Events

Rappel de Device Recall Integra NeuroSensor

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 Integra Neuro Sciences.

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
    46788
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1191-2008
  • Date de mise en oeuvre de l'événement
    2008-01-28
  • Date de publication de l'événement
    2008-08-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-04-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68272
  • 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
    intracranial pressure probe - Product Code GWM
  • Cause
    Incorrect pressure reading: due to a manufacturing error, the icp reading could be inaccurate to the extent that they exceed label claims. specifically, the insertion error label claim of +/- 3mmhg could be exceeded by up to -3mmhg, that could result in a maximum insertion error of +/- 6mmhg.
  • Action
    Integra NeuroSciences sent a Recall Notification with a Recall Acknowledgement form to all customers with product currently in their possession through an Integra Field Sales Repesentative on January 28, 2008. The notification advises that the firm has determined that due to a manufacturing error, the ICP reading could be inaccurate to the extent that they exceed label claims. Specifically, the Insertion Error label claim of +/- 3mmHg could be exceeded by up to -3mmHg that could result in a maximum Insertion Error of +/- 6mmHg. Customers are asked to examine their inventory immediately to determine if they have any NeuroSensor Model NS-P's lot #100063 on hand and if so to not use the product. Customers are advised to contact their local Integra representative for further assistance. The letter advises that the lot/serial number is located on a white 1/2" x 1/2" label on the large beige optical connector, and can readily be seen through the bottom of the product tray packaging. The letter also advises that this recall pertains to NeuroSensor Model NS-P's, lot # 100063 -all serial numbers. A response form is included. In addition, the Field Sales Representatives have been instructed to physically remove all lot 100063 of NeuroSensor Probes from inventory and provide replacement product.

Device

Device Recall Integra NeuroSensor
  • Modèle / numéro de série
    Lot 100063, all serial numbers
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Distribution: CA, GA, NM, TX, NE, WA, and NY.
  • Description du dispositif
    INTEGRA NeuroSensor Probe, REF NS-P, component of Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Integra NeuroSciences
  • Manufacturer
    Integra Neuro Sciences

Manufacturer

Integra Neuro Sciences
  • Adresse du fabricant
    Integra Neuro Sciences, 5955 Pacific Center Blvd, San Diego CA 92121-4309
  • Source
    USFDA