Events

Rappel de Device Recall Pulsiocath PiCCO ProAQT Monitoring 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 Pulsion 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
    69782
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1121-2015
  • Date de mise en oeuvre de l'événement
    2014-11-04
  • Date de publication de l'événement
    2015-02-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131534
  • 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
    Probe, thermodilution - Product Code KRB
  • Cause
    Internal testing and investigation of the packaging revealed cracks and holes in primary packaging.
  • Action
    Pulsion sent an Urgent Medical Device Recall notification letter on 11/04/14 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers where instructed to: " Piease examine your inventory immediately to determine if you have any of the products listed. " lf so, please remove the affected products; quarantine them in a secure location. " Piease complete and return the enclosed Field Recall Response Form, acknowleding your receipt and understanding of this communication " Send all affected products back to PULSION Medical Systems. " Upon return of the affected product you will receive a credit note. For questions contact your PULSION Medical lnc Recall Coordinator.

Device

Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit
  • Modèle / numéro de série
    Model Number PV8810US; Lot # 14AK20 and 14EK20
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
  • Description du dispositif
    Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. || Product Usage: || Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
  • Manufacturer
    Pulsion Medical Inc

Manufacturer

Pulsion Medical Inc
  • Adresse du fabricant
    Pulsion Medical Inc, 3781 Attucks Dr, Powell OH 43065-6080
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA