Recall Z-1556-05 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
Cordis Corporation
Product is a Powerflex P3 Dialation Catheter. Product is labeled in part: ''***POWERFLEX P3***Cordis***a Johnson and Johnson company***ENDOVASCULAR***STERILE EO***Cordis Europa N.V., 9301 LJ Roden, The Netherlands***''
| Date | Sep 21, 2005 (initiated May 11, 2005) |
| Status | Terminated |
| Reason | During competitive product testing, wire movement difficulties were observed in Powerflex P3 units. Due to the possibility of user inconvenience, Cordis is recalling the six affected lots of Powerflex P3. There is no patient impact. |
| Root cause | Other |
| Action | Recalled by letter and Cordis Sales Representatives interfacing directly with US consignees. |
| Quantity | 48 units |
| Distribution | Distributed to 35 consignees throughout the US and other consignees in 11 countries worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.