Recall Z-0801-2020— Flexicare Medical Ltd.
Class II · Terminated
Class II FDA medical device recall by Flexicare Medical Ltd., initiated 2019-11-27, terminated 2021-04-27. FDA's recall record names no specific 510(k) clearance for this event. 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 oral cavity to manipulate the tongue and/or the epiglottis.. Reason: 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..
- Recalling firm
- Flexicare Medical Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-27
- Terminated
- 2021-04-27
- Firm location
- Rhondda Cynon Taff, United Kingdom
Product description
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 oral cavity to manipulate the tongue and/or the epiglottis.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.