Recall Z-1026-2017— Fresenius Medical Care Renal Therapies Group, LLC
Class II · Terminated
Class II FDA medical device recall by Fresenius Medical Care Renal Therapies Group, LLC, initiated 2016-12-21, terminated 2023-03-17. It names one FDA 510(k) clearance: K150708. Product: Fresenius 2008T Series Hemodialysis System. Reason: When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-12-21
- Terminated
- 2023-03-17
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Fresenius 2008T Series Hemodialysis System
Reason for recall
When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
Data sourced from openFDA. This site is unofficial and independent of the FDA.