FDA recall D-0389-2021

Product

Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451

Reason for recall

Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2021-04-14

Report date

2021-05-26

Termination date

2022-04-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ogden, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2021