FDA-Drug2021-06-16Class III

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50

Fresenius Medical Care Holdings, Inc.
Hazard

Temperature Abuse: Product exposed to temperature outside specified limits.

Sold states
Nationwide within the United States
Affected count
25 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0604-2021

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