Flexicare Medical Ltd. recalls BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01)…

Recall date

November 27, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0802-2020

FDA classification

Class II

Brand / firm

Flexicare Medical Ltd.

Sold / distributed

US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 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.