BriteBlade Pro Fiber Optic System (2019-09-12)
- Starting date:
- September 12, 2019
- Posting date:
- October 11, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-71221
Last updated: 2019-10-11
Affected Products
A. BriteBlade Pro Single-Use Fiber Optic Mac 3
B. Laryngoscope BrightBlade Pro Fibre Optic - Miller 2
C. BritePro Solo Fibre Optic Laryngoscope Handle With Batteries and Blade
Reason
User reports received that the spring/washer/bearing components in the block of the laryngoscope blade being loose and separated from the device.
Affected products
A. BriteBlade Pro Single-Use Fiber Optic Mac 3
Lot or serial number
- 181000113
- 181100001
- 181200005
Model or catalog number
- 040-713U
Companies
- Manufacturer
-
Flexicare Medical LTD.
Cynon Valley Business Park
Mountain Ash
CF45 4ER
UNITED KINGDOM
B. Laryngoscope BrightBlade Pro Fibre Optic - Miller 2
Lot or serial number
- 181000115
Model or catalog number
- 040-722U
Companies
- Manufacturer
-
Flexicare Medical LTD.
Cynon Valley Business Park
Mountain Ash
CF45 4ER
UNITED KINGDOM
C. BritePro Solo Fibre Optic Laryngoscope Handle With Batteries and Blade
Lot or serial number
- 180900072
- 180900104
- 181100097
- 181200024
Model or catalog number
- 040-333U
Companies
- Manufacturer
-
Flexicare Medical LTD.
Cynon Valley Business Park
Mountain Ash
CF45 4ER
UNITED KINGDOM