BEUDAMED
    FDA Enforcement Class II Terminated

    IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.

    Recall: Z-0607-2014 · Reported January 8, 2014

    Enforcement

    Recall Number
    Z-0607-2014
    Event ID
    66979
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 8, 2014
    Initiation Date
    November 8, 2013
    Classification Date
    December 29, 2013
    Termination Date
    March 23, 2015
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.

    Reason

    Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled.

    Code Info

    Lot # 123, 125R, 127, 129, 145, 146R, 147R, 148, 215R, 500, 501, 502, 503, 504, 505, 506, 508, 510, 511R, 512, 514, 515, 516R, 517, 518, 519, and 520.

    Distribution

    Nationwide Distribution including the states of CA, CO, CT, FL, IL, LA, MA, MD, MI, NC, NE, NY, OH, OR, PA, TN, TX, and WV.

    Quantity

    28 devices