BritePro Solo mini Miller blade handles may not illuminate as intended
BritePro Solo Mini with Pro Miller Blade Size 1.5 is being recalled because the laryngoscope handles may not illuminate as intended.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The BritePro Solo Mini with Pro Miller Blade Size 1.5, REF 040-02-0415U, is being recalled. The source does not state a quantity. Affected lots run from 2007xxxxx to 2012xxxxx, covering July 2020 to December 2020.
The stated reason is that the laryngoscope handles may not illuminate as intended. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States, including Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan and Wyoming. The handles and blades are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the REF and lot range above and follow the instructions issued by the manufacturer.
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 — Laryngoscope
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
Part of a larger recall action
This product is one of 6 recalled by Flexicare Medical (Dongguan) Ltd. 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 6 products in this recall →Related recalls
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