IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The
FDA device recall Z-1223-06 · posted 2006-07-12 · Terminated
Recall details
- Recalling firm
- International Biophysics Corp
- Reason for recall
- Complaints received regarding the device's failure to zero out.
- Action taken
- Firm notified customers via e-mail and phone calls starting on 04/22/05.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPT
- Quantity affected
- 7,502
- Distribution
- Nationwide. Product distributed to direct accounts located in CO and MA. No foreign consignees.
- Date initiated
- 2005-04-22
- Date posted
- 2006-07-12
- Date terminated
- 2006-07-18
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) (K963703) | International Biophysics Corp. | 1998-04-08 |