Recall Z-2141-2021

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.

FDA-determined cause: Nonconforming Material/Component

Action taken

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.