Device recall
Z-1612-2012: Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x, 55…
FDA device recall · Class II · Fresenius Medical Care Holdings, Inc.
Key facts
| Recall number (Z-number) | Z-1612-2012 |
|---|---|
| Recall event | 61418 |
| Product | Fresenius Medical Naturalyte Acid Concentrate for bicarbonate Dialysis 45x , 55 gallons (208.2 Liters) Cat. No. 13-2251-0. NaturaLyte liquid acid concentrate is formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates. |
| Product code | KPO |
| Recalling firm | Fresenius Medical Care Holdings, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2014 |
| 510(k) numbers | K981043 |
| 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