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

• Date Initiated by Firm: June 05, 2014
• Date Posted: July 07, 2014
• Recall Status: Terminated on July 02, 2015
• Recall Number: Z-2006-2014
• 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, Teleflex Medical, respiratory gas humidifier adaptor.
• Code Information: Product Code: 003-40, Lot numbers: 088137, 093127, 095127, 096127, 098127, 099127, 101127, 103127, 105127, 107127, 111127, 112127, 113127, 114127, 115127, 116127, 117127, 118127, 119127, 120127, 121127, 122127, 123127, 124127, 125127, 126127, 127127, 128127, 129127, 130127, 131127, 132127, 133127, 134127, 135127, 136127, 138127, 140127, 143127, 144127, 146127, 147127, 149127, 150127, 151127, 152127, 153127, 158127, 160127, 162127, 164127, 165127, 166127, 167127, 168127, 169127, 170127, 171127, 172127, 173127, 175127, 176127, 178127, 179127, 180127, 182127, 183127, 185127, 186127, 187127, 188127, 189127, 190127, 191127, 192127, 193127, 196127, 197127, 199127, 201127, 202127, 203127, 205127, 206127, 208127, 210127, 212127, 214127, 216127, 218127, 219127, 220127, 221127, 234127, 235127 , 237127, 240127, 242127, 258127, 262127, 265127, 268127, 271127, 273127, 275127, 278127, 279127, 280127, 281127, 282127, 283127, 284127, 285127, 286127, 294127, 295127, 296127, 297127, 298127, 299127, 301127, 302127, 303127, 305127, 306127, 308127, 310127, 311127, 319127, 321127, 323127, 324127, 325127, 326127, 327127, 328127, 329127, 330127, 331127, 332127, 342127, 344127, 346127, 348127, 349127, 351127, 352127, 354127, 355127, 357127, 358127, 360127, 361127, 369127, 370127, 372127, 373127, 374127, 375127, 377127, 378127, 380127, 381127, 383127, 394127, 397127, 400127, 402127, 407127, 408127, 409127, 411127, 412127, 416127, 418127, 420127, 439127, 440127, 441127, 442127, 443127, 444127, 446127, 448127, 449127, 451127, 452127, 454127, 455127, 457127, 460127, 461127, 463127, 469127, 472127, 475127, 476127, 479127, 480127, 482127, 484127, 494127, 498127, 499127, 501127, 502127, 503127, 504127, 505127, 506127, 507127, 508127, 510127, 546127, 547127 & 548127..
• 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: 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.