Events

Rappel de Device Recall ACIST Medical Systems Automated Manifold Kits

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 Acist Medical Systems.

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
    72913
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0744-2016
  • Date de mise en oeuvre de l'événement
    2015-12-21
  • Date de publication de l'événement
    2016-02-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142494
  • 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
    Injector and syringe, angiographic - Product Code DXT
  • Cause
    Reports related to ingress of air into the manifold.
  • Action
    Acist sent an Urgent Medical Device Recall letter dated December 21, 2015, via e-mail to all affected consignees. The letter was addressed to Distribution Partner or Cardiac Cath Lab / Material Manager in the USA. In Europe, the letter was addresses to Purchasing Department. The letter described the problem and the product involved in the recall. Advised consignees to return affected units and to complete and return the Medical Device Recall Form. Distributors were further advised to send the recall letter to their customers. For questions or concerns, contact in US, ACIST Customer Service 1-888-670-7701 or your ACIST Sales Representative. Europe Direct contact ACIST Europe Customer Service +44 (0) 845 548 12 80 or contact your ACIST Sales Representative, Europe Indirect contact ACIST Europe Customer Service +31 45 750 70 25 or contact your Distributor. Distributors contact: ACIST Europe BV, Office: +31 (0)45 750 7015, Mobile: +31 (0)6 233 648 46.

Device

Device Recall ACIST Medical Systems Automated Manifold Kits
  • Modèle / numéro de série
    Lot Number  08915J 09015T 09115H 09315D 09615N 09615U 09715X 09815F 10115D 10215G 10415D 10415W 10415Y 10515P 11015L 11115K 11215U 11315M 11715J 11815G 11915D 12415J 12615P 13115M 13415W 13815G 13915T 14015P 14115M 14615D 14615M 15415G 15715D 16115H 16315L 16515E 16615Z 16815J 16915N 17115F 17615U 17815F 18215J 18415D 18515N 18715U 18815K 18915P 19015N 19115H 19315D 19415P 19515X 19715G 19815M 19915D 20115M 20315E 20715D 20815M 20915X 21115W 21815J 21815U 22015D 23715D 23815D 23815P 24415P 24615U 25015D 25515D 26415N 26715F 26815J 26815K 27115L 27215U 27315Z 27415H 27515D 29115D 29915E 29915F 30015E 30015F 32115M 32715G 32715V 32815M
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including all states except DE, MT, RI, UT, & VT and Internationally to Belgium, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Reunion, United Kingdom, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Estonia, Greece, Hong Kong, Hungary, Islamic Republic of Iran, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lithuania, Mexico, New Caledonia, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Bosnia and Herzegovina, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and Venezuela.
  • Description du dispositif
    ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. || The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). || To be used for the controlled infusion of radiopaque contrast media for angiographic procedures
  • Manufacturer
    Acist Medical Systems

Manufacturer

Acist Medical Systems
  • Adresse du fabricant
    Acist Medical Systems, 7905 Fuller Rd, Eden Prairie MN 55344-2137
  • Société-mère du fabricant (2017)
    Bracco Spa
  • Source
    USFDA