FDA Medical Device Recalls (openFDA)
Southmedic, Inc.: OxyMask O2 Adult REF OM-1125-14
- Recall number
- Z-2141-2021
- Recalling firm
- Southmedic, Inc.
- Product
- OxyMask O2 Adult REF OM-1125-14
- Status
- Open, Classified
- Initiated
- 2021-05-25
- Posted
- not on file
- Terminated
- not on file
- 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.
- 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 tanger@southmedic.com.
- Quantity
- 160 cases (25 units per case) in U.S.
- Distribution
- U.S.: IL O.U.S.: N/A
- Lot, serial or model codes
- Model: OM-1125-14 Lot Number: W73887
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 3001717360
- Firm city
- Barrie
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28