Atrium Medical Corporation: Medical Device Recall in 2023 - (Recall #: Z-0484-2024)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Product Classification:
Class II
Date Initiated: September 29, 2023
Date Posted: December 13, 2023
Recall Number: Z-0484-2024
Event ID: 93408
Reason for Recall:
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Status: Ongoing
Product Quantity: 2460 units (246 cases, 10 units/case)
Code Information:
UDI-DI: 00650862150360, lot ME234686, expiration date 2023-02-24.
Distribution Pattern:
US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
Voluntary or Mandated:
Voluntary: Firm initiated