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U.S. Department of Health and Human Services

Class 2 Device Recall Oasis Dry Suction Water Seal Chest Drains (Oasis)

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  Class 2 Device Recall Oasis Dry Suction Water Seal Chest Drains (Oasis) see related information
Date Initiated by Firm September 18, 2023
Date Posted November 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-0317-2024
Recall Event ID 93149
510(K)Number K043140  K201305  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product Oasis Dry Suction Water Seal Chest Drains (Oasis):
(1)3600-100 DRAIN, OASIS SINGLE W/AC;
(2)3612-100 DRAIN, OASIS PEDI A/C;
(3)3650-100 DRAIN, OASIS BRU W/AC;
Code Information UDI-DI: (1)3600-100 DRAIN, OASIS SINGLE W/AC 20650862110016; (2)3612-100 DRAIN, OASIS PEDI A/C 20650862111013; (3) 3650-100 DRAIN, OASIS BRU W/AC 20650862113017 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information Contact SAME
603-880-1433
Manufacturer Reason
for Recall		 Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
FDA Determined
Cause 2		 Error in labeling
Action Atrium/Getinge issued URGENT MEDICAL DEVICE Correction letter on September 18, 2023 via FedEx 2 day delivery on or before, September 20, 2023. Letter states reason for recall, health risk and action to take: facility can continue use of the device. No devices need to be returned. " Please ensure that all Atrium Ocean, Oasis, or Express Single Collection Chest Drain users at your facility are aware of this Safety Notice and post a copy of the Notice on Page 4 in all inventory locations within your facility where the devices are stored Notification of the release of the updated IFU containing the new Precaution will be communicated to all customers upon release, including reminder the Notice on Page 4 may be removed upon the facility s receipt of product with the updated IFU. " Please forward this information to all current and potential Atrium Ocean, Oasis, or Express Single Collection Chest Drain users within your hospital / facility. " If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. " Whether or not your facilty has affected product(s) listed in this notice, please complete and sign the attached MEDICAL DEVICE- CORRECTION RESPONSE FORM (Page 5) to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a scanned copy to YConnector2023.atrium@getinge.com or by faxing the form to 1(800)-599-8364. Atrium /Getinge has identified the cause of the issue and has initiated updates to the Atrium Oasis and Express Chest Drain Instructions for Use (IFU). The Atrium Ocean Chest Drain IFU will not be updated as the product has been discontinued. If you have any questions, please contact your Atrium/Getinge representative or call the Atrium/Getinge Customer Support at 1-(888)-943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in Commerce 471037 cases US; 638 case OUS
Distribution Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Republic of Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan, Peru, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan Province of China, Thailand Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uruguay.
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.
510(K) Database 510(K)s with Product Code = CAC and Original Applicant = ATRIUM MEDICAL CORP.
510(K)s with Product Code = CAC and Original Applicant = Atrium Medical Corporation
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