PlainRecalls
FDA Drug Low Class III Terminated

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,

Reported: June 16, 2021 Initiated: April 28, 2021 #D-0608-2021

Product Description

DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,

Reason for Recall

Temperature Abuse: Product exposed to temperature outside specified limits.

Details

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

Frequently Asked Questions

What product was recalled?
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set, packaged in a) 2500 mL (NDC 49230-209-94) and b) 2000mL, packs of 5 (NDC 49230-209-92) Fresenius Medical Care NA, Waltham, MA 02451,. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 39 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-0608-2021.