Atrium Medical Corporation Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
Brand
Atrium Medical Corporation
Lot Codes / Batch Numbers
UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134, (2) 4050-100N DRAIN, EXPRESS, 2020 Distribution Dates: Any product shipped on and after August 6, 2020
Products Sold
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
Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS due to Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
UPDATE: 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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026