BEUDAMED
    FDA Recall Terminated

    I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management.

    Recall: Z-2111-2009 · Initiated February 11, 2008

    Recall

    Recall Number
    Z-2111-2009
    Event Number
    50802
    Firm
    I-Flow Corporation
    FEI Number
    3011270181
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 11, 2008
    Posted
    September 14, 2009
    Terminated
    February 4, 2010
    Address
    20202 Windrow Dr, Lake Forest, CA, 92630-8152

    Description

    I-Flow Corporation Easy Pump LT 60-24 (60 ml x 2 ml/hr), REF: 04434366, assembled in Mexico. The Easypump LT is indicated for continuous and/or intermittent infusion of medication for general infusion use, including antibiotic delivery, chemotherapy and pain management.

    Reason

    I-Flow Corporation received two complaints involving Easypump LT 60-24 (Lot 612996) containing a 100 ml x 2 ml/hr pump in the sterile package instead of a 60 ml x 2 ml/hr pump (Illustration was included to show consignee what both the correct and incorrect part looks like). Lot 612996 was manufactured on January 6, 2006. As of February 7, 2008, there have been no further complaints received on t

    Action

    I-Flow Corp. issued an "Important Recall Information" letter dated February 7, 2008 informing Consignees to quarantine and return any remaining inventory and notify any end users of the affected lot. For further information, contact I-Flow Corp. at 1-949-206-2653.

    Distribution

    Nationwide Distribution to B. Braun, Spain, who then further distributed to Italy, Germany, Netherland, Latvia, Spain, Portugal and Singapore.

    Quantity

    4,450 Distributed