Summary
The FDA issued a Class II for OxyMask O2 Adult REF OM-1125-14 by Southmedic, Inc.. 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.
Details
Source
Device Recall
External ID
Z-2141-2021
Action Date
2021-08-04
Status
Ongoing
Category
device
Product Description
OxyMask O2 Adult REF OM-1125-14
Lot/Code Info: Model: OM-1125-14 Lot Number: W73887
Quantity Affected: 160 cases (25 units per case) in U.S.
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.
Distribution
U.S.: IL O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-25
Company
Barrie, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Southmedic, Inc. has 3 FDA actions in our database, including 2 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Southmedic, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Southmedic, Inc. have FDA actions?
Southmedic, Inc. has 3 FDA actions in our database, including 2 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2141-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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