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Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Cata...

FDA Recall #Z-0676-2013 — Class III — November 26, 2012

Recall #Z-0676-2013 Date: November 26, 2012 Classification: Class III Status: Terminated

Product Description

Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Reason for Recall

GranuFlo Dry Acid Concentrate may show discoloration

Recalling Firm

Fresenius Medical Care Holdings, Inc. — Waltham, MA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

101,108 units

Distribution

US Nationwide Distribution

Code Information

Lot Numbers: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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