Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.
FDA device recall Z-0701-05 · posted 2005-04-13 · Terminated
Recall details
- Recalling firm
- Neoprobe Corp
- Reason for recall
- The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.
- Action taken
- The recalling firm notified cutomers by telepone and e mail beginning on 12/2/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- DPW
- Quantity affected
- 19 devices
- Distribution
- Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman St., Santa Ana, CA 92705; Ilex Medical, 370 Cypress Creek Circle, Olsmar, FL 3467
- Date initiated
- 2004-12-13
- Date posted
- 2005-04-13
- Date terminated
- 2007-07-21
- Location
- Dublin, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QUANTIX/OR DEVICE (K030357) | Cardiosonix, Ltd. | 2003-08-20 |