Recall Z-0619-2024— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0619-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-24

Class III · Ongoing

Class III FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2023-10-24. It names one FDA 510(k) clearance: K222318. Product: Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111. Reason: Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class III
Status: Ongoing
Initiated: 2023-10-24
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K222318 — Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLC·cleared 2022-10-31

K-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

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

Reason for recall

Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

Data sourced from openFDA. This site is unofficial and independent of the FDA.