Skip to content
Recall Observatory FDA recall evidence

Device product

Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging Product Code: 2050-070. To evacuate air and/or fluid from the chest cavity or mediastinum.

Z-0736-2014

November 19, 2013

Class II

Product summary

Firm
Atrium Medical Corporation
Event
Event 66788
Status
Terminated
Classification
Class II
Quantity
624 units
Official record key
device-enforcement:Z-0736-2014

Official wording

Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Code information: Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers). To evacuate air and/or fluid from the chest cavity or mediastinum.

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Chest Drain tubing of of the ATS Blood recovery may leak or disconnect