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OCEAN recallZ-0316-2024 · Atrium Medical Corporation · initiated Sep 18, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Error in labeling

What the company is doing

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

Recall details

Recall number
Z-0316-2024
Status
Open, Classified
Initiated by the company
Sep 18, 2023
Posted by the FDA
Nov 16, 2023
Recalling firm
Atrium Medical Corporation
Quantity
31270 cases: 29942 cases US; 1328 cases OUS
Product code
CAC
FDA submissions
K201305
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.

Product description

Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000 DRAIN, OCEAN BRU W/AC,S

Code information (models, lots, serial numbers)

1)2002-000 DRAIN, OCEAN SINGLE W/AC,S 20650862100017 (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR 20650862100345 (3)2002-100 DRAIN, OCEAN SINGLE W/AC 20650862100093 (4)2002-300 DRAIN, OCEAN SINGLE W/S 20650862100109 (5) 2002-400 DRAIN, OCEAN SINGLE 20650862100215 (6)2012-320 DRAIN, OCEAN PEDI W/S 20650862101021 (7)2050-000 DRAIN, OCEAN BRU W/AC,S 20650862103018 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

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93149).

Sources and updates

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