Recall Z-0235-2023 ยท KDQ Bottle, Collection, Vacuum
Atrium Medical Corporation
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
| Date | Nov 15, 2022 (initiated Oct 18, 2022) |
| Status | Open, Classified |
| Reason | Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients. |
| Root cause | Storage |
| Action | Atrium/ Getinge issued Urgent Medical Device Removal on 10/18/21 via email with Delivery and Read receipt. Letter states reason for recall, health risk and action to take: Our records indicate that McKesson has received the Atrium Ocean Wet Suction Water Seal Chest Drains from the lot listed on Page 1. " Please examine your inventory and confirm that you have no remaining Atrium Ocean Wet Suction Water Seal Chest Drain 2002-000 with the REF/LOT number listed in this notice. Please return any product that may be affected under this Field Action. " Please respond to this email using the response |
| Quantity | 24 units (4cases/6) |
| Distribution | US Nationwide distribution in the state of VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043582 | OCEAN CHEST DRAIN Atrium Medical Corp., Jan 21, 2005 |