Recall Z-0486-2024— Atrium Medical Corporation

Name: FDA recall Z-0486-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-05

Class II · Ongoing

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2023-09-05. It names one FDA 510(k) clearance: K043582. Product: Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY. Reason: Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-09-05
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 Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY

Reason for recall

Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.

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