Home › FUJI SYSTEMS CORPORATION › ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF
ENDOTRACHEAL TUBE, WIRE REINFORCED, WITH CUFF
FUJI SYSTEMS CORPORATION · Model I.D. 6.5MM (FR.28), 400MM LONG TYPE · UDI-DI 04544050081801
10
510(k) clearances
19,170
Adverse events (256 deaths)
226
Recalls
132
Facilities
Description
Endotracheal Tubes are intended for oral intubation and are indicated for use in airway management and other suitable medical application.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-13 | Smiths Medical ASD, Inc. | Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulm |
| 2024-02-26 | MEDLINE INDUSTRIES, LP - Northfield | Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inf |
| 2023-05-25 | TELEFLEX LLC | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| 2023-05-25 | TELEFLEX LLC | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| 2023-05-25 | TELEFLEX LLC | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| 2023-05-25 | TELEFLEX LLC | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| 2023-05-25 | TELEFLEX LLC | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| 2023-05-25 | TELEFLEX LLC | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| 2023-05-25 | TELEFLEX LLC | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
| 2023-05-25 | TELEFLEX LLC | Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.