Device recall
Z-2185-2012: Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is…
FDA device recall · Class I · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-2185-2012 |
|---|---|
| Recall event | 55121 |
| Product | Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as… |
| Product code | FRN |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 26, 2015 |
| 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