Reported Jul 24, 2024 · Ongoing

DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange…

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 920 · Waltham, MA · 02451-1521

Is this the product you have?

  • DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
Lot codes and dates
    • 24AU03024
    • exp. date 07/31/2025
Amount recalled
183 cases

Where it was sold

  • Nationwide

Why it was recalled

This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.

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 drug enforcement) notice

Data as of Sep 19, 5:05 PM UTC

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