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# ‘Corrective Recall’ Asked for Hemodialysis Units
- URL: https://www.fdaweb.com/corrective-recall-asked-for-hemodialysis-units/
- Published: 2023-01-24T12:00:00.000Z
- Updated: 2026-09-14T18:12:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153611

A 1/20 citizen petition submitted by the Service Employees International Union — United Healthcare Workers West calls on FDA to issue a “corrective recall” requiring modifications to specific hemodialysis machines manufactured by Fresenius USA. The [petition](https://downloads.regulations.gov/FDA-2023-P-0219-0001/attachment%5F1.pdf?ref=fdaweb.com) asks that FDA require:

- a modification to include an ultrafiltration settings screen that calculates a patient’s ultrafiltration rate in a specified manner and displays the result of that calculation throughout the hemodialysis session;
- a modification to include a distinctive alarm when the ultrafiltration rate exceeds the specified level;
- a relabeling requirement to include a Boxed Warning with specified language indicating that an ultrafiltration rate above the specified level is associated with an increased risk of death;
- a relabeling requirement for labeling to include disinfection procedures for the hemodialysis machines as proposed by the union; and
- a modification to the Conductivity Alarm Position setting in the Dialysate Screen to allow a locked setting that would prevent adjustment of the Conductivity Alarm Window during treatment.