PlainRecalls
FDA Devices Moderate Class II Terminated

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).

Reported: July 28, 2021 Initiated: April 28, 2021 #Z-2088-2021

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

Details

Units Affected
5 cases
Distribution
US Distribution to: TX only
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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).. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 5 cases.
Why was this product recalled?
Exposed to freezing temperatures due to refrigerated truck malfunctions
Which agency issued this recall?
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2088-2021.