Events

Rappel de Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor

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 Nellcor Puritan Bennett.

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
    29892
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1414-04
  • Date de mise en oeuvre de l'événement
    2004-08-24
  • Date de publication de l'événement
    2004-09-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-12-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34735
  • 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
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase - Product Code CCK
  • Cause
    The product is contaminated with burkholderia cepacia (formally known as pseudomonas cepacia), based on the texas health department analysis and also firm's analysis.
  • Action
    On 8/24/04 the firm issued letters via Fax to all its direct consignees, informing them of the affected product and providing instructions on the recall. The firm followed up with phone calls to all consignees completed by 8/25/04. The firm also issued a press release via Associated Press on 8/27/04.

Device

Device Recall Nellcor CapnoProbe SLS1 sublingual Sensor
  • Modèle / numéro de série
    All lots of the CapnoProbe are under recall. Each unit has a code number printed on the packaging.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The firm has distributed the sensors to 1 researcher in Europe, and 68 to direct customers (medical facilities) and 112 Field Sales Reps. Currently, there are no finished goods at the manufacturing site. 655 cases of product were disposed of at the distribution facility due to product expiration. The firm estimates 442 cases (3,536 units) to be in distribution channels.
  • Description du dispositif
    The probes involved have been part of the Nellcor¿ CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is in a sealed foil envelope. Each disposable probe is used only one time.
  • Manufacturer
    Nellcor Puritan Bennett

Manufacturer

Nellcor Puritan Bennett
  • Adresse du fabricant
    Nellcor Puritan Bennett, 4280 Hacienda Dr, Pleasanton CA 94588-2719
  • Source
    USFDA