Device recall
Z-0837-2011: Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B…
FDA device recall · Class I · B Braun Medical, Inc
Key facts
| Recall number (Z-number) | Z-0837-2011 |
|---|---|
| Recall event | 57099 |
| Product | Outlook 400ES Safety Infusion System, Model Number 621-400ES. For use with B. Braun Medical Inc. Horizon Pump IV Sets |
| Product code | FRN |
| Recalling firm | B Braun Medical, Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 29, 2014 |
| 510(k) numbers | K011975, K994375 |
| FEI number | 1641965 |
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