Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
FDA device recall Z-0437-05 · posted 2005-01-26 · Terminated
Recall details
- Recalling firm
- Cordis Corporation
- Reason for recall
- Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met.
- Action taken
- 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
- Status
- Terminated
- Product code
- NIQ
- Quantity affected
- 300
- Distribution
- Distributed throughout the United States.
- Date initiated
- 2005-01-12
- Date posted
- 2005-01-26
- Date terminated
- 2005-02-09
- Location
- Miami Lakes, FL
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