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U.S. Department of Health and Human Services

Class 2 Device Recall OxyMask

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  Class 2 Device Recall OxyMask see related information
Date Initiated by Firm May 25, 2021
Create Date July 24, 2021
Recall Status1 Open3, Classified
Recall Number Z-2141-2021
Recall Event ID 88103
Product Classification Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
Product OxyMask O2 Adult REF OM-1125-14
Code Information Model: OM-1125-14 Lot Number: W73887
Recalling Firm/
Manufacturer		 Southmedic, Inc.
50 Alliance Blvd
Barrie Canada
Manufacturer 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 2		 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 in Commerce 160 cases (25 units per case) in U.S.
Distribution U.S.: IL O.U.S.: N/A
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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