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Disposable Anesthesia Circuits

WESTMED, INC. · Model 9623 · UDI-DI 00709078005572

OFP Prescription

510(k) clearances

104

Adverse events (2 deaths)

Recalls

Facilities

Description

Anesthesia Circuit, Adult, 108" Expandable, Parallel Wye, B/V Filter, (2) GSE w/Cap, 2L Not made with latex bag, 10' x .038" ID m/M GSL w/Swivel elbow, 9910 series large adult mask, 10' section tubing. Yankauer Sterile

Recalls

Date	Firm	Reason
2025-03-12	Draeger, Inc.	The potential for cracks forming in the breathing circuit hose.
2025-03-12	Draeger, Inc.	The potential for cracks forming in the breathing circuit hose.
2025-03-12	Draeger, Inc.	The potential for cracks forming in the breathing circuit hose.
2025-03-12	Draeger, Inc.	The potential for cracks forming in the breathing circuit hose.
2025-03-12	Draeger, Inc.	The potential for cracks forming in the breathing circuit hose.
2021-01-29	Draeger Medical, Inc.	Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
2021-01-29	Draeger Medical, Inc.	Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
2021-01-29	Draeger Medical, Inc.	Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
2021-01-29	Draeger Medical, Inc.	Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
2020-11-11	Intersurgical Inc	The device was assembled with the incorrect exhalation port which can cause gas leakage.

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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.