Events

Rappel de Device Recall MEDRAD Intego PET Infusion System

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 Bayer Healthcare.

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
    75736
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0927-2017
  • Date de mise en oeuvre de l'événement
    2016-11-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-10-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151118
  • 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
    Pump, infusion - Product Code FRN
  • Cause
    Bayer has determined that all current source administration sets (sas) used with the medrad intego pet infusion system may produce particulates in radiopharmaceutical (rp) vials when the needle is inserted.
  • Action
    Bayer mailed an Urgent Medical Device Field Safety Notice dated November 3. 2017 to affected customers to inform them of the issue. Customers were asked to immediately quarantine unused product and resume use once the qualified in-line filter is received or to request a RGA (Return Goods Authorization) number to return the product. Customers were asked to complete the response form indicating if their institution does or does not have affected product and return the form via fax to 1-412-406-0941. Customers with questions were instructed to contact the Customer Care team at 1-800-633-7231, opt 2. For questions regarding this recall call 412-767-2400. On December 5, 2016, the recalling firm sent a new letter indicating the inline filter has been successfully tested and that they have qualified a compatible in-line filter to be used with the Patient Administrative Set (PAS) that will allow you to resume use of your Intego system.

Device

Device Recall MEDRAD Intego PET Infusion System
  • Modèle / numéro de série
    Device Listing # D053816
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    MEDRAD Intego PET Infusion System - Pump || Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. It is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 radiation exposure during nuclear medicine diagnostic procedures.
  • Manufacturer
    Bayer Healthcare

Manufacturer

Bayer Healthcare
  • Adresse du fabricant
    Bayer Healthcare, 1 Bayer Dr, Indianola PA 15051-9702
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    USFDA