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Curaplex

BOUND TREE MEDICAL, LLC · Model 2113-20200 · UDI-DI 00810071633256

BTR Prescription
10
510(k) clearances
19,094
Adverse events (256 deaths)
226
Recalls
132
Facilities

Description

Curaplex Select Endotracheal Tube, 10.0mm, Cuffed, w/o Stylette 10ea/bx 10bx/cs

Recalls

DateFirmReason
2025-02-13Smiths 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
2024-02-26MEDLINE INDUSTRIES, LP - NorthfieldComplaints 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
2023-05-25TELEFLEX LLCReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25TELEFLEX LLCReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25TELEFLEX LLCReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25TELEFLEX LLCReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25TELEFLEX LLCReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25TELEFLEX LLCReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25TELEFLEX LLCReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
2023-05-25TELEFLEX LLCReports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

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Data 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.