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Class 2 Device Recall Amplatz Goose Neck Snare Kit |
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Date Initiated by Firm |
May 18, 2007 |
Date Posted |
July 11, 2007 |
Recall Status1 |
Terminated 3 on October 17, 2008 |
Recall Number |
Z-0992-2007 |
Recall Event ID |
38052 |
510(K)Number |
K972511
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Product Classification |
endovascular instrument - Product Code DXE
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Product |
Amplatz Goose Neck Snare Kit, 6 Fr, Lot 1650307, REF: GN3000, Use By 2009-09-01, Sterile EO ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA THE ENDOVASCULAR COMPANY.
The Snare Kit contains a pouch labeled a "Snare Catheter" and a pouch labeled "Amplatz Goose Neck Snare".
Snare Catheter |
Code Information |
Lot # 1650307 |
Recalling Firm/ Manufacturer |
Ev3, Inc 4600 Nathan Ln N Plymouth MN 55442-2890
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For Additional Information Contact |
763-398-7000
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Manufacturer Reason for Recall |
Amplatz Goose Neck Snare Kit's catheter contained in the kit may be 4 Fr instead of the intended 6 Fr.
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FDA Determined Cause 2 |
Other |
Action |
Letter May 18, 2007. |
Quantity in Commerce |
23 units |
Distribution |
Worldwide, including USA, Belgium, France, Germany, Italy, Jordan, Spain, United Kingdom, and Yemen. |
Total Product Life Cycle |
TPLC Device Report
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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 = DXE and Original Applicant = MICROVENA CORP.
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