Device recall
Z-1428-2009: Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike…
FDA device recall · Class II · B. Braun Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1428-2009 |
|---|---|
| Recall event | 51869 |
| Product | Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For use with the Horizon NXT Pump, and OutLook Safety Infusion System. |
| Product code | FPA |
| Recalling firm | B. Braun Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2009 |
| 510(k) numbers | K904518, K955585 |
| FEI number | 2523676 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1,000+ 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