Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate… — Class III medical device recall Z-0677-2013
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2013-01-23, distributed nationwide. GranuFlo Dry Acid Concentrate may show discoloration
| Recall number | Z-0677-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2012-11-26 |
| Classified | 2013-01-16 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2016-06-21 |
| Distributed | Nationwide (US) |
| Quantity | 17,782 units |
| Lot numbers | 12NXGF004, 12NXGF008, 12PXGF010, 12PXGF014 |
| Model numbers | OFD2201-3B |
Product
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.
Reason for recall
GranuFlo Dry Acid Concentrate may show discoloration
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0677-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.