Events

Recall of Device Recall System 1000, Arena, 1550, BM11, BM25, Meridian

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

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
    30507
  • Event Risk Class
    Class 2
  • Event Number
    Z-0367-05
  • Event Initiated Date
    2004-12-14
  • Event Date Posted
    2004-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36019
  • 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, Dialysate Delivery, Sealed - Product Code FII
  • Reason
    Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. air bubbles in the circuit can cause an air embolism.
  • Action
    An Urgent Device Correction letter dated 12/14/04 was sent along with a reply form and addenda to operator''s manuals to all Baxter customers who have purchased hemodialysis hardware. The letter informed the accounts of reports of air bubbles observed in the tubing sets past the air detector without an alarm alerting the operator of potential air in the tubing. A review of the reports revealed misuse, including failure to follow generally observed hemodialysis practices. Baxter updated their Hemodialysis Operator''s Manuals and Training Guides to clarify instructions and add caution and warning statements to address the possibility of introducing air in the extracorporeal circuit and to clarify methods for clearing air from the circuit. The accounts were requested to review the attached addendum that applies to the instruments used in their facility against the pertinent sections of their Operator''s Manual. If their Operator''s Manual does not match the addendum, they were instructed to order a new manual using the enclosed response form. Any questions were directed to Baxter''s Global Technical Services at 1-800-553-6898.

Device

Device Recall System 1000, Arena, 1550, BM11, BM25, Meridian
  • Model / Serial
    System 1000: serial numbers 1001S-1142S, 50001-52109, 01001-22223 Arena: serial numbers 300001-300640 1550: serial numbers 52599-67210 BM11: all serial numbers BM25: all serial numbers Meridian: serial numbers 200101-203156
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    This action covers Baxter''s complete line of hemodialysis hardware, which was distributed nationwide, including Puerto Rico, and internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Korea, Lebanon, Morocco, Malaysia, Netherlands, Oman, Panama, Peru, Philippines, Poland, Palestine, Romania, Russia, Saudia Arabia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and the United Kingdom.
  • Product Description
    System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA