CLASS II Device recall · Reported 6 May 2015 · FDA Enforcement Report

Introduction Pack recalled by Vital Signs Colorado

Vital Signs Colorado is recalling Introduction Pack, distributed nationwide in the US. The recall was initiated on 13 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number 3960

Quantity recalled399

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1557-2015
FDA event ID: 70753
Recalling firm: Vital Signs Colorado, Englewood, CO
Classification: Class II
Status: Terminated
Recall initiated: 13 Mar 2015
FDA classified: 30 Apr 2015
Reported: 6 May 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

13 Mar 2015	Recall initiated by company
30 Apr 2015	Classified by FDA	+48 days
6 May 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.

Where it was distributed

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.

Nationwide

Questions about this recall

Is Introduction Pack recalled?

Yes. Vital Signs Colorado recalled Introduction Pack on 13 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1557-2015.

Why was it recalled?

Which lots are affected?

Catalog Number 3960

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Vital Signs Colorado

All 4

Reported	Class	Recall	Company	Reason	Where
6 May 2015Device	CLASS II	CareFusion Vital Signs LightWand Stylet recalled by Vital Signs Colorado	Vital Signs Colorado	Sterility	Nationwide
29 Jan 2014Device	CLASS II	Vital Signs Anesthesia Circuits The Ventilator Circuit is recalled	Vital Signs Colorado	Processing Deviation	Nationwide
28 Nov 2012Device	CLASS II	Vital Signs Disposable General Purpose Temperature Probe recalled	Vital Signs Colorado	Temperature Abuse	Nationwide

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