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.
- Company
- Atrium Medical Corporation
- Recall Initiated
- October 22, 2021
- Recall Number
- Z-0307-2022
- Quantity
- 87,972 drains (14,662 cases; 6 units/case)
- Firm Location
- Merrimack, NH
Reason for Recall
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
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
Lot / Code Info
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
Root Cause
Labeling design
Action Taken
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).