Class 2 Device Recall Adaptor, 040 Hum

• Date Initiated by Firm: June 05, 2014
• Date Posted: July 07, 2014
• Recall Status: Terminated on July 02, 2015
• Recall Number: Z-2015-2014
• Recall Event ID: 68493
• 510(K)Number: K833974
• Product Classification: Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
• Product: Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor.
• Code Information: Product Code: 4000040, Lot number: AG14.
• Recalling Firm/ Manufacturer: Teleflex Medical; 4024 Stirrup Creek Dr; Durham NC 27703-9000
• For Additional Information Contact: Michael T. Taggart; 919-433-4829
• Manufacturer Reason for Recall: The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
• FDA Determined Cause: Packaging change control
• Action: Consignees were notified by letter on 06/06/2014.
• Quantity in Commerce: 7,758,650 ea. (total for all types listed)
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand 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 and Original Applicant = RESPIRATORY CARE, INC.