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Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49

Recalled June 16, 2021 · FDA recall D-0610-2021 · Fresenius Medical Care Holdings

Hazard
Temperature Abuse: Product exposed to temperature outside specified limits. · FDA Class III
Units
285 cases
Sold at
Nationwide within the United States

Description

Temperature Abuse: Product exposed to temperature outside specified limits.

Product
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Fresenius Medical Care Holdings, Inc. recalls DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49 | RecallWatchUSA