Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
Flexicare Medical is recalling BriteBlade Pro laryngoscope blades because internal components may become loose and enter the patient's mouth.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where loose components could enter the patient's oral cavity, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Flexicare Medical Ltd. is recalling approximately 1,024,890 units of the BriteBlade Pro Single-Use Fiber Optic Mac 3 laryngoscope blades. The recall affects specific lots identified by part number 040-713U and various lot numbers, including 180700030, 180900099, 180901353, 181000110, 181000113, 181100001, 181100002, and 181200005. These devices are intended for direct vision laryngoscopy to view the vocal cords and glottis.
The recall was initiated after the firm received reports that the spring, washer, and bearing components within the laryngoscope blade block can become loose and separate from the device. If the blade is disengaged over a patient's mouth, these loose parts could potentially enter the oral cavity. This issue may cause a delay in the medical procedure while the loose parts are retrieved.
The affected devices were distributed nationwide in the United States and in several international locations, including Australia, Canada, China, the Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, the Netherlands, Panama, Romania, Russia, South Korea, the UAE, and the UK. Healthcare providers and facilities should stop using the affected lots and contact Flexicare Medical for further instructions on the recall.
The recalled product
- Product
- BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the…
- Manufacturer
- Flexicare Medical Ltd.
- Category
- Medical Device — Laryngoscope
- Affected units
- 1,024,890
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Flexicare Medical 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 4 products in this recall →Related recalls
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FDA (Devices) · 2020-12-02
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
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