Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
FDA Recall Z-0235-2023 · Posted 2022-11-15
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Recalling FirmAtrium Medical Corporation
Recall StatusOpen, Classified
Product CodeKDQ
Date Initiated2022-10-18
Product Quantity24 units (4cases/6)
Reason for Recall
Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
Firm 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 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).
Root Cause
Storage
Distribution Pattern
US Nationwide distribution in the state of VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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