FDA-Drug2021-06-16Class III
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
Fresenius Medical Care Holdings, Inc.
Hazard
Temperature Abuse: Product exposed to temperature outside specified limits.
Sold states
Nationwide within the United States
Affected count
39 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0608-2021Don't want to check this manually?
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