Recall Z-1081-2017— Atrium Medical Corporation
Class II · Terminated
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 Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of drain 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
Product description
Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction control stopcock, ¿ in. Tubing, Sims and Pedi connector in bag on back of drain 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 for recall
Outer Packaging is not sterile
Data sourced from openFDA. This site is unofficial and independent of the FDA.