Device evidence

device-recall:cfres:150878

Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) 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.

Official recall number

Z-1085-2017

Evidence summary

Product code: PAD
Recall status: Terminated
Event initiated: November 29, 2016
Root cause: Package design/selection
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-1085-2017