BEUDAMED
    FDA Recall 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 · Initiated November 8, 2013

    Recall

    Recall Number
    Z-0607-2014
    Event Number
    66979
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 8, 2013
    Posted
    December 29, 2013
    Terminated
    March 23, 2015
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    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.

    Action

    A Service Bulletin was sent to all IntelliFill i. v. customers February 22, 20 I 0 by USPS mail. The Service Bulletin informs customers that IntelliFill i.v. operators are to be trained to listen for the running HEPA filtration fan motor and observe/feel for airflow coming from the automation deck. The field service engineer dispatched to the site replaced the damaged sensor on 11-Feb-2010 and a Service Bulletin was sent to all customers regarding the function and use of the HEPA filter on 22-Feb-2010. A new HEPA sensor was designed and installed into all current IntelliFill i.v. devices between 21-July-2011 to 9-Feb-2012.

    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