Recall Z-2454-2008 ยท BSR Stylet, Tracheal Tube
Vital Signs Colorado Inc.
Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile, Vital Signs Colorado Inc., Englewood, CO. , packaged 20 per case.
| Date | Sep 21, 2008 (initiated Aug 11, 2008) |
| Status | Terminated |
| Reason | Light protector may detach from lighted stylet during intubation. |
| Root cause | Device Design |
| Action | Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement. |
| Quantity | 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 Republic, Dubai, Ecuador, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Italy, Korea, Malaysia, Me |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944729 | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE Coast Medical, Inc., Dec 21, 1994 |