FDA Drug Low Class III Terminated

DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92

Reported: June 16, 2021 Initiated: April 28, 2021 #D-0607-2021

Product Description

Reason for Recall

Temperature Abuse: Product exposed to temperature outside specified limits.

Details

Recalling Firm: Fresenius Medical Care Holdings, Inc.
Units Affected: 5 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 and attached stay safe Exchange set, 2000 mL Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-206-92. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 5 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-0607-2021.