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U.S. Department of Health and Human Services

Class 2 Device Recall Hudson RCI Concha Therm Neptune Humidifier

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 Class 2 Device Recall Hudson RCI Concha Therm Neptune Humidifiersee related information
Date Initiated by FirmJune 12, 2012
Date PostedJuly 19, 2012
Recall Status1 Terminated 3 on January 28, 2014
Recall NumberZ-2036-2012
Recall Event ID 62284
510(K)NumberK063758 
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
ProductHudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
Code Information Catalog #425-00, 425-10 and 425-30.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr.
Research Triangle Park NC 27709
For Additional Information ContactMichael Taggart
919-433-4940
Manufacturer Reason
for Recall		Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment.
FDA Determined
Cause 2		Device Design
ActionTeleflex sent Urgent Medical Device Notification letters dated June 12, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to complete the enclosed Acknowledgement Form and return per the instructions provided. Once the form is received, Teleflex Medial will schedule for a technician to come to their facility and exchange the affected product. For questions call your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce14,794 each
DistributionWorldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BTT
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