Device product

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.

Z-0676-2013

November 26, 2012

Class III

Product summary

Firm: Fresenius Medical Care Holdings, Inc.
Event: Event 63768
Status: Terminated
Classification: Class III
Quantity: 101,108 units
Official record key: device-enforcement:Z-0676-2013

Official wording

Reason: GranuFlo Dry Acid Concentrate may show discoloration

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

Distribution pattern: US Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration