Z-0235-2023Class II

Atrium Ocean Wet Suction Water Seal Chest Drain-

Name: Z-0235-2023 Atrium Ocean Wet Suction Water Seal Chest Drain-
Creator: Atrium Medical Corporation
Published: 2022-10-18
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2022-10-18 / Open, Classified

FDA source

Atrium Medical Corporation began a recall of Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000 on 2022-10-18. FDA classified it as Class II and gives the reason as "Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0235-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-18
Posted: 2022-11-15
Recalling firm: Atrium Medical Corporation
Product: Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.
FDA 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 in commerce: 24 units (4cases/6)
Distribution: US Nationwide distribution in the state of VA.
Product codes and lots: UDI-DI: 20650862100017 - case / 00650862100013- each Lot Number: 472326, 473226

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0235-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0235-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-15

Product code KDQ

K043582Class IIOcean Chest DrainAtrium Medical Corp. / cleared 2005-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)