Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-elut
FDA device recall Z-0555-05 · posted 2005-02-18 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- NIQ
- Quantity affected
- 80297 units
- Distribution
- Distributed nation wide.
- Date initiated
- 2004-11-18
- Date posted
- 2005-02-18
- Date terminated
- 2008-11-19
- Location
- Miami Lakes, FL
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