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Open, Classified

Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000

FDA Recall Z-0235-2023 · Posted 2022-11-15

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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