Recall Z-0434-05 ยท DQY Catheter, Percutaneous
Cordis Corporation
VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter.
| Date | Jan 26, 2005 (initiated Dec 7, 2004) |
| Status | Terminated |
| Reason | Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming wire during the guiding catheter manufacturing process. |
| Root cause | Other |
| Action | Packets containing the Customer Letter and Acknowledgement Form for each domestic consignee were sent by overnight delivery to the appropriate Cordis Endovascular sales representatives. The letter is being hand-delivered to each initial domestic consignee by the Cordis Endovascular sales representative. Any remaining units at the account will be removed from the shelf and returned to Cordis. The account will be asked to sign the Acknowledgement Form. |
| Quantity | 153 units |
| Distribution | Distributed to 57 accounts throughout the United States and three international accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021593 | MODIFICATION TO ENVOY AND VISTA BRITE TIP Cordis Corp., Jun 13, 2002 |