Z-1556-2015Class II

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

Name: Z-1556-2015 CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation...
Creator: Vital Signs Colorado Inc.
Published: 2015-03-13
License: https://open.fda.gov/license/

Vital Signs Colorado, Inc. / initiated 2015-03-13 / Terminated / root cause: packaging

FDA source

Vital Signs Colorado Inc. began a recall of CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure on 2015-03-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1556-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Posted: 2015-04-30
Terminated: 2015-10-07
Recalling firm: Vital Signs Colorado, Inc.
Product: CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
Product code: BSR Stylet, Tracheal Tube
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: 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).
Quantity in commerce: 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.
Product codes and lots: Catalog Number 3910

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1556-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1556-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-30
Z-1557-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-30

Product code BSR

K944729Class IStylet Sheath with Locking Cap and Reusable Battery Operated Light SourceCoast Medical, Inc. / cleared 1994-12-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)