Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged
FDA device recall Z-2454-2008 · posted 2008-09-21 · Terminated
Recall details
- Recalling firm
- Vital Signs Colorado Inc.
- Reason for recall
- Light protector may detach from lighted stylet during intubation.
- Action taken
- Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- BSR
- Quantity affected
- 55,560 pieces
- Distribution
- Worldwide including states of CA, OH, MD, NC, TX and VA facilities in GA, IN, MS, NC, NJ, NM, NY, and VA. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Dominican Republ
- Date initiated
- 2008-08-11
- Date posted
- 2008-09-21
- Date terminated
- 2011-01-10
- Location
- Englewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE (K944729) | Coast Medical, Inc. | 1994-12-21 |