AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Reported: February 27, 2019 Initiated: December 11, 2018 #Z-0849-2019
Product Description
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
Reason for Recall
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 7,688 devices
- Distribution
- Worldwide Distribution - US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Canada and Japan.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.. Recalled by Baxter Healthcare Corporation. Units affected: 7,688 devices.
Why was this product recalled? ▼
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 27, 2019. Severity: Moderate. Recall number: Z-0849-2019.
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