Recall Z-2088-2021— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-2088-2021
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: K124024. Product: The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).. 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

K124024 — APD LUER-LOCK ADAPTERFresensius Medical Care North America·cleared 2013-09-19

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

The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag equipped with a luer-lock connector to a Fresenius Automated Peritoneal Dialysis (APD) cycler set that uses the Fresenius Safe-Lock¿ connector (e.g., Liberty¿ cycler, Newton IQO cycler).

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.