Recall Z-1223-06 ยท DPT Probe, Blood-Flow, Extravascular
International Biophysics Corp
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; packaged 10 per carton; International Biophysics Corp., Austin, TX.
| Date | Jul 12, 2006 (initiated Apr 22, 2005) |
| Status | Terminated |
| Reason | Complaints received regarding the device's failure to zero out. |
| Root cause | Other |
| Action | Firm notified customers via e-mail and phone calls starting on 04/22/05. |
| Quantity | 7,502 |
| Distribution | Nationwide. Product distributed to direct accounts located in CO and MA. No foreign consignees. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963703 | ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) International Biophysics Corp., Apr 8, 1998 |