Matrix2 Detachable Coils, vascular embolization device. Catalog Number: 497204SR, UPN: M003497204SR0, Catalog Number: 49
FDA device recall Z-0668-2007 · posted 2007-03-29 · Terminated
Recall details
- Recalling firm
- Boston Scientific Target
- Reason for recall
- The product may be missing the temperature indicator label on the inner pouch.
- Action taken
- The firm initiated the recall on 02/07/2007, and initially notified consignees via letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- HCG
- Quantity affected
- 57 units
- Distribution
- Worldwide including USA, Argentina, Australia, Brazil, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Ireland, Netherlands, and New Zealand.
- Date initiated
- 2007-02-07
- Date posted
- 2007-03-29
- Date terminated
- 2007-11-27
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MATRIX STRETCH RESISTANT (SR) COILS (K050700) | Boston Scientific Corp | 2005-04-15 |