Recall Z-0804-2020— 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 Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320. 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 Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320
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.