BritePro Solo Mini Laryngoscope Handles May Not Illuminate During Use
Flexicare Medical is recalling BritePro Solo Mini laryngoscope handles because the illumination may fail. These surgical devices, critical for safe intubation, might not light up during procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification establishes a minimum severity of 4. The failure to illuminate during intubation is a functional defect of a critical airway management device that could prevent proper airway visualization and cause serious patient harm.
Plain-English summary
Flexicare Medical (Dongguan) Ltd. is recalling BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handles (REF: 040-309U) due to a defect that may prevent the devices from illuminating as intended. The recalled devices have lot codes from 2007xxxxx to 2012xxxxx, manufactured between July 2020 and December 2020.
Laryngoscope handles are critical medical devices used during intubation procedures to visualize the patient's airway. If the illumination fails during use, the clinician cannot properly visualize the airway, potentially compromising the safety of an intubation procedure and risking serious patient harm. The FDA has classified this as a Class I recall.
The recalled devices were distributed nationwide in the following states: Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan, Wyoming, North Carolina, and Ohio. Healthcare providers and medical professionals in possession of these devices should cease use immediately and contact Flexicare Medical or their medical device supplier for instructions regarding return, replacement, or credit of the recalled devices.
The recalled product
- Product
- BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
- Manufacturer
- Flexicare Medical (Dongguan) Ltd.
- Hazard
- illumination-failure
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)
- Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Distribution
Distributed nationwide across the United States.
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