Events

Rappel de Device Recall FASTRAC "Pull" Gastric Access Port

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 C.R. Bard Access Systems, Inc.

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
    50678
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2185-2009
  • Date de mise en oeuvre de l'événement
    2008-12-04
  • Date de publication de l'événement
    2009-09-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84395
  • 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
    Polypectomy snare - Product Code KNT
  • Cause
    Snare can detach in patient. the polypectomy snares and the entake peg system (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
  • Action
    Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.

Device

Device Recall FASTRAC "Pull" Gastric Access Port
  • Modèle / numéro de série
    Lots: 43ARA073, 43DQA028, 43DQA029, 43DQA030, 43FQA053, 43FOA054, 43FQA055, 43FQA056, 43FQA057, 43FQA058, 43FQA059, 43GQA058, 43GQA059, 43GQA060, 43GQA061, 43GQA062, 43GQA063, 43GQA064, 43GQA065, 43HQA053, 43HQA187, 43IQA054, 43JQA055, 43JQA056, 43KQA070, 43KQA071, 43KQA072, 43LQA073, 43LQA074, HURA1470, HURA1471, HURA1472, HURA1473, HURB2558, HURB2559, HURD1498, HURD1644, HURD1798, HURD1799, HURD1800, HURD1801, HURE2820, HURE2821, HURE2822, HURE3300, HURE3301, HURE3302, HURE3303, HURF0404, HURF0405, HURF0406, HURG0210, HURG1382, HURG1383, HURG1384, HURG1385, HURH0869, HURH0870, HURH0871, HURH0872, HURH0873, HURI0518, HURI1003, HURI1203, HURI1204, HURI1205, HURJ0306, HURJ0308, HURJ0309, HURJ0312, HURJ1440, HURK1457, HURK1458, HURK1459, HURK1460, HUSA0275, HUSA0276, HUSB0097, HUSC0158, HUSC0159, HUSC1201, HUSC1763, HUSD0095, HUSD0096, HUSD0097, HUSD0098, HUSD1936, HUSD1937, HUSD1938, HUSD1939, HUSE1505, HUSE1506, HUSE1508, HUSF0001, HUSF1748.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Belgium, Canada, Australia, and Japan.
  • Description du dispositif
    Bard Access Systems, Inc., FASTRAC* "Pull" Gastric Access Port Safety System, REF 006033, 20F, Sterile.
  • Manufacturer
    C.R. Bard Access Systems, Inc

Manufacturer

C.R. Bard Access Systems, Inc
  • Adresse du fabricant
    C.R. Bard Access Systems, Inc, 5425 Amelia Earhart Dr, Salt Lake City UT 84116-3713
  • Source
    USFDA