FDA-Drug2021-06-16Class III
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
Fresenius Medical Care Holdings, Inc.
Hazard
Temperature Abuse: Product exposed to temperature outside specified limits.
Sold states
Nationwide within the United States
Affected count
4 cases
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL, packs of 5, Rx only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-212-92
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0609-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief