Events

Rappel de Hudson RCI

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
    61538
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1427-2012
  • Date de mise en oeuvre de l'événement
    2012-04-03
  • Date de publication de l'événement
    2012-04-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-05-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108383
  • 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
    Endoscope and/or accessories - Product Code KOG
  • Cause
    Teleflex medical received complaints that the bite block can become separated from the handle. if separation occurs, medical intervention may be required to remove the bite block from the patient's trachea or esophagus/gi tract.
  • Action
    Consignees received "Urgent Medical Device Recall Notification" letters on or about 04/03/2011. The letters described the issue and provided recommended actions regarding remaining product and returns. Questions were directed to Customer Service at (866) 804-9881 (US).

Device

Hudson RCI
  • Modèle / numéro de série
    Catalog number: 1140; Lot numbers: 02A0800905, 02C1100483, 02F1000054, 02J0902663, 02A0801994, 02C1101954, 02F1000055, 02J1000939, 02A1000256, 02C1102754, 02F1100700, 02J1001824, 02A1000257, 02D0800059, 02F1101638, 02J1001825, 02A1001314, 02D0801329, 02G0801052, 02K0801935, 02A1001766, 02D0900557, 02G0802642, 02K0803847, 02A1100326, 02D0901732, 02G0900707, 02K0803848, 02A1101331, 02D1100098, 02G0901295, 02K0803849, 02A1102273, 02E0800110, 02G0902610, 02K0900029, 02B0900298, 02E0800342, 02G1000387, 02K0901174, 02B1000808, 02E0802363, 02G1000547, 02K1000019, 02B1000809, 02E0900148, 02G1100211, 02K1000520, 02B1001744, 02E0900638, 02H0800052, 02L1000392, 02B1100389, 02E1000111, 02H0800366, 02L1002223, 02B1101712, 02E1001758, 02H0801439, 02M0900100, 02C0800010, 02E1002588, 02H0801440, 02M0900855, 02C0802808, 02E1100223, 02H0900911, 02M0901463, 02C0901197, 02E1101181, 02J0800358, 02M0902072, 02C1001856, 02F0801932, 02J0801231, 02M1000288, 02C1001857, 02F0900762, 02J0900815 and 02M1000824 and Catalog number: 41140 (sold internationally) Lot numbers: 02A1102347, 02C1000226, 02C1003651, 02C1100970, 02D1001954, 02D1002705, 02D1101766, 02E1000107, 02E1100311, 02G0900700, 02J0802603, 02J1001026, 02K0901769, 02K1000616, 02K1001588, 02L0901972 and 02L1000486.
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution, including Nationwide (USA) and the countries of Canada, Singapore, China, Denmark, Netherlands, India, Australia, Japan and the United Kingdom.
  • Description du dispositif
    Hudson RCI, BiteGard Oral Bite Block, Single Patient Use, Rx Only, Teleflex Medical, Research Triangle Park, NC. The Teleflex Medical BiteGard Molar Bite Black is a disposable single patient use device that fits between the patients molars to prevent the patient from closing their mouth entirely and from obstructing the Laryngeal Mask Airway (LMA) tube, in the case where one is used.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA