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Disposable Anesthesia Circuits

WESTMED, INC. · Model 9323 · UDI-DI 00709078011115

OFP Prescription
0
510(k) clearances
105
Adverse events (2 deaths)
33
Recalls
50
Facilities

Description

Anesthesia Circuit, Pediatric, 60", GSE, Parallel WYE, 1L not made with latex breathing bag, Angled HMEF, 48" Dropline

Recalls

DateFirmReason
2025-03-12Draeger, Inc.The potential for cracks forming in the breathing circuit hose.
2025-03-12Draeger, Inc.The potential for cracks forming in the breathing circuit hose.
2025-03-12Draeger, Inc.The potential for cracks forming in the breathing circuit hose.
2025-03-12Draeger, Inc.The potential for cracks forming in the breathing circuit hose.
2025-03-12Draeger, Inc.The potential for cracks forming in the breathing circuit hose.
2021-01-29Draeger 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.
2021-01-29Draeger 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.
2021-01-29Draeger 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.
2021-01-29Draeger 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.
2020-11-11Intersurgical IncThe 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.