Vital Signs LightWand Stylet Recalled for Sterile Packaging Breach
Vital Signs Colorado is recalling LightWand Stylets because sterile packaging may be breached without visible signs, posing a patient safety risk.
What this means for you
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 medical device with a potential patient safety risk (sterile packaging breach) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960. The recall is due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
The affected devices are Introduction Packs, which are inserted into an endotracheal tube to aid in the intubation procedure. The recall covers 399 units that were distributed worldwide, including the United States, Australia, Canada, and numerous other countries.
Healthcare providers should stop using these devices and contact the manufacturer for further instructions regarding the recall.
The recalled product
- Product
- Introduction Pack. 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
- 399
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 3960
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.
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