Date Initiated by Firm | January 27, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on October 31, 2005 |
Recall Number | Z-0595-04 |
Recall Event ID |
28254 |
510(K)Number | K021363 |
Product Classification |
unknown device name - Product Code NFN
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Product | Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001263-1 |
Code Information |
Lot 0212-2027 |
Recalling Firm/ Manufacturer |
Stereotaxis Inc 4041 Forest Park Ave Saint Louis MO 63108-3213
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For Additional Information Contact | Robert W. Calllahan 314-615-6923 |
Manufacturer Reason for Recall | The magnet at the end of the guidewire could break off. |
FDA Determined Cause 2 | Other |
Action | Consignees were sent a notice dated January 27, 2004. The notice requested that consignees stop using the product and stated that a firm representative would contact the consignees. The firm''s representatives have retrieved all of the product at the consignees. |
Quantity in Commerce | 44 guidewires |
Distribution | The product was shipped to consignees in Iowa, Massachusetts, Missouri, Oklahoma, and Texas in the United States and to consignees in Germany and The Netherlands. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NFN
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