Reported Jan 22, 2020 · Terminated
BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10,…
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 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.
- Lot codes and dates
- 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
- 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.
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