Z-0307-2022Class II

The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a...

Name: Z-0307-2022 The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a...
Creator: Atrium Medical Corporation
Published: 2021-10-22
License: https://open.fda.gov/license/

Atrium Medical Corporation / initiated 2021-10-22 / Open, Classified / root cause: labeling and UDI

FDA source

Atrium Medical Corporation began a recall of The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a... on 2021-10-22. FDA classified it as Class II and gives the reason as "Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0307-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-10-22
Posted: 2021-11-25
Recalling firm: Atrium Medical Corporation
Product: The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Atrium/Getinge issued Urgent Medical Device Correction letter issued October 22, 2021 via FedEx 2 day delivery. Letter states reason for recall, health risk and action to take: Our records indicate that you have received the Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, having the lot numbers that are affected by this correction. Please ensure that all Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, users at your facility are aware of this notice and post a copy of the Product Correction Notification on Page 4 in all inventory locations within your facility where the Atrium Ocean Chest Drains are stored. Please examine your inventory immediately to determine if you have any of the Ocean Water Seal Chest Drain, Product Code/REF number 2002-400, with the lot numbers listed in this notice. PLEASE FORWARD THIS INFORMATION TO ALL CURRENT AND POTENTIAL OCEAN CHEST DRAIN USERS WITHIN YOUR HOSPITAL / FACILITY. IF YOU ARE A DISTRIBUTOR WHO HAS SHIPPED ANY AFFECTED PRODUCTS TO CUSTOMERS, PLEASE FORWARD THIS DOCUMENT TO THEIR ATTENTION FOR APPROPRIATE ACTION. Please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 5) to acknowledge that you have received this notification. Return the completed form to Atrium/Getinge by e-mailing a scanned copy to [email protected] or by faxing the form to (877) 448-0547. f you have any questions, please contact your Atrium/Getinge representative or call 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: 87,972 drains (14,662 cases; 6 units/case)
Distribution: US Nationwide Distribution Foreign: Bahrain Belgium Brunei Darussalam Canada Colombia Ecuador Finland Italy Kuwait Libya Mauritius Mexico Netherlands Poland Portugal Russian Federation Saudi Arabia Spain United Arab Emirates United Kingdom of Great Britain and Northern Ireland
Product codes and lots: Product Code/REF Number 2002-400; Lot codes: 441533, 443300, 443608, 443629, 444473, 445527, 448966, 449683, 450899, 450900, 451270, 451988, 452177, 452814, 454577, 455871, 458264, 458604, 459198, 459642, 462192, 462194, 464075, 464076, 465037, 466247, 469921, 470627, 471651,471703, 472562, 472785 and 473725. UDI Code: 00650862100211

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0307-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0307-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-01	2021-11-25

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)