Device recall
Z-1223-06: IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component…
FDA device recall · Class II · International Biophysics Corp
Key facts
| Recall number (Z-number) | Z-1223-06 |
|---|---|
| Recall event | 35704 |
| Product | IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N… |
| Product code | DPT |
| Recalling firm | International Biophysics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 18, 2006 |
| 510(k) numbers | K963703 |
| FEI number | 1000117854 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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