CareFusion LightWand Stylet Recalled for Sterile Packaging Breach Risk
Vital Signs Colorado is recalling LightWand Stylets because sterile packaging may be breached without visible signs, posing a patient safety risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for potential patient safety risks without confirmed adverse events.
Plain-English summary
Vital Signs Colorado (dba CareFusion) is recalling the Vital Signs LightWand Stylet, catalog numbers 3910 and 3960. This medical device is inserted into an endotracheal tube to aid in the intubation procedure. The recall involves 82,820 units distributed worldwide, including the United States, Australia, Canada, and numerous other countries.
The recall is being conducted due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use. This defect could compromise the sterility of the device, potentially exposing patients to infection risks during the intubation procedure.
Healthcare providers and facilities that have received these devices should stop using them immediately. Consumers and medical staff should check their inventory for catalog numbers 3910 and 3960 and contact Vital Signs Colorado for instructions on returning or disposing of the affected units.
The recalled product
- Product
- CareFusion Vital Signs LightWand Stylet. A device inserted into an endotracheal tube to aid in the intubation procedure.
- Manufacturer
- Vital Signs Colorado Inc.
- Category
- Medical Device — Intubation Aid
- Affected units
- 82,820
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number 3910
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Vital Signs Colorado Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Vital Signs Colorado Inc.
See all →- HighVital Signs LightWand Stylet Recalled for Sterile Packaging Breach
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