Hemodialysis Delivery System, Software Version 2.x.
Reported: November 17, 2021 Initiated: September 29, 2021 #Z-0215-2022
Product Description
Hemodialysis Delivery System, Software Version 2.x.
Reason for Recall
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 4248
- Distribution
- Distributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC,SD, TN, TX, UT, VA, WA, WI and internationally to Mexico, Brazil, Canada, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Hemodialysis Delivery System, Software Version 2.x.. Recalled by Baxter Healthcare Corporation. Units affected: 4248.
Why was this product recalled? ▼
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 17, 2021. Severity: Moderate. Recall number: Z-0215-2022.
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