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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/
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
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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