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2MM COMPACT BS WITH 3L BAG LUER ELBOW MONITORING LINE ANAES FACE MASK AND HMEF

Intersurgical Incorporated · Model 2158009 · UDI-DI 05030267160280

OFP Prescription

510(k) clearances

104

Adverse events (2 deaths)

Recalls

Facilities

Description

2MM COMPACT BREATHING SYSTEM WITH 3L BAG, LUER ELBOW, MONITORING LINE, ANAESTHETIC FACE MASK AND HMEF 3.0M

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.