FDA-Drug2024-01-10Class II
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Fresenius Medical Care Holdings, Inc.
Hazard
Lack of Sterility Assurance
Sold states
Nationwide within the United States
Affected count
69,590 bags
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Medical Care NA Waltham, MA 02451, NDC 49230-206-62.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0218-2024Don't want to check this manually?
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