Recall Z-1082-2017— Atrium Medical Corporation

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2016-11-29, terminated 2020-09-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain with in-line connector and suction control stopcock - 2 patient lines connected by one Y connector 2052-300 Ocean Double Blood Recovery drain with suction control stopcock, no in-line connector - 2 patient lines connected by one Y connector Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.. Reason: Outer Packaging is not sterile.

Recalling firm

Atrium Medical Corporation

Classification

Class II

Status

Terminated

Initiated

2016-11-29

Terminated

2020-09-29

Firm location

Hudson, NH, United States

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