FDA Medical Device Recalls (openFDA)
Atrium Medical Corporation: Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
- Recall number
- Z-0235-2023
- Recalling firm
- Atrium Medical Corporation
- Product
- Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
- Status
- Open, Classified
- Initiated
- 2022-10-18
- Posted
- 2022-11-15
- Terminated
- not on file
- 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 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).
- Quantity
- 24 units (4cases/6)
- Distribution
- US Nationwide distribution in the state of VA.
- Lot, serial or model codes
- UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226
- 510(k) numbers
- ["K043582"]
- PMA numbers
- not on file
- Product code
- KDQ
- Firm FEI
- 3011175548
- Firm city
- Merrimack
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28