Recall Z-0235-2023— Atrium Medical Corporation

Name: FDA recall Z-0235-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-18

Class II · Ongoing

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2022-10-18. It names one FDA 510(k) clearance: K043582. Product: Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000. Reason: Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-10-18
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

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

Reason for recall

Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients.

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