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Anesthesia Circuit Kit Flex (P) 1

Drägerwerk AG & Co. KGaA · Model MP02751 · UDI-DI 04048675412175

OFP
0
510(k) clearances
104
Adverse events (2 deaths)
33
Recalls
50
Facilities

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.