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U.S. Department of Health and Human Services

Class 3 Device Recall Cook Hilal Embolization Microcoil

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  Class 3 Device Recall Cook Hilal Embolization Microcoil see related information
Date Initiated by Firm May 08, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on October 21, 2008
Recall Number Z-2057-2008
Recall Event ID 48169
510(K)Number K901337  
Product Classification Neurovascular embolization device - Product Code HCG
Product Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.
Code Information Lots 1897765, 1902927, 1908780, 1910237, 1918237, 1921667, 1929329, 1934204, 1971324, 1971325, 1987735, 1991576, 1994124, 2000417, 2007745, 2012753x, 2012753, 2021721, 2026715, 2031205, 2034254, 2039748, 2051785, 2063422, 2066776, 2072751 and 2080653.
Recalling Firm/
Manufacturer		 Cook, Inc.
750 Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact
800-346-2686
Manufacturer Reason
for Recall		 The product length is declared incorrectly in mm when the unit of measurement should be cm.
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 1183
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
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 = HCG and Original Applicant = COOK, INC.
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