Recall Z-0235-2023
Atrium Medical Corporation · initiated October 18, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Codes / lots: UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226
Reason for recall
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA-determined 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).
Details
- Recall number
- Z-0235-2023
- Initiated
- October 18, 2022
- Posted by FDA
- November 15, 2022
- Product code
- KDQ – Bottle, Collection, Vacuum
- Quantity
- 24 units (4cases/6)
- Distribution
- US Nationwide distribution in the state of VA.
- Recalling firm
- Atrium Medical Corporation, Merrimack, NH