Recall Z-2141-2021— Southmedic, Inc.

Name: FDA recall Z-2141-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-25

Class II · Ongoing

Class II FDA medical device recall by Southmedic, Inc., initiated 2021-05-25. FDA's recall record names no specific 510(k) clearance for this event. Product: OxyMask O2 Adult REF OM-1125-14. Reason: 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..

Recalling firm: Southmedic, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-05-25
Firm location: Barrie, N/A, Canada

Product description

OxyMask O2 Adult REF OM-1125-14

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.