FDA Device Intelligence
Home › COOK INCORPORATED › Cook

Cook

COOK INCORPORATED · Model G57621 · UDI-DI 00827002576216

BTR Prescription
1
510(k) clearances
19,094
Adverse events (256 deaths)
226
Recalls
132
Facilities

Description

Cook Airway Exchange Catheter with Rapi-Fit Adapters

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.

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 docs
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.