Events

Rappel de Device Recall Merit One Step Centesis Drainage Catheter

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 Merit Medical 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
    57418
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0866-2011
  • Date de mise en oeuvre de l'événement
    2010-11-17
  • Date de publication de l'événement
    2011-01-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96167
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    Catheter, irrigation - Product Code gbx
  • Cause
    The catheter's valved hub may fail resulting in an inability to drain fluid.
  • Action
    Merit Medical Systems, Inc. sent a Product Safety Notice letter dated November 18, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide a copy of the Safety Notice form to their applicable customers. Advise them to immediately stop using the affected product and to discard it. Customers were asked to complete and sign the Safety Notice forms and fax them to 1-801-208-3378 and send the original Safety Notice Form with both signatures via Federal Express 2nd day air to: Customer Service Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095-2416 entirety and faxed them For questions regarding this recall call 801-316-4929 or Customer Service at 801-208-4365.

Device

Device Recall Merit One Step Centesis Drainage Catheter
  • Modèle / numéro de série
    LOT NO.: F762656, F762657, F775508, F775516, F775524, F775533, F775552. . . . H101842, H101902, H108630, H110628, H110629, H110630, H110631, H113645, H113655, H115407, H115409, H118206 ,H118207, H118208, H118209, H118210, H118211, H121450, H121780, H124502, H124506, H124507, H124508, H124509, H124510, H124511, H134990, H134991, H134992, H134993, H134994, H137477, H139171, H141155, H141162, H144090, H144098, H152489, H161044, H168461, H176238, . . . . . T119693, T121646, T122832,T124548, T130679, T132868, T132953, T133542, T134201, T135053, T137437, T139844, T140413, T140414, T141401, T141403, T141404, T142352, T143776, T146337, T146360, T149794, T150330, T150862, T151354, T153082, T153417, T153437, T153683, T153684, T153987, T154640, T157268, T160213, T162756, T167168, T167454, T167544, T168498, T171102, T171125, T171265, T173628, T173860, T174223, T176638, T176932, T177808, T178914, T179018, T179791, T181437
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, AND WV and the countries of Canada, Finland, Germany, Netherlands, Singapore, Sweden, Switzerland, and the UK
  • Description du dispositif
    Merit One Step Centesis Drainage Catheter || Intended for the percutaneous drainage of fluids
  • Manufacturer
    Merit Medical Systems, Inc.

Manufacturer

Merit Medical Systems, Inc.
  • Adresse du fabricant
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Société-mère du fabricant (2017)
    Merit Medical Systems Inc
  • Source
    USFDA