Class 2 Device Recall Hudson RCI Humidifier Adaptor, 040

• Date Initiated by Firm: January 14, 2015
• Date Posted: February 12, 2015
• Recall Status: Terminated on December 04, 2017
• Recall Number: Z-1096-2015
• Recall Event ID: 70280
• 510(K)Number: K833974
• Product Classification: Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
• Product: AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
• Code Information: Product Code: 001-40J, Lot numbers: 001139 & 003139.
• Recalling Firm/ Manufacturer: Teleflex Medical; 2917 Weck Dr; Research Triangle Park NC 27709-0186
• For Additional Information Contact: Tara Torres; 610-378-0131
• Manufacturer Reason for Recall: The packages may contain foreign material (black particles).
• FDA Determined Cause: Material/Component Contamination
• Action: Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
• Quantity in Commerce: 15,779,607 units
• Distribution: Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
• 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.

• 510(K) Database: 510(K)s with Product Code = BTT