Z-1556-2015 Class II Terminated

Recalled by Vital Signs Colorado Inc. — Englewood, CO

Recall Details

Product Type
Devices
Report Date
May 6, 2015
Initiation Date
March 13, 2015
Termination Date
October 7, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82,820

Product Description

CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.

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 Pattern

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.

Code Information

Catalog Number 3910