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Class 3 Device Recall Cook Hilal Embolization Microcoil |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
May 08, 2008 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on October 21, 2008 |
Recall Number |
Z-2058-2008 |
Recall Event ID |
48169 |
510(K)Number |
K901337
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Product Classification |
Neurovascular embolization device - Product Code HCG
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Product |
Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. |
Code Information |
Lots F2100451, F2102327, F2102038, F2102833, F2109137, F2112851, F21114679, F2122527, F2125284, F2126416, F2136920, F2141567, F2142403, F2142578, F2143038, F2146823, F2146882, F2147969, F2150692, F2159335, F2159263, F2161387, F2172446, F2188499, F2189353, F2203609, F2204861, F2207480, F2213136, F2213468 and F2215748.. |
Recalling Firm/ Manufacturer |
Cook, Inc. 750 Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact |
800-346-2686
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Manufacturer Reason for Recall |
The product length is declared incorrectly in mm when the unit of measurement should be cm.
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FDA Determined Cause 2 |
Labeling Change Control |
Action |
Consignees were notified via recall letter dated 5/9/08 that the firm would replace product on hand. Distributors were requested to notify their customers of the recall.
If you have questions, contact Customer Relations Department at 800-346-2686. |
Quantity in Commerce |
180 |
Distribution |
Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela. |
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 = HCG and Original Applicant = COOK, INC.
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