Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A

FDA device recall Z-0317-2024 · posted 2023-11-16 · Open, Classified

Recall details

Recalling firm

Atrium Medical Corporation

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

Action taken

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

Root cause

Error in labeling

Status

Open, Classified

Product code

CAC

Quantity affected

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, Fran

Date initiated

2023-09-18

Date posted

2023-11-16

Location

Merrimack, NH

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