Recall Z-1557-2015 ยท BSR Stylet, Tracheal Tube
Vital Signs Colorado Inc.
Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
| Date | Apr 30, 2015 (initiated Mar 13, 2015) |
| Status | Terminated |
| Reason | Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use. |
| Root cause | Packaging |
| Action | Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion). |
| Quantity | 399 |
| Distribution | Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qata |
| 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 |