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
|
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
|
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.
|
510(K) Database |
510(K)s with Product Code = NFN and Original Applicant = STEREOTAXIS, INC.
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