Device recall: BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10…
Class II FDA enforcement event 84367. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Flexicare Medical Ltd. started this device recall on 27 Nov 2019. The firm address in the FDA record is in Rhondda Cynon Taff. FDA put the recall in Class II. FDA event 84367 has 4 product records. The first FDA enforcement report date is 22 Jan 2020. The record gives the status Terminated, with the termination date 27 Apr 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
Recalling firm
Flexicare Medical Ltd., Rhondda Cynon Taff, United Kingdom.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0801-2020 | 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… | 1,024,890 devices | Class II | Terminated | 22 Jan 2020 |
| Z-0802-2020 | 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… | 1,024,890 devices | Class II | Terminated | 22 Jan 2020 |
| Z-0803-2020 | 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… | 1,024,890 devices | Class II | Terminated | 22 Jan 2020 |
| Z-0804-2020 | BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320 | 1,024,890 devices | Class II | Terminated | 22 Jan 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 4Median of the firm: 4
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 22 Sep 2020 | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990- Event 86484 | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-0801-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 84367. https://recallregister.com/fda/ii/84367/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
- What quantity of product is in FDA event 84367?
- The event has 4 product records. The first record gives this quantity:
1,024,890 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.