FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
- Recall number
- Z-1245-2015
- Recalling firm
- Baxter Healthcare Corp.
- Product
- AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
- Status
- Terminated
- Initiated
- 2014-04-03
- Posted
- 2015-03-04
- Terminated
- 2017-07-21
- Reason
- 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.
- Root cause
- 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
- 55 systems
- Distribution
- US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)
- Lot, serial or model codes
- Product Code: 5C9310
- 510(k) numbers
- ["K102936"]
- PMA numbers
- not on file
- Product code
- FIK
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28