FDA recall D-0608-2021

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

Product

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,

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-0608-2021