Events

Rappel de Device Recall A M Systems ViroMax viral/bacterial filter

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 A M 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
    55294
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0308-2012
  • Date de mise en oeuvre de l'événement
    2010-03-31
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90493
  • 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
    Filter, bacterial, breathing-circuit - Product Code CAH
  • Cause
    Some viromax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.
  • Action
    A - M Systems sent a Urgent Notification of Product Recall/Correction dated March 31, 2010, to all affected customers. The letter identificed the product the problem and the action needed to be taken by the customer. Customers were instructed to cease use and/or distribution of the affected product and to immediately notify any of their sub-accounts with the same information. Customers are asked to provide A - M Systems with the amount distributed and amount remaining in inventory and to then destroy or discard any remaining product in their possession. Please call 360.683.8300, if you have any questions or concerns.

Device

Device Recall A M Systems ViroMax viral/bacterial filter
  • Modèle / numéro de série
    Lot numbers: 551278, 551311, 551355, 551425, 551432, 551452, 551635, 551658, 551699, 551704, 551727, 551732, 551746, 551800, 551879, 551905, 551954 and 552095.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA ( nationwide) including the states of AZ, CA, FL, KY, MA, MI, NC, OH, OR, and WI., and the countries Canada, Mexico, and Taiwan.
  • Description du dispositif
    ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients || For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.
  • Manufacturer
    A M Systems Inc

Manufacturer

A M Systems Inc
  • Adresse du fabricant
    A M Systems Inc, 131 Business Park Loop, P.O. Box 850, Sequim WA 98382-0850
  • Source
    USFDA