Device recall
Z-0679-2013: Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K…
FDA device recall · Class III · Fresenius Medical Care Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-0679-2013 |
|---|---|
| Recall event | 63768 |
| Product | 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. |
| Product code | KPO |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 21, 2016 |
| 510(k) numbers | K030497 |
| FEI number | 3001451489 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database