BEUDAMED
    FDA Recall 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 · Initiated July 13, 2012

    Recall

    Recall Number
    Z-2075-2012
    Event Number
    62582
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 13, 2012
    Posted
    July 25, 2012
    Terminated
    November 28, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    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.

    Action

    The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated July 13, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return Reply Form via fax to 1-877-722-7019 or e-mail to: [email protected]; return affected product to Stericycle using the label provided with the 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 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