Device recall
Z-1768-2019: Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with…
FDA device recall · Class I · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-1768-2019 |
|---|---|
| Recall event | 82143 |
| Product | Alaris Pump, Model 8100, with bezel mechanical assemblies manufactured with FR-110 plastic resin. The following products are affected by this recall as they are pumps or pump assemblies with bezels manufactured between April 2011 and June 2017 with the FR-110 plastic. Alaris Pump Module serviced… |
| Product code | FRN |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 26, 2023 |
| 510(k) numbers | K133532 |
| FEI number | 2016493 |
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