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U.S. Department of Health and Human Services

Class 2 Device Recall Aquapak 640 SW, 650 mL w/040 Adaptor

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  Class 2 Device Recall Aquapak 640 SW, 650 mL w/040 Adaptor see related information
Date Initiated by Firm June 05, 2014
Date Posted July 07, 2014
Recall Status1 Terminated 3 on July 02, 2015
Recall Number Z-2012-2014
Recall Event ID 68493
510(K)Number K833974  
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
Product Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
Code Information Product Code: 006-40, Lot numbers: 041126, 042126, 043126, 044126, 053126, 054126, 055126, 056126, 057126, 058126, 068126, 069126, 070126, 075126, 077126, 078126, 079126, 086126, 087126, 088126, 089126, 090126, 097126, 111126, 120126, 121126, 122126, 123126, 128126, 155126 & 156126.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Michael 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
Action Consignees were notified by letter on 06/06/2014.
Quantity in Commerce 7,758,650 ea. (total for all types listed)
Distribution Worldwide 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 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 = RESPIRATORY CARE, INC.
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