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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter

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  Class 2 Device Recall Baxter see related information
Date Initiated by Firm April 24, 2014
Date Posted January 07, 2015
Recall Status1 Terminated 3 on July 21, 2017
Recall Number Z-0932-2015
Recall Event ID 69586
510(K)Number K124018  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
Code Information Product Code: 5C9310
Recalling Firm/
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact The Center for One Baxter
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
Action 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.
Quantity in Commerce 55 units
Distribution Nationwide Distribution including GA, MA, NC, NY, PA, and WA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FKX and Original Applicant = DEKA RESEARCH & DEVELOPMENT CORP.