Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0678-2013)

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 Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B 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-0678-2013

Event ID: 63768

Reason for Recall:

GranuFlo Dry Acid Concentrate may show discoloration

Status: Terminated

Product Quantity: 14,240 units

Code Information:

Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006,

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated