Events

Recall of Device Recall Aquapak 340 SW, 340, mL w/040 Adaptor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teleflex Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68493
  • Event Risk Class
    Class 2
  • Event Number
    Z-2006-2014
  • Event Initiated Date
    2014-06-05
  • Event Date Posted
    2014-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128061
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • Reason
    The seals of the adaptor packaging may be creased which may potentially affect packaging integrity.
  • Action
    Consignees were notified by letter on 06/06/2014.

Device

Device Recall Aquapak 340 SW, 340, mL w/040 Adaptor
  • Model / Serial
    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..
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand and Zambia.
  • Product Description
    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Manufacturer Address
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA