Events

Rappel de Device Recall BacT/ALERT Blood Collection Adapter

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 bioMerieux, 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
    61362
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1336-2012
  • Date de mise en oeuvre de l'événement
    2012-03-05
  • Date de publication de l'événement
    2012-03-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107916
  • 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
    Tubes, vacuum sample, with anticoagulant - Product Code GIM
  • Cause
    The bact/alert blood collection adapter cap is no longer compatible with becton dickinson (bk) vacutainer safety lok blood collection set. the incompatibility is the blood collection set needle backing out of the adapter cap that results in an exposed sheathed needle that may lead to an accidental needlestick.
  • Action
    bioMerieux sent an Urgent Product Correction Notice letter dated March 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Ensure the letter and guidance on how to maintain control of the luer connector by securing it between the thumb and forefinger are distributed to all appropriate personnel within their organization. 2. Fill out and return the Acknowledgement Form by Fax to confirm receipt of the recall notice. For additional assistance or questions customers were instructed to contact their local bioMerieux Customer Service Representative at (800) 682-2666, option 3, then option 3 again. Industry customers should call 800- 634-7656, option 3. For questions regarding this recall call 314-731-8537.

Device

Device Recall BacT/ALERT Blood Collection Adapter
  • Modèle / numéro de série
    Catalog Number: 279012, 210361 and 410796
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide), Australia, Brazil, Canada, Chile, Columbia, Costa Rica, France, China, Indonesia, Korea, Mexico, Peru, Singapore, Ecuador, Dominican Republic, Philippines, Guatemala, Curacao, Thailand, United Arab Emirates, Andorra, Austria, Burkina Faso, Congo, Switzerland, Cameroon, Germany, Algeria, Estonia, Spain, France, Great Britain, French Guiana, Croatia, Israel, India, Italy, Kazakhstan, Lithuania, Latvia, Macedonia, Malta, New Caledonia, Netherlands, French Polynesia, Poland, Portugal, Reunion, Russia, Sweden, Slovenia, Chad, Turkey, South Africa, Saudi Arabia, Congo, Cote DIvoire, Denmark, Djibouti, Finland, Greece, Guadeloupe, Libyan Arab Jamahiriya, Jordan, Morocco, Martinique, Norway, Senegal, Togo, Yemen, Bangladesh, Georgia, Ghana, Uganda, and Qatar.
  • Description du dispositif
    BacT/ALERT Blood Collection Adapter || The BacT/ALERT Adapter Cap is intended for use as an aid to facilitate filling of blood into the BacT/alert Blood Culture Bottle when using a butterfly blood collection set.
  • Manufacturer
    bioMerieux, Inc.

Manufacturer

bioMerieux, Inc.
  • Adresse du fabricant
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Société-mère du fabricant (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA