Events

Recall of Device Recall Baxter 1550 Hemodialysis Machine

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
    54373
  • Event Risk Class
    Class 2
  • Event Number
    Z-1322-2010
  • Event Initiated Date
    2010-01-29
  • Event Date Posted
    2010-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88343
  • 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, single patient - Product Code FKP
  • Reason
    Some of the 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software.
  • Action
    An "Urgent Device Correction" letter dated January 29, 2010 was sent to the direct accounts via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letter informed the accounts that subsequent to a prior device field correction in 2003-2004, some 1550 hemodialysis instruments may have replacement circuit boards with incorrect versions of software. The accounts were instructed to confirm the software version in their systems and replacement boards. Instructions for checking the software version were attached to the letter. A complementary software upgrade will be made available to the account if their 1550 instrument and/or spare circuit board inventory has a software version other than 3.0A or 4.1B. The accounts were also requested to complete and fax back to Baxter the enclosed reply sheet confirming receipt of the letter and listing the serial numbers and software versions of those instruments that do nit have software 3.0A or 4.1B. Home patients were not notified directly, the information was sent to their Dialysis Center. The 1550 operator's manual was revised during the 2003 device field correction. The manual correctly warns the operator to discontinue treatment if the 1550 experiences a FL04, FL07, or FLOg fault code. To make arrangements for the software upgrade or questions regarding the communication were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3. For additional questions, contact the company Monday through Friday from 8:00 AM to 5:00 PM CST at (Toll Free): 800-422-9837.

Device

Device Recall Baxter 1550 Hemodialysis Machine
  • Model / Serial
    All Baxter 1550 instruments and/or spare circuit boards that do not have software versions 3.0A or 4.1B
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States - nationwide and Puerto Rico, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela.
  • Product Description
    Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
  • 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