Events

Rappel de Device Recall AMS600B, AMS700B A Magellan Dispenser Tip

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-0345-2011
  • 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=94776
  • 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
    Syringe, irrigating (non dental) - Product Code KYZ
  • 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 AMS600B, AMS700B A Magellan Dispenser Tip
  • Modèle / numéro de série
    Model / Lot #:  AMS600-B / 113501, AMS700-B / 113511, SA-0105 / 114156, SA-3675 / 114453 / 113532, SA-3678 / 114275.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • 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
    AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 || Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number || AMS600-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. || Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number || AMS700-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. || Fibrijet, Applicator Tip Dual Cannula Malleable 26 ga x3" (7.6cm), Catalog Number SA-0105, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. || Fibrijet, Mixing Applicator Tip Low Viscosity with Spray Tip, Catalog Number SA-3675, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. || Fibrijet, Blending Connector with Mixer, Catalog Number SA-3678, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA
  • 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