Exact FDA event identifier

Event 63768

9 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: November 26, 2012
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Fresenius Medical Care Holdings, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

9 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 9

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

Recall number: Z-0676-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 101,108 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

device · product 2 of 9

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Z-0677-2013

Recall number: Z-0677-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 17,782 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Code information

Lot Numbers:12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014

Distribution pattern

US Nationwide Distribution

device · product 3 of 9

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.

Z-0678-2013

Recall number: Z-0678-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 14,240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Code information

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

Distribution pattern

US Nationwide Distribution

device · product 4 of 9

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Z-0679-2013

Recall number: Z-0679-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 13,409 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Code information

Lot Numbers:12NXGF005, 12NXGF019, 12PXGF008

Distribution pattern

US Nationwide Distribution

device · product 5 of 9

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Z-0680-2013

Recall number: Z-0680-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 5 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Code information

Lot Number:12NXGF009

Distribution pattern

US Nationwide Distribution

device · product 6 of 9

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Z-0681-2013

Recall number: Z-0681-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 5,689 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Code information

Lot Numbers:12NXGF011, 12PXGF004

Distribution pattern

US Nationwide Distribution

device · product 7 of 9

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Z-0682-2013

Recall number: Z-0682-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 2493 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Code information

Lot Number:12NXGF012

Distribution pattern

US Nationwide Distribution

device · product 8 of 9

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Z-0683-2013

Recall number: Z-0683-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 670 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Code information

Lot Number:12PXGF017

Distribution pattern

US Nationwide Distribution

device · product 9 of 9

Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

Z-0684-2013

Recall number: Z-0684-2013
Initiated: November 26, 2012
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 2711 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

GranuFlo Dry Acid Concentrate may show discoloration

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

GranuFlo Dry Acid Concentrate may show discoloration

Code information

Lot Number:12PXGF002

Distribution pattern

US Nationwide Distribution