Events

Recall of Device Recall Phoenix Monitor

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

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
    76168
  • Event Risk Class
    Class 2
  • Event Number
    Z-1094-2017
  • Event Initiated Date
    2017-01-04
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152438
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Reason
    Baxter healthcare corporation is issuing a voluntary product recall for several lots of phoenix dialysis machine preventive maintenance kits due to incorrect silicone straight connectors components packaged in these kits. during preventive maintenance, the two silicone connectors must be installed in the phoenix mass-balance section of hydraulic circuit only if the phoenix machine has already been modified with "conn. improving retr. kit" (code sp00721). installation of these connectors in machines modified with sp00721 may result in fluid leaks during dialysis treatment. these preventive maintenance kits include the filter sub-group, which contains the silicone straight connectors that are larger than expected.
  • Action
    Baxter sent an Urgent Product Recall on January 4, 2016, to all affected customers via U.S.P.S., first class mail. Customers were asked to: 1) Locate and remove all affected product lots from their facility. 2) Check if the Preventative Maintenance Kits were already installed in their Phoenix machines and if the case or if uncertain, contact their Baxter Service Representative at 1-800-525-2623 (Option 2) to schedule an appointment to remediate the machine. 3) Contact Baxter Health care Center for Service to arrange for return and credit. 4) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email. All non-responding customers will be contacted via telephone. All affected product will be destroyed or discarded. Customers with questions were advised to call 800-437-5176.

Device

Device Recall Phoenix Monitor
  • Model / Serial
    Product code: 6997266; Lot codes: 1607250, 160824D, 161005D, 161026D
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Maintenance Kit PH1, Cod. 6997266 || The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

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