Events

Rappel de Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 2

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 Teleflex Medical.

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
    37665
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0859-2007
  • Date de mise en oeuvre de l'événement
    2007-03-23
  • Date de publication de l'événement
    2007-06-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-11-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51257
  • 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
    CPAP - Product Code BZD
  • Cause
    The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.
  • Action
    Teleflex Medical sent Urgent Medical Device Recall letters dated 3/23/07 via UPS 2nd Day Air to the direct accounts, informing them that the luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading. The accounts were requested to cease use of the affected units, remove them from use/stock, quarantine and destroy them. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units destroyed and if they are requesting replacement product. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Device

Device Recall Hudson RCI Infant Nasal CPAP Cannula, Size 2
  • Modèle / numéro de série
    catalog no. 1692, lot number 35069/23405;  catalog no. 1686, lot numbers 32069/21606, 32069/21706, 33069/22306
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Puerto Rico, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, El Salvador, Germany, Guatemala, Hong Kong, India, Israel, Kuwait, Malaysia, Mexico, New Zealand, Paraguay, Peru, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, and Venezuela
  • Description du dispositif
    Infant Nasal CPAP Cannula, Size 2; an Rx infant nasal prong continuous positive airway pressure (CPAP) cannula one inspiratory and one expiratory elbow connector; 10 units per case; Teleflex Medical, Research Triangle Park, NC 27709 U.S.A., Made in Mexico; The cannulas are sold as components in the following configurations: || a) catalog No. 1692: Infant CPAP Set intended for use with mechanical ventilators, which includes one cannula with one inspiratory and one expiratory elbow connector, two 10mm to 7.5mm adapters, one knit cap and two 6 inch sections of Velcro securing tape; || b) catalog No. 1686: Infant CPAP System intended for use with a water seal or spring loaded valve, and includes one cannula with one inspiratory and one expiratory elbow conenctor, two 4 ft. lengths of 10mm I.D. corrugated tubing, one 4 ft. pressure monitoring line, one 22mm to 10mm humidifier adapter, one knit cap and two 6 inch sections of Velcro securing tape;
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA