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The issue could lead to hypercarbia (excessive CO2 in the blood) and/or hypoxemia (low levels of oxygen in the blood) due to the temporary inability to change settings. Read More
J&J is required to fully disclose the devices’ risks and place accurate information on promotional material and the “information for use” section of package inserts. Read More
“If you identify any problems with these devices, contact the manufacturer to arrange return and replacement of the devices,” the agency advised. Read More
The devicemaker is relabeling the recalled devices with two-month expiration dates, replacing the previous twelve-month shelf life expiration dates. Read More