FDAClass IIIDecember 5, 2018

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg recall

Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis

Why was Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg recalled?

Discolored powder has confirmed the presence of a foreign substance

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 code: 18ETGF010 18HTGF002 18HTGF003 18HTGF007 18HTGF011 18HTGF013 18HTGF016 18JTGF005 18JTGF010 18JTGF012 18KTGF001 18KTGF011

Product
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Recalling firm
Fresenius Medical Care Renal Therapies Group, LLC
Quantity
92225
Distribution
Distribution US nationwide and Mexico
Recall date
December 5, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
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