Class 2 Device Recall The ConchaTherm Neptune Heated Humidifier

• Date Initiated by Firm: April 01, 2015
• Date Posted: April 30, 2015
• Recall Status: Open, Classified
• Recall Number: Z-1558-2015
• Recall Event ID: 70895
• 510(K)Number: K131912
• Product Classification: Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
• Product: Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only.
• Code Information: Material number: 425-00, Serial numbers: 611040101, 611040106, 611040107, 611040108, 611040109, 611040110, 611040111, 611040113, 611040114, 611040117, 611040118, 611040119, 611040120, 611050001, 611050002, 611050004, 611050005, 611050008, 611050010, 611050013, 611050015, 611050019, 611050021, 611050022, 611050023, 611050024, 611050027, 611050031, 611050032, 611050033, 611050038, 611050039, 611050040, 611050041, 611050042, 611050045, 611050047, 611050049, 611050050, 611050051, 611050052, 611050053, 611050055, 611050058, 611050059, 611050060, 611050061, 611050063, 611050064, 611050065, 611050066, 611050067, 611050068, 611050070, 611050072, 611050073, 611050074, 611050076, 611050077, 611050082, 611050084, 611050085, 611050086, 611050091, 611050094, 611050098, 611050099, 611050101, 611050103, 611050104, 611050106, 611050107, 611050109, 611050110, 611050115, 611050116, 611050119, 611050120, 611050121, 611050122, 611050125, 611050126, 611050127, 611050128, 611050129, 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613050242, 613050243, 613050244, 613050245, 613050246, 613050247, 613050248, 613050249, 613050250, 613050251, 613050253, 613050254, 613050255, 613050256, 613050257, 613050258, 613050259, 613050260, 613050261, 613050262, 613050263, 613050264, 613050265, 613050266, 613050267, 613050268, 613050269, 613050270, 613050271, 613050272, 613050273, 613050274, 613050275, 613050276, 613050277, 613050278, 613050279, 613050280, 613050281, 613050282, 613050283, 613050284, 613050285, 613050286, 613050287, 613050288, 613050289, 613050290, 613050291, 613050293, 613050294, 613050295, 613050296, 613050297, 613050298, 613050299, 613050300, Material Number 425-10, Serial Numbers: 612050001, 612050002, 612050003, 612050004, 612050005, 612050006, 612050007, 612050008, 612050009, 612050010, 612050011, 612050012, 612050013, 612050014, 612050015, 612050016, 612050018, 612050019, 612050020, 612050021, 612050022, 612050023, 612050024, 612050025, 612050027, 612050028, 612050029, 612050030, 612060001, 612060002, 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613020010, 613020011, 613020012, 613020014, 613020015, 613020018, 613020019, 613020020, 613020021, 613020022, 613020023, 613020024, 613020025, 613020027, 613020029, 613020030, 613020032, 613020033, 613030001, 613030002, 613030003, 613030004, 613030005, 613030006, 613030007, 613030008, 613030009, 613030010, 613030011, 613030012, 613030013, 613030014, 613030015, 613030016, 613030017, 613030018, 613030019, 613030020, 613030021, 613030022, 613030023, 613030024, 613030025, 613030026, 613030027, 613030028, 613030029, 613030030, 613030031, 613030032, 613030033, 613030034, 613030035, 613030036, 613030037, 613030038, 612040001, 613040002, 613040003, 613040004, 613040005, 613040006, 613040007, 613040008, 613040009, 613040010, 613040011, 613040012, 613040013, 613040014, 613040015, 613040016, 613040017, 613040018, 613040019, 613040020, 613040021, 613040022, 613040023, 613040024, 613040025, 613040026, 613040027, 613040028, 613040029, 613040030, 613040031, 613040032, 613040033, 613040034, 613040035, 613040036, 613040037, 613040038, 613040039, 613040040, 613040041, 613040042, 613040043, 613040044, 613040045, 613040046, 613040047, 613040048, 613040049, 613040050, 613040051, 613040052, 613050001, 613050002, 613050005, 613060001, 613060002, 613060003, 613060004, 613060005, 613060006, 613060008, 613060009, 613060010, 613060011, 613060012, 613060014, 613060016, 613060017, 613060018, 613060019, 613060020; Material number: 425-40, Serial numbers: 611110001, 611110003, 611110004, 611110006, 611110007, 611110009, 611110010, 611110011, 611110012, 611110015, 611110016, 611110017, 611110018, 611110019, 611110020, 611110021, 611110022, 611110023, 611110024, 611110025, 611110026, 611110028, 611110029, 611110030, 611110031, 611110032, 611110033, 611110034, 611110035, 611110036, 611110039, 611110040, 611110041, 611110042, 611110043, 611110044, 611110045, 611110046, 611110047, 611110048, 611110049, 611110050, 611110051, 611110052, 611110053, 611110055, 611110056, 611110057, 611110058, 611110059, 611110061, 611110062, 611110063, 611110064, 611110065, 611110066, 611110067, 611110068, 611110069, 611110070, 611110071, 611110072, 611110073, 611110074, 611110076, 611110077, 611110078, 611110079, 611110080, 611110081, 611110082, 611110083, 611110085, 611110086, 611110087, 611110088, 611110089, 611110090, 611110091, 611110092, 611110093, 611110094, 611110096, 611110097, 611110098 and 611110099.
• Recalling Firm/ Manufacturer: Teleflex Medical; 2917 Weck Dr; Research Triangle Park NC 27709-0186
• For Additional Information Contact: Tara Torres; 601-378-0131
• Manufacturer Reason for Recall: Customer complaints were received of power to the unit ceasing and the display going blank.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Teleflex sent an Urgent - Medical Device Notification letter dated April 1, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were informed that Teleflex Medical would exchange all of the potentially impacted units in the field with the Neptune¿ Heated Humidifier with ConchaSmart" Technology. In the meantime, they were instructed to continue to follow hospital and departmental protocol regarding the regular monitoring of the patient and the product during treatment. If the unit display is blank, replace it with another unit and call Teleflex for an immediate replacement. A Recall Acknowledgement Form was attached to be completed, scanned and returned to Teleflex Medical to document receipt of this Notification. Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
• Quantity in Commerce: 7,228 units
• Distribution: US Nationwide and Internationally to the countries of: Belgium and Japan
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BTT and Original Applicant = TELEFLEX, INC.