Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
This recall has been terminated (originally issued January 7, 2015).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- April 24, 2014
- Posted
- January 7, 2015
- Terminated
- July 21, 2017
- Recall Number
- Z-0932-2015
- Quantity
- 55 units
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution including GA, MA, NC, NY, PA, and WA.
Lot / Code Info
Product Code: 5C9310
Root Cause
Under Investigation by firm
Action Taken
Baxter sent an IMPORTANT PRODUCT INFORMATION letter dated April 24, 2014 to all affected customers. The peritoneal dialysis provider consignees were instructed to: 1) complete the enclosed customer reply form and return it to Baxter; and, 2) contact Baxter Technical Services at 800-553-6898 should a System Event 01179 occur. Baxter Technical Services is available 24 hours a day, 7 days a week. Clinical questions can be directed to Baxter's Renal Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00 PM CT). General questions regarding the Import Product Information letter can be direct to The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CT). For questions regarding this recall call 800-422-9837.