Device recall
Z-1147-2013: HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV…
FDA device recall · Class II · Transonic Systems Inc
Key facts
| Recall number (Z-number) | Z-1147-2013 |
|---|---|
| Recall event | 64770 |
| Product | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular… |
| Product code | DXG |
| Recalling firm | Transonic Systems Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 5, 2014 |
| 510(k) numbers | K080116 |
| FEI number | 1319030 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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