FDA Device recall Z-0678-2013
Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usa…
- FDA Device
- Class III
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class III recall of Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usa… by Fresenius Medical Care Holdings, citing granuFlo Dry Acid Concentrate may show discoloration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0678-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-11-26 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
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.
Reason
GranuFlo Dry Acid Concentrate may show discoloration
Identifiers
| code_info | Lot Numbers:12NXGF002, 12NXGF014, 12PXGF006, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0678-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.