BEUDAMED
    FDA Recall Terminated

    Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 13744-28 For epidural administration of fluids with the Gemstar Pump

    Recall: Z-2027-2011 · Initiated March 28, 2011

    Recall

    Recall Number
    Z-2027-2011
    Event Number
    58276
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    KDC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2011
    Posted
    April 19, 2011
    Terminated
    May 9, 2012
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    Hospira Primary Microbore Gemstar Split Set, Integral PAV, Yellow Striped Tubing, 110 Inch, Non-DEHP; a sterile Rx tubing set for epidural administration of fluids with the Gemstar Pump; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA; List No. 13744-28 For epidural administration of fluids with the Gemstar Pump

    Reason

    There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.

    Action

    The firm, Hospira, sent an "URGENT DEVICE RECALL" letter dated March 28, 2011 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to check their inventory and immediately quarantine any affected product; complete and return the Reply Form via fax to 1-866-324-3734, even if you do not have the affected product; inform healthcare professionals in their organization of this recall; if they have distributed the product further, notify their accounts and have them fax the reply form to 1-866-324-3724; return the affected product to Stericycle using labels provided, and call Stericycle at 1-877-877-0481, if they have not received a return label. For medical inquiries, please call Hospira Medical Communications at 1-800-615-0187. Call Hospira Global Product Safety and Complaints at 1-800-441-4100 (8am-5pm CST, M-F) or by e-mail at ([email protected]).

    Distribution

    Worldwide distribution: USA (nationwide) and countries including: Canada, Korea and Singapore.

    Quantity

    61,150 sets