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Drug FDA Class II Ongoing Quality

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, 1-800-323-5

Fresenius Medical Care Holdings, Inc. Published Jul 24, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Fresenius Medical Care Holdings, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

DELFLEX · 183 cases

NDC: 49230-206, 49230-209, 49230-212, 49230-206-92, 49230-206-94, 49230-206-95, 49230-209-92, 49230-209-94, 49230-209-95, 49230-212-92, 49230-212-94, 49230-212-95
Code info: 24AU03024, exp. date 07/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 18, 2024
  2. Published
    Jul 24, 2024
Recall number
D-0608-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.