Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0676-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: November 26, 2012

Date Posted: January 23, 2013

Recall Number: Z-0676-2013

Event ID: 63768

Reason for Recall:

GranuFlo Dry Acid Concentrate may show discoloration

Status: Terminated

Product Quantity: 101,108 units

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

Voluntary or Mandated:

Voluntary: Firm initiated