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.
FDA Recall Z-2057-2008 · Posted 2008-09-16
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Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeHCG
Date Initiated2008-05-08
Date Terminated2008-10-21
Product Quantity1183
Reason for Recall
The product length is declared incorrectly in mm when the unit of measurement should be cm.
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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