FDAClass IIMay 26, 2021

Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recall: Labeling Error

Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451

Why was Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recalled?

Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.

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 #20SU03019, Exp 6/2022

Product
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Recalling firm
Fresenius Medical Care, North America
Quantity
709 cases
Distribution
USA Nationwide
Recall date
May 26, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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