Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.
This recall has been terminated (originally issued April 30, 2015).
- Company
- Vital Signs Colorado Inc.
- Recall Initiated
- March 13, 2015
- Posted
- April 30, 2015
- Terminated
- October 7, 2015
- Recall Number
- Z-1557-2015
- Quantity
- 399
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 Qatar.
Lot / Code Info
Catalog Number 3960
Root Cause
Packaging
Action Taken
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).