Z-2141-2021Class II

OxyMask O2 Adult REF OM-1125-14

Name: Z-2141-2021 OxyMask O2 Adult REF OM-1125-14
Creator: Southmedic, Inc.
Published: 2021-05-25
License: https://open.fda.gov/license/

Southmedic Inc. / initiated 2021-05-25 / Open, Classified / root cause: manufacturing process

FDA source

Southmedic, Inc. began a recall of OxyMask O2 Adult REF OM-1125-14 on 2021-05-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2141-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-25
Posted: 2021-07-24
Recalling firm: Southmedic Inc.
Product: OxyMask O2 Adult REF OM-1125-14
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 05/25/2021, the firm sent an "Urgent Medical Device Recall" Notice Letter via email with a follow-up telephone conversation on 06/03/2021 to inform customer that the Recalling Firm has become aware of the potential for disconnection of the oxygen tubing at the mask's elbow. This disconnection may result in a loss of device function leading to a lack of oxygen delivery to the patient. Customers are instructed to take the following actions: 1. Review your inventory and confirm whether you are still in possession of the impacted product. 2. Complete the Confirmation Form provided and fax the form to the attention of Tish Whitehead at 705-728-9537. 3. Please return any of the impacted products you may have in stock to the following address: Southmedic Inc., 364 St Vincent Street, Unit #15 Barrie, ON L4M 4A5 4. Please write RGA# OM112514MAY2021 on the outside of the package. Product may be returned using UPS Account # 5652381. For any questions - contact the VP Quality and Regulatory Affairs at (800) 463-7146 ext 342 or by email at [email protected].
Quantity in commerce: 160 cases (25 units per case) in U.S.
Distribution: U.S.: IL O.U.S.: N/A
Product codes and lots: Model: OM-1125-14 Lot Number: W73887

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2141-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2141-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-04	2021-07-23

Product code CCK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)