Events

Recall of Device Recall Amia Automated PD System with Sharesource

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
    73435
  • Event Risk Class
    Class 2
  • Event Number
    Z-1565-2016
  • Event Initiated Date
    2016-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144203
  • 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, peritoneal, automatic delivery - Product Code FKX
  • Reason
    Baxter healthcare corporation is sending this communication to inform you of incomplete instructions in the amia automated peritoneal dialysis (po) system clinician guide for calculating the total recommended solution therapy volume. specifically, the instructions do not specify the need for an extra 200 ml of pd solution in order to prime the patient line and for air purge operations. the tot.
  • Action
    An Urgent Device Correction communication was sent to the one affected customer via U.S.P.S., first class mail on 02/11/2016. A Clinician Guide Addendum was created to instruct clinicians of the extra 200 mL of PD solution required to prime the patient line and for air purge operations. This Addendum was provided as an attachment to the Urgent Device Correction communication letter.

Device

Device Recall Amia Automated PD System with Sharesource

Manufacturer

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