PlainRecalls
FDA Devices Moderate Class II Terminated

Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

Reported: January 14, 2015 Initiated: April 24, 2014 #Z-0932-2015

Product Description

Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

Reason for Recall

System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
55 units
Distribution
Nationwide Distribution including GA, MA, NC, NY, PA, and WA.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.. Recalled by Baxter Healthcare Corp.. Units affected: 55 units.
Why was this product recalled?
System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 14, 2015. Severity: Moderate. Recall number: Z-0932-2015.