Adult Sotair Device
Safebvm Corp. · Model 00 · UDI-DI 00860006979607
Description
The Sotair™ device is a universal safety accessory device that is compatible with all manual resuscitators and airway interfaces that have standard ISO 5356-1:2015 15/22 mm connections. The device connects in-line between the bag and the mask, endotracheal tube or other applicable adjunct. In use, when the provider squeezes the bag too forcefully, crossing the maximum flow-limiting safety threshold of air delivered (~ 55 liters-per-minute), the Sotair device’s valve will instantaneously close. The valve remains closed as long as the user is maintaining the force of an unsafe squeeze on the bag. Once the provider releases the grip on the resuscitator bag, the valve will rapidly return to its resting position allowing the user to resume resuscitation at a safe flow.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-08 | Datex-Ohmeda Inc | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration se |
| 2025-07-09 | Ambu Inc. | Potential for the manometer port being blocked rendering the manometer non-functional. |
| 2025-05-01 | SunMed Holdings, LLC | Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there wou |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
| 2024-01-10 | Vyaire Medical | Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ven |
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