FDAClass IIIJune 16, 2021

DELFELX Peritoneal Dialysis Solution with 4.25% recall

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

Why was DELFELX Peritoneal Dialysis Solution with 4.25% recalled?

Temperature Abuse: Product exposed to temperature outside specified limits.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 21AK01022, Exp. date July 2022; 20SK01022, Exp. date June 2022

Product
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC…
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
49 cases
Distribution
Nationwide within the United States
Recall date
June 16, 2021
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls