• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

  • Print
  • Share
  • E-mail

Product Detail

Product Description Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
Recall Number Z-0743-2014
Classification Class II
Code Info Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)
Product Distributed Qty 1,944 units
Reason For Recall Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Event Detail

Event Id 66788
Product Type Devices
Status Ongoing
Recalling Firm Atrium Medical Corporation
City Hudson
State NH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.