Home › O-Two Medical Technologies Inc › Rescue Breather

Rescue Breather

O-Two Medical Technologies Inc · Model 01PV1503W · UDI-DI 07540195056510

KGB Prescription

510(k) clearances

159

Adverse events (6 deaths)

Recalls

151

Facilities

Description

Rescue Breather® CPR Pocket Ventilator provides the rescuer with a safe and effective means to perform life saving expired air resuscitation while offering maximum protection from the potential risks of disease transfer for both the patient and the rescuer.The Rescue Breather® CPR Pocket Ventilator comes standard with a disposable Low-Resistance Clear One-Way-Valve with built-in 3M Filtrete® Filter, protected Oxygen inlet, adjustable Head Strap, pair of “Latex Free” Nitrile Gloves, Instructions leaflet and Clam Shell Carrying Case.

Recalls

Date	Firm	Reason
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2004-07-12	Medex Inc	The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
2004-07-12	Medex Inc	The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.