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Ace Aerosol Cloud Enhancer

Mylan Specialty L.P. · Model 49502-203-01 · UDI-DI 00349502203015

CAF Prescription

510(k) clearances

3,267

Adverse events (43 deaths)

Recalls

189

Facilities

Description

The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery.

Recalls

Date	Firm	Reason
2023-08-04	MEDLINE INDUSTRIES, LP - Northfield	Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
2021-03-31	Smiths Medical ASD Inc.	The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
2018-08-29	SANRAI INTERNATIONAL LLC	The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.
2017-09-05	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
2017-09-05	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
2017-09-05	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
2017-09-05	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
2017-09-05	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
2017-09-05	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
2017-09-05	Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company	Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

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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.