AMIA Automated Peritoneal Dialysis System Product recall: Software Issue
AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of…
Why was AMIA Automated Peritoneal Dialysis System Product recalled?
Potential for the software on Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code 5C9320. All serial numbers are affected for devices distributed from 02/11/2016 through 11/27/2018.
- Product
- AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of…
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 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.
- Recall date
- February 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)