PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 26, 2021 Initiated: April 14, 2021 #D-0389-2021

Product Description

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.

Details

Units Affected
709 cases
Distribution
USA Nationwide
Location
Ogden, UT

Frequently Asked Questions

What product was recalled?
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. Recalled by Fresenius Medical Care, North America. Units affected: 709 cases.
Why was this product recalled?
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 26, 2021. Severity: Moderate. Recall number: D-0389-2021.