FDA recall D-0610-2021

Fresenius Medical Care Holdings, Inc. · Class III · drug

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

Reason for recall

Temperature Abuse: Product exposed to temperature outside specified limits.

Distribution

Nationwide within the United States

Key facts

Status: Terminated
Initiation date: 2021-04-28
Report date: 2021-06-16
Termination date: 2021-09-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0610-2021