FDA-Device2021-07-28Class II
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).
Fresenius Medical Care Holdings, Inc.
Hazard
Exposed to freezing temperatures due to refrigerated truck malfunctions
Sold states
US Distribution to: TX only
Affected count
5 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2088-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief