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STATVAC II Oxygen powered Aspirator

O-Two Medical Technologies Inc · Model 01AS9500 · UDI-DI 07540195053014

BTA Prescription

510(k) clearances

968

Adverse events (29 deaths)

Recalls

Facilities

Description

The O-Two Statvac® II Aspirator is capable of effectively suctioning out excessive quantities of fluid/particles from a patient’s oro/naso pharynx. The lightweight aspirator is designed to be attached to any 50 psi DISS outlet. The ON/OFF shuttle provides for fast actuation of the aspirator in an emergency. Continuous suction is provided by simply depressing the “GREEN” shuttle control. The aspiration can be quickly and easily turned off by depressing the “RED” shuttle control button on the opposite side of the aspirator.

Recalls

Date	Firm	Reason
2023-08-23	R A Medical Services	Inadequate documentation of acceptance activity
2021-11-16	Ohio Medical Corporation	Increase in premature device failures
2020-12-02	Medela AG Medical Technology	Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".
2018-08-14	Ohio Medical Corporation	The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in l
2016-02-08	MicroAire Surgical Instruments, LLC	Complaints that the cannula bent/broke during surgery.
2010-11-08	Ohio Medical Corporation	The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery insi
2010-05-10	Ohio Medical Corporation	Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during u
2010-05-10	Ohio Medical Corporation	Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during u
2008-08-07	Smith And Nephew, Inc. Wound Management Division	External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery.
2008-04-25	Medtronic Neuromodulation	The Medela Vario 18 Vacuum Pump used with the Medtronic Bravo pH Monitoring System. The Vacuum Pump is used to provide the vacuum pressure during Capsule attachment. Some Medela

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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.