BEUDAMED
    FDA Recall Terminated

    LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 11235-03

    Recall: Z-0195-06 · Initiated May 6, 2005

    Recall

    Recall Number
    Z-0195-06
    Event Number
    31990
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    BRZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 6, 2005
    Posted
    November 24, 2005
    Terminated
    November 29, 2005
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the Plum Series Infuser; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 11235-03

    Reason

    Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow.

    Action

    Hospira sent product recall letters dated 5/6/05 to the accounts via Federal Express overnight letter on the same date. The letters informed the accounts of the possiblitiy of the inlet and outlet tubing being reversed on the cassette, which would allow the patient''s blood to be drawn up the tubing. 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 including Puerto Rico, and internationally to Mexico and Australia

    Quantity

    17,184 units