Fresenius Granuflo Dry Acid Concentrate- 2K 2 — Class III medical device recall Z-0516-2019
Terminated recall by Fresenius Medical Care Renal Therapies Group, LLC, reported 2018-12-05, distributed nationwide. Discolored powder has confirmed the presence of a foreign substance
| Recall number | Z-0516-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA, United States |
| Recall initiated | 2018-10-09 |
| Classified | 2018-11-29 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2021-08-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 4,752 |
| Lot numbers | 18ETGF005 |
| Model numbers | OFD2201-3B |
Product
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
Reason for recall
Discolored powder has confirmed the presence of a foreign substance
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-0516-2019. 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.