FDA Device recall Z-0517-2019
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
- FDA Device
- Class III
- terminated
- Published 2018-12-05
On 2018-12-05 the FDA classified a Class III recall of Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis by Fresenius Medical Care Renal Therapies Group, citing discolored powder has confirmed the presence of a foreign substance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0517-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-10-09 |
| Published | 2018-12-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fresenius Medical Care Renal Therapies Group |
| Distribution | US |
Product
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
Reason
Discolored powder has confirmed the presence of a foreign substance
Identifiers
| code_info | Lot code: 18ETGF010 18HTGF002 18HTGF003 18HTGF007 18HTGF011 18HTGF013 18HTGF016 18JTGF005 18JTGF010 18JTGF012 18KTGF001 18KTGF011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0517-2019%22
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