—#70925

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.

FDA product code: HCG — Device, Neurovascular Embolization
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K901337
Affected lot / code info: 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.

Why it was recalled

The product length is declared incorrectly in mm when the unit of measurement should be cm.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Cook, Inc.
Address: 750 Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela.

Timeline

Recall initiated: 2008-05-08
Posted by FDA: 2008-09-16
Terminated: 2008-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70925. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.