Recall Z-0208-2007 ยท ITX Transducer, Ultrasonic, Diagnostic
Medtronic Vascular
Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
| Date | Nov 22, 2006 (initiated Nov 1, 2006) |
| Status | Terminated |
| Reason | Sterility may be compromised as evidenced by a loss of package integrity. |
| Root cause | Other |
| Action | On 11/1/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall. |
| Quantity | 502 |
| Distribution | Worldwide, including USA, Switzerland, France, Belgium, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031920 | CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001 Trans Vascular Incorporated, Jul 23, 2003 |