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U.S. Department of Health and Human Services

Class 2 Device Recall Aquapak 340 SW, 340, mL w/040 Adaptor

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 Class 2 Device Recall Aquapak 340 SW, 340, mL w/040 Adaptorsee related information
Date Initiated by FirmJune 05, 2014
Date PostedJuly 07, 2014
Recall Status1 Terminated 3 on July 02, 2015
Recall NumberZ-2009-2014
Recall Event ID 68493
510(K)NumberK833974 
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
ProductAquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor.
Code Information Product Code: 003-40J, Lot numbers: 177127, 181127, 184127, 225127, 227127, 229127, 231127, 254127, 287127, 291127, 293127, 363127, 364127, 365127, 366127, 367127, 385127, 387127, 389127, 391127, 393127, 423127, 424127, 429127, 431127, 434127, 436127, 437127 & 445127.
FEI Number 3005747797
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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