Device 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.
Z-1081-2017
Product summary
- Event
- Event 75599
- Status
- Terminated
- Classification
- Class II
- Quantity
- 964,463 cases (US) 521,975 cases (OUS) in total
- Official record key
device-enforcement:Z-1081-2017
Official wording
Reason: Outer Packaging is not sterile
Code information: All Lot Numbers With Expiration Date Prior To October 2019
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, China, Columbia, Ecuador, Egypt, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Ireland, Italy, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Thailand, Tunisia, and Venezuela,
Derived failure modes
-
Unknown
Outer Packaging is not sterile