Recall Z-0701-05 ยท DPW Flowmeter, Blood, Cardiovascular
Neoprobe Corp
Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.
| Date | Apr 13, 2005 (initiated Dec 13, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | The recalling firm notified cutomers by telepone and e mail beginning on 12/2/04. |
| Quantity | 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 34677; Peerless Medical Corp., 705 Summer Oak Dr., Ellisville, MO 63021; Rolomac International, 1836 NE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030357 | QUANTIX/OR DEVICE Cardiosonix, Ltd., Aug 20, 2003 |