Recall Z-0307-2022 ยท KDQ Bottle, Collection, Vacuum
Atrium Medical Corporation
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.
| Date | Oct 22, 2021 |
| Status | Open, Classified |
| Reason | Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient |
| Root cause | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043582 | OCEAN CHEST DRAIN Atrium Medical Corp., Jan 21, 2005 |