Reported Jul 28, 2021 · Terminated

The Fresenius APD Luer-Lock Adapter, Catalog number 050-95018, is designed to connect a peritoneal dialysis bag…

Fresenius Medical Care Holdings, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 950 · Waltham, MA · 02451-1521

Is this the product you have?

  • 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).
Lot codes and dates
  • Lot Number20LR08111
  • UDI(01)00840861100811
Amount recalled
5 cases

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Where it was sold

Why it was recalled

Exposed to freezing temperatures due to refrigerated truck malfunctions

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 8, 2022 · Data as of Sep 19, 4:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.