FDA recall D-0218-2024

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

Product

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.

Reason for recall

Lack of Sterility Assurance

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2023-12-28
Report date: 2024-01-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0218-2024