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Recall Observatory FDA recall evidence

Device product

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

Z-1556-2015

March 13, 2015

Class II

Product summary

Firm
Vital Signs Colorado Inc.
Event
Event 70753
Status
Terminated
Classification
Class II
Quantity
82,820
Official record key
device-enforcement:Z-1556-2015

Official wording

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.

Code information: Catalog Number 3910

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.