Device recall
Z-1739-2022: Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified…
FDA device recall · Class II · Isopure Corp
Key facts
| Recall number (Z-number) | Z-1739-2022 |
|---|---|
| Recall event | 90739 |
| Product | Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS… |
| Product code | KPO |
| Recalling firm | Isopure Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 31, 2024 |
| 510(k) numbers | K120005 |
| FEI number | 3013942511 |
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