Fresenius Medical Care, North America recalls Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only…
- Recall date
- April 14, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0389-2021
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care, North America
- Sold / distributed
- USA Nationwide
Why it was recalled
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
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