Events

Rappel de Device Recall Shiley TracheoSoft

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
    29653
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1312-04
  • Date de mise en oeuvre de l'événement
    2004-07-08
  • Date de publication de l'événement
    2004-08-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34291
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    unknown device name - Product Code ---
  • Cause
    Device component can become disconnected or dislodged, leading to ineffective ventilation, which could result in serious injury or death.
  • Action
    On 7/8/04, the firm initiated the recall. ***[After CDRH recommendations for class I recall situation, the firm issued PR via AP on 8/6/04.]*** .

Device

Device Recall Shiley TracheoSoft
  • Modèle / numéro de série
    All units of these models.
  • Classification du dispositif
    Anesthesiology Devices
  • Distribution
    The tracheostomy tubes were distributed to 4,179 direct US and US Territory customers. The firm has also distributed products to Canada, the UK, Latin America and Japan. The firm's branches in those countries are handling the recall activities in those countries. The firm manufactured 95,923 units and distributed 71.021 throughout the US and US territories. 4,481 are on hold at the Nellcor distribution facility, and approximately 3000 units are currently in distribution.
  • Description du dispositif
    Shiley TracheoSoft¿ XLT Extended Length Tracheostomy tube; || Model Numbers: || 72110-050, size 5, Proximal Extension, Uncuffed; || 72110-060, size 6, Proximal Extension, Uncuffed; || 72110-070, size 7, Proximal Extension, Uncuffed; || 72110-080, size 8, Proximal Extension, Uncuffed; || 72120-050, size 5, Promixal Extension, Cuffed; || 72120-060, size 6, Promixal Extension, Cuffed; || 72120-070, size 7, Promixal Extension, Cuffed; || 72120-080, size 8, Promixal Extension, Cuffed; || 73110-050, size 5, Distal Extension, Uncuffed; || 73110-060, size 6, Distal Extension, Uncuffed; || 72110-070, size 7, Distal Extension, Uncuffed; || 73110-080, size 8, Distal Extension, Uncuffed; || 73120-050, size 5, Distal Extension, Cuffed; || 73120-060, size 6, Distal Extension, Cuffed; || 73120-070, size 7, Distal Extension, Cuffed; || 73120-080, size 8, Distal Extension, Cuffed; || 77100-050, size 5 XLT Disposal Inner Cannula; || 77100-060, size 6 XLT Disposal Inner Cannula; || 77100-070, size 7 XLT Disposal Inner Cannula; || 77100-080, size 8 XLT Disposal Inner Cannula || Manufactured by Mallinckrodt Medical, County Westmeath Cornamaddy, Athlone, Ireland; || Customer Service: Mallinckrodt, Inc. St Louis, MO 63134
  • Manufacturer
    Nellcor Puritan Bennett

Manufacturer

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