BritePro Solo Mini Laryngoscope Handles Recalled Due to Illumination Defect
Flexicare Medical is recalling BritePro Solo Mini laryngoscope handles because they may not illuminate as intended. Affected units were distributed nationwide from July 2020 to December 2020.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This FDA Class I medical device recall is rated Critical per the rubric. FDA Class I classification alone is a sufficient condition for a severity score of 5, indicating a defect that could result in serious injury or serious health consequences.
Plain-English summary
The BritePro Solo Mini with Pro Miller Blade Size 1.5 (REF: 040-02-0415U) is a laryngoscope handle manufactured by Flexicare Medical (Dongguan) Ltd. Affected units have a defect that may prevent the illumination system from functioning as intended.
The recall affects laryngoscope handles with lot numbers 2007xxxxx through 2012xxxxx, manufactured between July 2020 and December 2020. These devices were distributed nationwide in Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan, Wyoming, North Carolina, and Ohio.
Users and healthcare facilities with affected devices should stop using them immediately and contact Flexicare Medical (Dongguan) Ltd. for replacement or return instructions. The FDA is monitoring this recall to ensure affected units are removed from circulation.
The recalled product
- Product
- BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
- Manufacturer
- Flexicare Medical (Dongguan) Ltd.
- Category
- Medical Device — Laryngoscopes
- 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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