FDA Drug Low Class III Terminated

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50

Reported: June 16, 2021 Initiated: April 28, 2021 #D-0606-2021

Product Description

Reason for Recall

Temperature Abuse: Product exposed to temperature outside specified limits.

Details

Recalling Firm: Fresenius Medical Care Holdings, Inc.
Units Affected: 49 cases
Distribution: Nationwide within the United States
Location: Waltham, MA

Frequently Asked Questions

What product was recalled? ▼

DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 49 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-0606-2021.