Events

Rappel de Device Recall VT010150 Otological Ventilation Tubes

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 Micromedics, 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
    56874
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0348-2011
  • Date de mise en oeuvre de l'événement
    2010-03-15
  • Date de publication de l'événement
    2010-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94875
  • 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
    Tube, tympanostomy - Product Code ETD
  • Cause
    Micromedics, inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches, potentially resulting in a non-sterile product which may cause transmission of disease or infection.
  • Action
    Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement. Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.

Device

Device Recall VT010150 Otological Ventilation Tubes
  • Modèle / numéro de série
    Model / Lot #: VT-0101-50 / 114449, VT-0204-01 / 113210, VT-0406-01 / 113228, VT-0503-01 / 113243/ 113218 , VT-0503-50 / 113236 , VT-0507-01 / 114538, VT0508-50 / 113788, VT-1002-50 / 113248, VT-1035-01 / 114452, VT1204-01 / 113222, VT-1421-01 / 113431.  Model / Lot #: ET-ABGDT-45 / 114651 ET-GTST-45-12 / 114664 ET-SPDT-40T / 114522 ET-TBDT-45 / 114390
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI. FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.
  • Description du dispositif
    VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab, 1.14 mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT-0204-01 || Otological Ventilation Tubes, Catalog Number VT-0204-01, Shepard, 1.0 mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT-0406-01 || Otological Ventilation Tubes, Catalog Number VT-0406-01, T-Tube, 5mm x 4mm x 1.14mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT-0503-01 || Otological Ventilation Tubes, Catalog Number VT-0503-01, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT-0503-50 || Otological Ventilation Tubes, Catalog Number VT-0503-50, Armstrong Grommet, 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT-0507-01 || Otological Ventilation Tubes, Catalog Number VT-0507-01, Armstrong Grommet w/wire, 1.14mm Lumen, FL, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT0508-50 || Otological Ventilation Tubes, Catalog Number VT-0508-50, Modified Armstrong Grommet 1.14mm Lumen, Fluoroplastic, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT-1002-50 || Otological Ventilation Tubes, Catalog Number VT-1002-50, Collar Button, 1.27mm Lumen, Silicone, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT-1035-01 || Otological Ventilation Tubes, Catalog Number VT-1035-01, Collar Button, 1.5mm Lumen, Titanium, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT1204-01 || Otological Ventilation Tubes, Catalog Number VT-1204-01, Reuter Bobbin 1.14mm , Lumen, FL Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || VT-1421-01 || Otological Ventilation Tubes, Catalog Number VT-1421-01, Angled Tab Bobbin 1.27mm Lumen, TI, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc., St Paul, MN 55121-1385 USA. || ET-ABGDT-45 || Distributed By API Anthony products, Inc., ET-ABGDT-45 Armstrong Grommet, 1.14mm Lumen, FP Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. || ET-GTST-45-12, || Distributed By API Anthony products, Inc., ET-GTST-45-12, T-tube 12 x 10, 1.14mm Lumen, SI , Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. || ET-SPDT-40T, || Distributed By API Anthony products, Inc., ET-SPDT-40T Shea Parasol w/Tab, 1.0mm Lumen, SI, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes. || ET-TBDT-45 || Distributed By API Anthony products, Inc., ET-TBDT-45 Reuter Bobbin w/c Holes 1.14mm Lumen, FP, Sterilized by Ethylene Oxide, Rx Only, Micromedics, St Paul, MN 55121-1385 USA, Otological Ventilation Tubes.
  • Manufacturer
    Micromedics, Inc.

Manufacturer

Micromedics, Inc.
  • Adresse du fabricant
    Micromedics, Inc., 1270 Eagan Industrial Rd Ste 120, Eagan MN 55121-1385
  • Société-mère du fabricant (2017)
    Nordson Corporation
  • Source
    USFDA