Flexicare Medical Ltd. Recall: BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac
Flexicare Medical Ltd. Recall: BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Flexicare Medical Ltd.; Product: BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Steri
| Recalling firm | Flexicare Medical Ltd. |
|---|---|
| Product | BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072 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. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK |
| Recall initiated | 20191127 |
| Recall number | Z-0803-2020 |
| Category | device |
| Country | United Kingdom |
$29/mo
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