Recall Z-2456-2008 ยท BSR Stylet, Tracheal Tube
Vital Signs Colorado Inc.
Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.
| 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 | 1,121 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 |