Reported Jan 22, 2020 · Terminated
BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U,…
Flexicare Medical Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flexicare Medical Ltd. · Cynon Valley Business Park, Mountain Ash · Rhondda Cynon Taff · N/A
Is this the product you have?
- BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only
- REF
040-342USterile EOQty 10
- UDI(01)15055788724053(17)230901(10)181002320
- Lot codes and dates
- Part Number/Lot Number040-342U 180802596 I OGH 040-342U 181002320 I OGH 040-342U 181100085 I OGH 040-342U 181200025 I OGH
- Amount recalled
- 1,024,890 devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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