FDAClass IIMay 6, 2015

CareFusion Vital Signs LightWand Stylet. A device recall

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

Why was CareFusion Vital Signs LightWand Stylet. A device recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number 3910

Product
CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
Recalling firm
Vital Signs Colorado Inc.
Quantity
82,820
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.
Recall date
May 6, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls