BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, RE...
FDA Device Recall #Z-0803-2020 — Class II — November 27, 2019
Recall Summary
| Recall Number | Z-0803-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 27, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Flexicare Medical Ltd. |
| Location | Rhondda Cynon Taff |
| Product Type | Devices |
| Quantity | 1,024,890 devices |
Product Description
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.
Distribution Pattern
US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
Lot / Code Information
Part Number/Lot Number 040-333U 170900328 I OGH 040-333U 180800461 I OGH 040-333U 180900072 I OGH 040-333U 180900104 I OGH 040-333U 181000107 I OGH 040-333U 181100013 I OGH 040-333U 181100097 I OGH 040-333U 181200024 I OGH
Other Recalls from Flexicare Medical Ltd.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0497-2021 | Class I | ProVu Single Use Video Stylet with ET Tube, Par... | Sep 22, 2020 |
| Z-0802-2020 | Class II | BriteBlade Pro Single-se Fiber Optic Miller 2, ... | Nov 27, 2019 |
| Z-0804-2020 | Class II | BriteBlade Pro Single-Use Fiber Optic Handle an... | Nov 27, 2019 |
| Z-0801-2020 | Class II | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE... | Nov 27, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.