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U.S. Department of Health and Human Services

Class 2 Device Recall Adaptor, 040 Hum

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 Class 2 Device Recall Adaptor, 040 Humsee related information
Date Initiated by FirmJune 05, 2014
Date PostedJuly 07, 2014
Recall Status1 Terminated 3 on July 02, 2015
Recall NumberZ-2015-2014
Recall Event ID 68493
510(K)NumberK833974 
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
ProductAdaptor, 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 ContactMichael 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 2
Packaging change control
ActionConsignees were notified by letter on 06/06/2014.
Quantity in Commerce7,758,650 ea. (total for all types listed)
DistributionWorldwide 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 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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