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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 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-2003-2014
Recall Event ID 68493
510(K)Number K833974  
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
Product Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Code Information Product Code: 400340, Lot numbers: 082127, 085127, 088127, 092127, 094127, 097127, 100127, 102127, 104127, 106127, 108127, 137127, 141127, 145127, 148127, 154127, 156127, 159127, 161127, 163127, 194127, 198127, 200127, 204127, 207127, 209127, 223127, 224127, 226127, 228127, 230127, 232127, 239127, 241127, 243127, 245127, 246127, 248127, 250127, 252127, 256127, 259127, 263127, 266127, 269127, 289127, 290127, 292127, 307127, 309127, 312127, 314127, 316127, 318127, 320127, 322127, 338127, 340127, 345127, 350127, 353127, 356127, 359127, 386127, 388127, 390127, 392127, 395127, 399127, 403127, 406127, 410127, 414127, 419127, 421127, 430127, 432127, 447127, 450127, 453127, 456127, 459127, 462127, 465127, 467127, 477127, 478127, 481127, 483127, 486127, 487127, 489127, 491127, 493127, 496127, 516127, 577127 & 580127.
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 respiratory gas humidifier 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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