FDA Device recall 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: (…
- FDA Device
- Class II
- terminated
- Published 2020-01-22
On 2020-01-22 the FDA classified a Class II recall of 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: (… by Flexicare Medical, citing 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 disengag….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0804-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-27 |
| Published | 2020-01-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Flexicare Medical |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | Part Number/Lot Number: 040-342U 180802596 I OGH 040-342U 181002320 I OGH 040-342U 181100085 I OGH 040-342U 181200025 I OGH |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2020%22
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