Events

Rappel de Device Recall ACIST Automated Manifold Kit

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
    52199
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1872-2009
  • Date de mise en oeuvre de l'événement
    2009-05-11
  • Date de publication de l'événement
    2009-08-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82491
  • 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
    Angiographic injector and syringe - Product Code DXT
  • Cause
    Acist medical systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of bt2000 kits during a procedure which can result in unsatisfactory performance of the acist bt2000 automated manifold kit.
  • Action
    Consignees were sent on 5/11/09 a ACIST Medical Systems "Urgent: Medical Device Recall" letter dated May 11, 2009. The letter described the problem and the product. It advised consignees to discontinue the use or further distribution of the recall product and to return the inventory and the enclosed "Medical Device Recall Form". Please use the enclosed form with firms address: 7905 Fuller Rd, Eden Prairie, MD 55344. Additional questions please contact the firm at 1-877-272-2269, option 1.

Device

Device Recall ACIST Automated Manifold Kit
  • Modèle / numéro de série
    Lot numbers: 2968J 3088N 3168H 3178H 2968K 3088P 3168J 3308U 2968L 3088T 3168K 3468W
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, ID, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE,NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT VA, WA, and WI.The countries of CANADA and HONG KONG
  • Description du dispositif
    ACIST Automated Manifold Kit , REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico, Manufacturer; ACIST LMedical Systems Inc, 7605 Fuller Road, Eden Prairie, MN .55344. || The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is for single use.
  • Manufacturer
    Acist Medical Systems

Manufacturer

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