Product Wiki · Recalls · U.S. FDA — Device Enforcement

BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE… — recall Z-0803-2020

U.S. FDA — Device Enforcement · United Kingdom · 2019-11-27 · Class II

As described by U.S. FDA — Device Enforcement: 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 ins

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0803-2020
Date of alert
2019-11-27
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Flexicare Medical Ltd.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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