Events

Recall of Device Recall IntelliFill i.v. Pharmacy Compounding Device (PCD)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Healthcare Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66979
  • Event Risk Class
    Class 2
  • Event Number
    Z-0607-2014
  • Event Initiated Date
    2013-11-08
  • Event Date Posted
    2013-12-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124685
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System/device, pharmacy compounding - Product Code NEP
  • 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.

Device

Device Recall IntelliFill i.v. Pharmacy Compounding Device (PCD)
  • Model / Serial
    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.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA