BritePro Solo mini handles and blades may not illuminate as intended
BritePro Solo Single-Use Fiber Optic Mini Handles and Blades in Macintosh and Miller sizes are being recalled because the handles may not illuminate as intended.
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 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 Single-Use Fiber Optic Mini Handle and Blade is being recalled across REFs 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve), 040-02-0140U (Mac 4) and 040-02-0400U (Miller 00), together with the further REFs listed in the recall notice. 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 REFs and lot range above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040
- 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.
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