Events

Rappel de Device Recall Diana

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 ICU Medical, 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
    73528
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1365-2016
  • Date de mise en oeuvre de l'événement
    2016-03-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144404
  • 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
    Icu medical inc. has received a report of compounded volumes not meeting the accuracy specification by the diana compounding system when mixing volumes under 5ml.
  • Action
    ICU Medical, Inc. sent customer notification letter dated March 8, 2016, to customers to inform them that ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml. The letter informs the customers that ICU Medical will provide an updated Operator's Manual to provide clarity on the difference between Operating Range and Accuracy Range as soon as they are available. Customers are informed that the updated specifications are provided with the customer communication and to be used until the Operators Manual is provided. Customers are instructed to return the completed Medical Device Safety Communication Response form to ICU Medical via Fax (801) 264-1755 or by email at recall@icumed.com. Customers with any questions or require assistance relating to the customer notification letter are instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: (866)8299025 and select option 8, or email the following address: productreturns@icumed.com.

Device

Device Recall Diana
  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution to Nationwide in AL, AZ, CA, CO, CT, DC, GA, IL, MD, MI, MN, MO, NC, NH, NJ, NY, OH, OK, PA, TN, TX, VA.. Worldwide: AU, BE, BR, CA, CH, DE, DZ, EE, EG, ES, FI, FR, HK, HR, IL, IT, JO, KR, MX, NL, PL, SA, SE, SI, TR.
  • Description du dispositif
    Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R || The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
  • Manufacturer
    ICU Medical, Inc.

Manufacturer

ICU Medical, Inc.
  • Adresse du fabricant
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Société-mère du fabricant (2017)
    ICU Medical, Inc.
  • Source
    USFDA