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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-2008-2014
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, French, Teleflex Medical, respiratory gas humidifier adaptor.
Code Information Product Code: 003-40F, Lot numbers: 046127, 049127, 052127, 053127, 055127, 056127, 058127, 059127, 061127, 062127, 065127, 066127, 068127, 069127, 071127, 072127, 074127, 211127, 213127, 215127, 217127, 233127, 236127, 238127, 244127, 247127, 249127, 251127, 253127, 257127, 260127, 261127, 264127, 267127, 270127, 272127, 274127, 276127, 288127, 300127, 304127, 313127, 315127, 317127, 333127, 334127, 336127, 339127, 341127, 343127, 368127, 371127, 376127, 379127, 382127, 396127, 398127, 401127, 405127, 433127, 435127, 438127, 464127, 466127, 468127, 470127, 471127, 473127, 474127, 485127, 488127, 490127, 492127, 495127, 513127 & 518127.
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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