|
Class 2 Device Recall CORDIS Peripheral Steerable Guidewire |
|
Date Initiated by Firm |
July 21, 2006 |
Date Posted |
September 09, 2006 |
Recall Status1 |
Terminated 3 on November 19, 2008 |
Recall Number |
Z-1494-06 |
Recall Event ID |
35940 |
510(K)Number |
K930091
|
Product Classification |
Peripheral Steerable Guidewire - Product Code DXQ
|
Product |
CORDIS SV-8 Steerable Guidewire, 180 cm. , 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503658 |
Code Information |
70306850 70406741 70406797 70506746 |
Recalling Firm/ Manufacturer |
Cordis Corporation 14201 NW 60th Ave Miami Lakes FL 33014-2802
|
Manufacturer Reason for Recall |
Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
|
FDA Determined Cause 2 |
Other |
Action |
A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06. |
Quantity in Commerce |
6,764 |
Distribution |
World wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands |
Total Product Life Cycle |
TPLC Device Report
|
|
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 = DXQ and Original Applicant = CORDIS CORP.
|
|
|
|