PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: June 16, 2021 Initiated: April 28, 2021 #D-0610-2021

Product Description

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.

Details

Units Affected
285 cases
Distribution
Nationwide within the United States
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 285 cases.
Why was this product recalled?
Temperature Abuse: Product exposed to temperature outside specified limits.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 16, 2021. Severity: Low. Recall number: D-0610-2021.