| Class 2 Device Recall Ocean Water Seal Chest Drains (Ocean) | |
Date Initiated by Firm | September 18, 2023 |
Date Posted | November 16, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0316-2024 |
Recall Event ID |
93149 |
510(K)Number | K201305 |
Product Classification |
Apparatus, autotransfusion - Product Code CAC
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Product | 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 |
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 |
Recalling Firm/ Manufacturer |
Atrium Medical Corporation 40 Continental Blvd Merrimack NH 03054-4332
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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 | 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 |
Quantity in Commerce | 31270 cases: 29942 cases US; 1328 cases 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 |
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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.
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510(K) Database | 510(K)s with Product Code = CAC
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