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U.S. Department of Health and Human Services

Class 2 Device Recall Express Dry Seal Chest Drains (Express)

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 Class 2 Device Recall Express Dry Seal Chest Drains (Express)see related information
Date Initiated by FirmSeptember 18, 2023
Date PostedNovember 16, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0318-2024
Recall Event ID 93149
510(K)NumberK043140 K201305 
Product Classification Apparatus, autotransfusion - Product Code CAC
ProductExpress Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Code Information UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141 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 ContactSAME
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
ActionUPDATE: April 2024. Getinge issued letter Getinge Thoracic Drainage Labeling Updates: New Instructions for Use Precaution for Oasis and Express Chest Drains to existing customers April 17, 2024 (US) and April 23, 2024 (OUS). As a result, inventory will be a mix of the current IFU and new IFU with the updated precaution statement until the current IFU-containing products are depleted. Reminder: In September 2023, Getinge initiated Medical Device Correction 3011175548-08/18/2023-001-C which requested your facility to post a copy of the Notice on Page 4 of the notification in all inventory locations where the devices are stored. Since the updated IFU now contains this new Precaution, the Page 4 Notice may be removed from all inventory locations once all affected product with expiry labeled March 7th, 2024 and earlier has been depleted. Please contact your Getinge Inside Sales Representative should you need an electronic copy of the new Instructions for Use. 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 custom
Quantity in Commerce48339 cases: 48148 cases US; 193 cases OUS
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = CAC
510(K)s with Product Code = CAC
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