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Aria

Molecular Products Inc. · Model PC02-0005 · UDI-DI 00850039679124

BSF Prescription
8
510(k) clearances
78
Adverse events (1 deaths)
6
Recalls
25
Facilities

Description

CO2 Assembly, Sodasorb HMED, W-V Indicating, Aria

Recalls

DateFirmReason
2019-07-22GETINGE US SALES LLCReversed expiration and manufacturing date on the label
2013-09-19GE Healthcare, LLCGE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
2011-02-09Intersurgical IncIntersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breat
2007-07-24Datex - Ohmeda, IncElevated inspired CO2 levels related to the use of the Datex-Ohmeda GE Healthcare Disposable Multi Absorber Canister with the EZchange Module.
2003-02-12Datex-OhmedaMulti Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.
2003-02-12Datex-OhmedaMulti Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.

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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.