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Terminated

Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.

FDA Recall Z-0437-05 · Posted 2005-01-26

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeNIQ
Date Initiated2005-01-12
Date Terminated2005-02-09
Product Quantity300

Reason for Recall

Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.

Firm Action

A withdrawal letter is in the process of being hand-delivered to accounts that received this lot, by a Cordis sales representative. Any remaining units from this lot are being removed, and returned to Cordis. The returned units will be scrapped. An Acknowledgement Form is being signed indicating that the account was informed, and documenting whether there is any remaining product from this lot. The withdrawal action was initiated January 12, 2005.

Root Cause

Other

Distribution Pattern

Distributed throughout the United States.

Official Source

View FDA Recall →

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

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