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Parker Flex-Tip
SALTER LABS · Model H-PFNC-40 · UDI-DI 10749065031402
BTR
Prescription
10
510(k) clearances
19,170
Adverse events (256 deaths)
227
Recalls
132
Facilities
Description
Endotracheal Tube, Preformed Nasal, High Volume Low Pressure, Cuffed (PFNC), Parker, 4.0mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-31 | WELL LEAD MEDICAL CO. LTD | The 6Fr suction catheter could not pass through the samples smoothly. |
| 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. |
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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.