Device recall
Z-0026-2018: Alaris Pump Module model 8100 manufactured between November 2011 and March 2012…
FDA device recall · Class II · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-0026-2018 |
|---|---|
| Recall event | 77987 |
| Product | Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The… |
| Product code | FRN |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K950419 |
| 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