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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter AMIA APD System

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  Class 2 Device Recall Baxter AMIA APD System see related information
Date Initiated by Firm April 03, 2014
Date Posted March 04, 2015
Recall Status1 Terminated 3 on July 21, 2017
Recall Number Z-1245-2015
Recall Event ID 70194
510(K)Number K102936  
Product Classification System, dialysate delivery, recirculating - Product Code FIK
Product AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Code Information Product Code: 5C9310
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
FDA Determined
Cause 2		 Error in labeling
Action Baxter sent IMPORTANT PRODUCT INFORMATION letters dated April 3, 2014 to all peritoneal dialysis healthcare providers of record. The letters advised healthcare providers of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the healthcare providers to complete and return the attached Customer Reply Form. Healthcare providers with clinical questions can contact Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2, 8:00 AM - 5:00 PM CT. Healthcare providers with general questions can contact The Center for One Baxter by telephone at 800-422-9837, Monday - Friday, 8:00 AM - 5:00 PM CT. Additionally, an IMPORTANT PRODUCT INFORMATION letters dated April 8, 2014 were sent to all peritoneal dialysis patients of record. The letters advised patients of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the patients to complete and return the attached Home Patient Reply Form. Patients with questions about the letter can contact The Center for One Baxter by telephone at 800-422-9837, Monday - Friday, 8:00 AM - 5:00 PM CT.
Quantity in Commerce 55 systems
Distribution US: Nationwide in the states of (GA, MA, NC, NY, PA, 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 = FIK and Original Applicant = BAXTER HEALTHCARE CORP.
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