Recall Z-2085-2021— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-2085-2021
Creator: U.S. Food and Drug Administration
Published: 2021-04-28

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2021-04-28, terminated 2022-08-08. It names one FDA 510(k) clearance: K043363. Product: 026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting. Reason: Exposed to freezing temperatures due to refrigerated truck malfunctions.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-04-28
Terminated: 2022-08-08
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K043363 — FRESENIUS LIBERTY CYCLERFresenius Medical Care North America·cleared 2005-03-31

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

026-20036A Liberty Drain Line, Luer Tap For patients with acute and chronic end stage renal disease going under PD in healthcare or home setting

Reason for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

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