Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
- Company
- Atrium Medical Corporation
- Recall Initiated
- October 18, 2022
- Posted
- November 15, 2022
- Recall Number
- Z-0235-2023
- Quantity
- 24 units (4cases/6)
- Firm Location
- Merrimack, NH
Reason for Recall
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
Distribution
US Nationwide distribution in the state of VA.
Lot / Code Info
UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226
Root Cause
Storage
Action Taken
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 form on page 3 to acknowledge that you have received this notification. If you have any questions, please contact your Atrium/Getinge representative or call the 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).