BEUDAMED
    FDA Recall Terminated

    LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01

    Recall: Z-0542-2007 · Initiated December 20, 2006

    Recall

    Recall Number
    Z-0542-2007
    Event Number
    37014
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2006
    Posted
    February 27, 2007
    Terminated
    March 24, 2008
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01

    Reason

    The tubing can separate from the set at the filter inlet post.

    Action

    Hospira sent product recall letters dated 12/20/06 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts that the tubing can separate from the set at the filter inlet post due to an inadequate solvent bond. The accounts were requested to examine their inventory for the affected lot, quarantine any found and call Hospira Customer Care at 1-877-946-7747 to arrange for return of the product for replacement.

    Distribution

    Nationwide.

    Quantity

    7,656 sets