# FDA recall Z-0215-2022

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2021-09-29.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-0215-2022
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-29
- **Report date:** 2021-11-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0215-2022

## Citation

> AI Analytics. FDA recall Z-0215-2022. Retrieved 2026-08-03 from https://api.ai-analytics.org/recall/Z-0215-2022. Source: US FDA. Licensed CC0.

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