Device recall
Z-0008-2020: ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw…
FDA device recall · Class II · The Metrix Company
Key facts
| Recall number (Z-number) | Z-0008-2020 |
|---|---|
| Recall event | 83509 |
| Product | ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of… |
| Product code | KPE |
| Recalling firm | The Metrix Company |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K960581 |
| FEI number | 1000117446 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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