Device recall
Z-2161-2014: Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve…
FDA device recall · Class II · ICU Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2161-2014 |
|---|---|
| Recall event | 68971 |
| Product | Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and… |
| Product code | DRS |
| Recalling firm | ICU Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 25, 2014 |
| 510(k) numbers | K061573 |
| FEI number | 2025816 |
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