FDAMay 25, 2021device
OxyMask O2 Adult REF OM-1125-14
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in a loss of device function and use of the device could result in inappropriate or a lack of oxygen delivery to the patient.
What to do
FDA enforcement status: Ongoing
Brands named
southmedic
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASouthmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020, STERILE EO2022-10-27
- FDASouthmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in various medical procedures for preparation, scraping and/or cutting of tissue.2017-11-06
- FDASouthmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2.2017-10-17
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