BEUDAMED
    FDA Recall Terminated

    B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr

    Recall: Z-2250-2009 · Initiated August 1, 2008

    Recall

    Recall Number
    Z-2250-2009
    Event Number
    53080
    Firm
    I-Flow Corporation
    FEI Number
    3011270181
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 1, 2008
    Posted
    September 24, 2009
    Terminated
    October 7, 2009
    Address
    20202 Windrow Dr, Lake Forest, CA, 92630-8152

    Description

    B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr

    Reason

    I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package. Used to provide an optional filling device for the Easypump.

    Action

    I-Flow sent a recall letter dated August 1, 2008 to consignees telling them of the above mentioned recall and asking them to Inspect their Easypump inventory to determine if they have any of the affected lots identified on this Recall Notification Letter. They were told not to distribute affected devices and quarantined remaining inventory immediately. They were asked to check the appropriate response on the attached I-Flow Fax sheet and return the form back to I-Flow within 48 hours of receipt. The I-Flow Customer Service number (949) 206-2700, and hours of operation (7:00 am - 5:00 pm PST) were provided to answer questions.

    Distribution

    France

    Quantity

    1,608 units