Device recall
Z-0007-2012: Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and…
FDA device recall · Class II · B Braun Medical, Inc
Key facts
| Recall number (Z-number) | Z-0007-2012 |
|---|---|
| Recall event | 59847 |
| Product | Outlook ES Safety Infusion System, Model 621-100ES, 621-200ES, 621-300ES, and 621-400ES B. Braun Medical Inc., 1601 Wallace Drive, Suite 150, Carrollton, TX 75006 The Outlook ES pump is intended for use with B. Braun Medical Inc., Horizon Pump IV Sets to regulate the flow of primary and secondary… |
| Product code | FRN |
| Recalling firm | B Braun Medical, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 7, 2015 |
| 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