Events

Rappel de Device Recall Secure

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 The Metrix Company.

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
    74043
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2257-2016
  • Date de mise en oeuvre de l'événement
    2016-06-23
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146045
  • 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
    System/device, pharmacy compounding - Product Code NEP
  • Cause
    An issue was identified after a redesign of the auto compounding device. the compounder cannot meet the designed accuracy specification when dispensing into bags. after reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.
  • Action
    On 6/23/2016, the recalling firm sent written recall notices to their distributors and end users notifying them of the recall. Customers and consignees were instructed to not use the devices, locate and quarantine all affected devices, and to complete the response form.

Device

Device Recall Secure
  • Modèle / numéro de série
    000001, 003002, 003003, 003004, 003005, 003006, 003007, 003008, 003009, 003010, 003011, 003012, 003013, 003014, 003015, 003016, 003017, 003018, 003019, 003020, 003023, 003024, 003025, 003026, 003027, 003028, 003029, 003030, 003031, 003036, 003037, 003038, 003039, 003040, 003041, 003042, 003043, 003044, 003045, 003046, 003047, 003048, 003049, 003050, 003051, 003052, 003053, 003054, 003055, 003056, 003057
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product distributed to medical facilities in the following US states: AL, AZ, CA, CO, CT, FL, IA, IL, KS, LA, MA, MD, MN, NC, OH, PA, PR, TN, TX, UT, and WA. Product was also distributed internationally to the following countries: Australia, Canada, Dominican Republic, Malaysia, Turkey, and United Kingdom
  • Description du dispositif
    AUTOCOMP6 XPS High Speed Compounder REF 58810
  • Manufacturer
    The Metrix Company

Manufacturer

The Metrix Company
  • Adresse du fabricant
    The Metrix Company, 4400 Chavenelle Rd, Dubuque IA 52002-2655
  • Société-mère du fabricant (2017)
    The Metrix Company
  • Source
    USFDA