recall Number
    Z-0292-2012
    Event Number
    60413
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 10, 2011
    Posted
    November 25, 2011
    Terminated
    December 15, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch , Soluset Microdrip with Option-Lok; 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 19208-01 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.

    Action

    The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated November 10, 2011 to the customers of record via UPS on the same date. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-866-913-0667 or email to: [email protected]; return affected product to Stericycle using the label provided with this letter; and if they have distributed the product further, notify their accounts that received the product . Please contact Hospira Customer Care at 1-877-946-7747 or your Hospira representative for information regarding product availability.

    Distribution

    Worldwide distribution: USA (nationwide) including states of: Alabama, Alaska, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, Washington and Wisconsin, and internationally to Canada

    Quantity

    12,580 units