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/ Manufacturer |
Baxter Healthcare Corp. 1 Baxter Pkwy Deerfield IL 60015-4625
|
For Additional Information Contact |
The Center for One Baxter 800-422-9837
|
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
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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.
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