Recall Z-0484-2024— Atrium Medical Corporation

Name: FDA recall Z-0484-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-29

Class II · Ongoing

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2023-09-29. It names one FDA 510(k) clearance: K831931. Product: Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.. Reason: A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-09-29
Firm location: Merrimack, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K831931 — ATRIUM THORACIC CATHETERAtrium Medical Corp.·cleared 1983-10-04

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 Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

Reason for recall

A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.

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