Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Baxter

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Baxtersee related information
Date Initiated by FirmApril 24, 2014
Date PostedJanuary 07, 2015
Recall Status1 Terminated 3 on July 21, 2017
Recall NumberZ-0932-2015
Recall Event ID 69586
510(K)NumberK124018 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductBaxter 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 ContactThe 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
ActionBaxter 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 Commerce55 units
DistributionNationwide Distribution including GA, MA, NC, NY, PA, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FKX
-
-