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U.S. Department of Health and Human Services

Class 2 Device Recall Ocean Water Seal Chest Drain, Model 2002400

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  Class 2 Device Recall Ocean Water Seal Chest Drain, Model 2002400 see related information
Date Initiated by Firm October 22, 2021
Create Date November 25, 2021
Recall Status1 Open3, Classified
Recall Number Z-0307-2022
Recall Event ID 88923
510(K)Number K043582  
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.
Code Information Product Code/REF Number 2002-400; Lot codes: 441533, 443300, 443608, 443629, 444473, 445527, 448966, 449683, 450899, 450900, 451270, 451988, 452177, 452814, 454577, 455871, 458264, 458604, 459198, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651,471703, 472562, 472785 and 473725.  UDI Code: 00650862100211
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
40 Continental Blvd
Merrimack NH 03054-4332
For Additional Information Contact SAME
603-880-1433
Manufacturer Reason
for Recall		 Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
FDA Determined
Cause 2		 Labeling design
Action Atrium/Getinge issued Urgent Medical Device Correction letter issued October 22, 2021 via FedEx 2 day delivery. Letter states reason for recall, health risk and action to take: Our records indicate that you have received the Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, having the lot numbers that are affected by this correction. Please ensure that all Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, users at your facility are aware of this notice and post a copy of the Product Correction Notification on Page 4 in all inventory locations within your facility where the Atrium Ocean Chest Drains are stored. Please examine your inventory immediately to determine if you have any of the Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, with the lot numbers listed in this notice. PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL OCEAN CHEST DRAIN USERS WITHIN YOUR HOSPITAL / FACILITY. IF YOU ARE A DISTRIBUTOR WHO HAS SHIPPED ANY AFFECTED PRODUCTS TO CUSTOMERS, PLEASE FORWARD THIS DOCUMENT TO THEIR ATTENTION FOR APPROPRIATE ACTION. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification. Return the completed form to Atrium/Getinge by e-mailing a scanned copy to oceandrain.atrium@getinge.com or by faxing the form to (877) 448-0547. f you have any questions, please contact your Atrium/Getinge representative or call Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
Quantity in Commerce 87,972 drains (14,662 cases; 6 units/case)
Distribution US Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada Colombia Ecuador Finland Italy Kuwait Libya Mauritius Mexico Netherlands Poland Portugal Russian Federation Saudi Arabia Spain United Arab Emirates United Kingdom of Great Britain and Northern Ireland
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KDQ and Original Applicant = ATRIUM MEDICAL CORP.
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