Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0555-05 · Posted 2005-02-18

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeNIQ
Date Initiated2004-11-18
Date Terminated2008-11-19
Product Quantity80297 units

Reason for Recall

Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.

Firm 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.

Root Cause

Other

Distribution Pattern

Distributed nation wide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑