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U.S. Department of Health and Human Services

Class 2 Device Recall Concha Therm Neptune Heated Humidifier

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  Class 2 Device Recall Concha Therm Neptune Heated Humidifier see related information
Date Initiated by Firm January 12, 2010
Date Posted March 09, 2010
Recall Status1 Terminated 3 on April 05, 2011
Recall Number Z-1040-2010
Recall Event ID 54232
510(K)Number K063758  
Product Classification humidifier - Product Code BTT
Product Teleflex Medical, Hudson RCI, Concha Therm Neptune, Heated Humidifier. Product numbers: 425-00, 425-10 and 525-30.
Code Information Product numbers: 425-00, 425-10 and 525-30, All lot and serial numbers.
Recalling Firm/
Manufacturer		 Telefelx Medical
2917 Weck Drive
Durham NC 27709
For Additional Information Contact Michael Taggart
919-433-4816
Manufacturer Reason
for Recall		 When turned on, the Neptune heater may cause an artifact on the patient's heart monitor.
FDA Determined
Cause 2		 Device Design
Action Teleflex consignees were notified via Urgent Medical Device Recall letter via next day delivery on/about 01/12/2010. They were asked to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responders on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be reworked with software upgrade and placed back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. Records will be maintained accordingly.
Quantity in Commerce 15,134 units
Distribution U.S. Canada, India, Japan, Puerto Rico, Germany, France, Italy and Ireland.
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 = TELEFLEX MEDICAL
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