Events

Rappel de Device Recall Aquapak 340 SW, 340, mL w/040 Adaptor

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Teleflex Medical.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68493
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2006-2014
  • Date de mise en oeuvre de l'événement
    2014-06-05
  • Date de publication de l'événement
    2014-07-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128061
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
  • Cause
    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
  • Modèle / numéro de série
    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..
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA