FDA recall Z-2088-2021

Fresenius Medical Care Holdings, Inc. · Class II · device

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 for recall

Exposed to freezing temperatures due to refrigerated truck malfunctions

Distribution

US Distribution to: TX only

Key facts

Status: Terminated
Initiation date: 2021-04-28
Report date: 2021-07-28
Termination date: 2022-08-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2088-2021