Recall Z-1494-06 ยท DXQ Blood Pressure Cuff
Cordis Corporation
CORDIS SV-8 Steerable Guidewire, 180 cm. , 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503658
| Date | Sep 9, 2006 (initiated Jul 21, 2006) |
| Status | Terminated |
| Reason | Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation. |
| Root cause | Other |
| Action | A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06. |
| Quantity | 6,764 |
| Distribution | World wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930091 | CORDIS REFLEX STEERABLE GUIDEWIRE Cordis Corp., Apr 7, 1993 |