Recall Z-0555-05 ยท NIQ Coronary Drug-Eluting Stent
Cordis Corporation
Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System CXSxxxxx
| Date | Feb 18, 2005 (initiated Nov 18, 2004) |
| Status | Terminated |
| Reason | Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004. |
| Root cause | Other |
| Action | The firm issued a removal of Cypher Product with Incorrect Inventory UBD Sticker letter to its customers in November 2004. The letter instructed them to return the product for credit. It also had an acknowledgement form and requested the consignees complete the acknowledgement form and fax back to Cordis. The firm intends to destroy the returned product. |
| Quantity | 80297 units |
| Distribution | Distributed nation wide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.