BriteBlade Pro Single-Use Fiber Optic Mac 3 recall
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…
Why was BriteBlade Pro Single-Use Fiber Optic Mac 3 recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number/Lot Number 040-713U 180700030 I CCW 040-713U 180900099 I CCW 040-713U 180901353 I CCW 040-713U 181000110 I CCW 040-713U 181000113 I CCW 040-713U 181100001 I CCW 040-713U 181100002 I CCW 040-713U 181200005 I CCW
- 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…
- Recalling firm
- Flexicare Medical Ltd.
- Quantity
- 1,024,890 devices
- Distribution
- US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
- Recall date
- January 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)