Z-0849-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 27, 2019
- Initiation Date
- December 11, 2018
- Termination Date
- February 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,688 devices
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
Distribution Pattern
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.
Code Information
Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018.