BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
Enforcement
- Recall Number
- Z-0802-2020
- Event ID
- 84367
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Flexicare Medical Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 22, 2020
- Initiation Date
- November 27, 2019
- Classification Date
- January 13, 2020
- Termination Date
- April 27, 2021
- Address
- Cynon Valley Business Park, Mountain Ash, Rhondda Cynon Taff, N/A, United Kingdom
Description
BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
Part Number/Lot Number 040-722U 181000115 I CCW 040-722U 181001520 I CCW 040-722U 181200006 I CCW 040-722U 181202055 I CCW 040-722U 190100006 I CCW
US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
1,024,890 devices