LigaSure Atlas Laparoscopic Vessel Sealer/Divider
FDA device recall Z-0772-06 · posted 2006-04-19 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.
- Action taken
- Consignees were notified by letter on 01/27/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 124,000 units domestic, 126,000 units internationally.
- Distribution
- Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan
- Date initiated
- 2006-01-27
- Date posted
- 2006-04-19
- Date terminated
- 2008-08-15
- Location
- Boulder, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 (K010013) | Valleylab, Inc. | 2001-03-26 |