Recall Z-0307-2022— Atrium Medical Corporation

Name: FDA recall Z-0307-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-22

Class II · Ongoing

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2021-10-22. It names one FDA 510(k) clearance: K043582. 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.. Reason: Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient.

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-10-22
Firm location: Merrimack, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K043582 — OCEAN CHEST DRAINAtrium Medical Corp.·cleared 2005-01-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient

Data sourced from openFDA. This site is unofficial and independent of the FDA.