Events

Rappel de Device Recall 3M AttestTM Autoreader

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 3M Company - Health Care Business.

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
    68415
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2002-2014
  • Date de mise en oeuvre de l'événement
    2014-06-09
  • Date de publication de l'événement
    2014-07-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127541
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • Cause
    Labeling on units shipped prior to may 16th, 2014 did not contain the statement "this product contains dry natural rubber" as required by the united states food and drug administration (fda) for medical devices. the non-slip pads at the bottom of the unit contain dry natural rubber. one incident of an allergic reaction in a sensitized individual has been reported.
  • Action
    Consignees were sent on 6/9/2014 a 3M "Urgent Medical Devices Correction" letter dated May 21, 2014. The letter described the problem and the product involved in the recall. The letter described what action is 3M taking and what action was required of the consignees. Consignees were sent an adhesive label and a response card. They requested consignees to adhere the label to a portion of the plastic covering each unit in a location where it is visible to the end-user. After that, they are requested to fill out and return the response card.

Device

Device Recall 3M AttestTM Autoreader
  • Modèle / numéro de série
    All serial numbers.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.
  • Description du dispositif
    3M Attest Auto-reader. Model numbers 390, 390G,and 490. || These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • Adresse du fabricant
    3M Company - Health Care Business, 3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144
  • Société-mère du fabricant (2017)
    3m Company
  • Source
    USFDA