BritePro Solo Single-Use Fiber Optic Laryngoscope Handle illumination failure
Flexicare Medical is recalling BritePro Solo Single-Use Fiber Optic Laryngoscope Handles because the illumination may not function as intended, which could affect their intended use.
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. Per the severity rubric, FDA Class I recalls score a minimum of 4 regardless of whether illnesses or injuries have been reported.
Plain-English summary
Flexicare Medical (Dongguan) Ltd. is recalling BritePro Solo Single-Use Fiber Optic Laryngoscope Handles (model references 040-310AU and 040-310U). The handles may not illuminate as intended.
The affected product was manufactured between July 2020 and December 2020 (lot numbers 2007xxxxx through 2012xxxxx) and distributed nationwide in the following states: Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan, Wyoming, North Carolina, and Ohio.
The FDA has classified this as a Class I recall. Users of the affected handles should discontinue use and contact Flexicare Medical for instructions regarding replacement or return.
The recalled product
- Product
- BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
- 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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