Recall Z-2592-2021— Atrium Medical Corporation

Name: FDA recall Z-2592-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-26

Class II · Ongoing

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2021-08-26. It names one FDA 510(k) clearance: K984496. Product: Atrium Pneumostat Chest Drain Valve, Part Number 16100. Reason: The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2021-08-26
Firm location: Merrimack, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAINAtrium Medical Corp.·cleared 1999-05-05

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 Pneumostat Chest Drain Valve, Part Number 16100

Reason for recall

The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.

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