Recall Z-2057-2008 ยท HCG Device, Neurovascular Embolization
Cook, Inc.
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.
| Date | Sep 16, 2008 (initiated May 8, 2008) |
| Status | Terminated |
| Reason | The product length is declared incorrectly in mm when the unit of measurement should be cm. |
| Root cause | 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 | 1183 |
| Distribution | Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901337 | HILAL EMBOLIZATION MICROCOIL(TM) Cook, Inc., Nov 13, 1990 |