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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Cook, Inc.
- Recall Initiated
- May 8, 2008
- Posted
- September 16, 2008
- Terminated
- October 21, 2008
- Recall Number
- Z-2058-2008
- Quantity
- 180
- Firm Location
- Bloomington, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The product length is declared incorrectly in mm when the unit of measurement should be cm.
Distribution
Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela.
Lot / Code Info
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..
Root Cause
Labeling Change Control
Action Taken
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.