Class 2 Device Recall Atrium

• Date Initiated by Firm: November 29, 2016
• Create Date: January 24, 2017
• Recall Status: Terminated on September 29, 2020
• Recall Number: Z-1081-2017
• Recall Event ID: 75599
• Product Classification: Chest drainage kit - Product Code PAD
• 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.
• Code Information: All Lot Numbers With Expiration Date Prior To October 2019
• Recalling Firm/ Manufacturer: Atrium Medical Corporation; 5 Wentworth Dr; Hudson NH 03051-4929
• For Additional Information Contact: Megan Indeglia ; 603-880-1433
• Manufacturer Reason for Recall: Outer Packaging is not sterile
• FDA Determined Cause: Package design/selection
• Action: Atrium Medical issued recall letter on 11/29/16 via two-day express mail delivery advising users: of the problem, updated instructions for use; the new Warning Label applied to the packaging; and requesting to post the warning label near all Atrium chest drain product inventory. A Field Notification Reply Form acknowledging receipt of the Field Notification was requested to be completed and returned. Questions contact Atrium/Maquet/Getinge chest drainage representative or Atrium Customer Service at 1-800-528-7486 (603-880-1433), Monday through Friday between 8:00 am and 5:00 pm (EST).
• Quantity in Commerce: 964,463 cases (US) 521,975 cases (OUS) in total
• Distribution: 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,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.