Device recall
Z-2110-2018: NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part…
FDA device recall · Class II · Fresenius Medical Care Renal Therapies Group, LLC
Key facts
| Recall number (Z-number) | Z-2110-2018 |
|---|---|
| Recall event | 80101 |
| Product | NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney… |
| Product code | KPO |
| Recalling firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2020 |
| 510(k) numbers | K070177 |
| 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