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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-2004-2014
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, International, Teleflex Medical, respiratory gas humidifier adaptor .
Code Information Product Code: 400640, Lot numbers: 021126, 022126, 030126, 031126, 032126, 033126, 034126, 037126, 038126, 039126, 040126, 047126, 048126, 049126, 050126, 051126, 052126, 059126, 060126, 061126, 066126, 067126, 072126, 073126, 074126, 081126, 082126, 083126, 084126, 085126, 093126, 094126, 095126, 096126, 100126, 101126, 102126, 103126, 104126, 109126, 110126, 116126, 117126, 118126, 119126, 125126, 126126, 127126 & 151126.
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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