Britepro Solo Laryngoscope Handles May Fail to Illuminate Properly
Flexicare Medical is recalling certain Britepro Solo laryngoscope handles that may fail to illuminate properly. Affected devices were distributed nationwide from July through December 2020.
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: This is an FDA Class I recall, which requires a minimum severity rating of Severe per the rubric. No illnesses or injuries have been reported, but the illumination failure could prevent proper visualization during critical intubation procedures.
Plain-English summary
Flexicare Medical is recalling certain Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handles (Reference 040-03-0000U) due to a potential illumination defect. The handles may not illuminate as intended, which could affect visibility during intubation procedures.
The recalled devices were manufactured between July 2020 and December 2020, with lot codes ranging from 2007xxxxx to 2012xxxxx. Distribution was US Nationwide in the states of Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan, Wyoming, North Carolina, and Ohio.
Flexicare Medical and the FDA have not received reports of illness or injury associated with this recall. Hospitals and medical facilities that have received affected units should check their lot numbers against the recall information and stop using any devices that match the affected lot codes. Users should contact Flexicare Medical for further instructions regarding replacement or disposal.
The recalled product
- Product
- Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
- 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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