FDAClass IIAugust 4, 2021

OxyMask O2 Adult recall

OxyMask O2 Adult REF OM-1125-14

Why was OxyMask O2 Adult recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: OM-1125-14 Lot Number: W73887

Product
OxyMask O2 Adult REF OM-1125-14
Recalling firm
Southmedic, Inc.
Quantity
160 cases (25 units per case) in U.S.
Distribution
U.S.: IL O.U.S.: N/A
Recall date
August 4, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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