Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude
FDA device recall Z-2058-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Cook, Inc.
- Reason for recall
- The product length is declared incorrectly in mm when the unit of measurement should be cm.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- HCG
- Quantity affected
- 180
- Distribution
- Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela.
- Date initiated
- 2008-05-08
- Date posted
- 2008-09-16
- Date terminated
- 2008-10-21
- Location
- Bloomington, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HILAL EMBOLIZATION MICROCOIL(TM) (K901337) | Cook, Inc. | 1990-11-13 |