Z-1245-2015 Class II Terminated
FDA device recall Z-1245-2015 was initiated by Baxter Healthcare Corp. on Apr 3, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jul 21, 2017). Affected quantity: 55 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 11, 2015
- Initiation Date
- Apr 3, 2014
- Termination Date
- Jul 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55 systems
Product Description
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
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.
Distribution Pattern
US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)
Code Information
Product Code: 5C9310
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1245-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026