Events

Rappel de Device Recall MicroFuel Cell Oxygen Sensor, Class RI5

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 Teledyne Instruments - Analytical Instruments.

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
    58322
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3001-2011
  • Date de mise en oeuvre de l'événement
    2010-11-29
  • Date de publication de l'événement
    2011-08-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98984
  • 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
  • Cause
    The recall was initiated because during a test on a batch of sensors on the company shipping dock, teledyne instruments discovered electrolyte loss from the sealing cylinder on a few sensors. this test was done pursuant to a complaint from one customer of label discoloration caused because of the electrolyte loss. the risk of a leak form the oxygen sensor while in use is the disruption of therape.
  • Action
    Teledyne Instruments sent emails and "Urgent--Device Field Corrections/Removal" letters in December 2010 to all affected customers. Th letter includes description of device and problem. Customers are advised to check them before use for any signs of electrolyte loss and if discoloration is noted to discontinue its use. and provides recommendation. Teledyne-desplaines to generate a product field corrections/removal log that lists names/addresses of the consignees, quantity of sensors shipped, sensor serial numbers and the date of shipment. For additional information or questions contact Teledyne Instruments at (626) 934-1504.

Device

Device Recall MicroFuel Cell Oxygen Sensor, Class RI5
  • Modèle / numéro de série
    Sensor Part Number: C41131-R15. Serial Numbers: 593875 to 593894 (20), 599156 to 599254(99), 611100 to 611599 (500), 617125 to 617674(550), 642023 to 642472 (450), 642474 to 642475 (2), 642485 to 643022 (538), 666158 to 666657 (500), 668499 to 668647 (149), and 668652 to 668656 (5).
  • Classification du dispositif
    Anesthesiology Devices
  • Distribution
    Worldwide Distribution: Nationwide (US) distribution including the states of CA, TN and WI; and the countries of , Canada, Brazil, Chile, Saudi Arabia, and the U.K.
  • Description du dispositif
    Micro-Fuel Cell Oxygen Sensor, Class RI5 || Sensor Part Number: C41131-R15 || Teledyne Instruments - Analytical Instruments || Disposable oxygen sensors with limited useful life. These sensors are accessories to other oxygen diagnostic devices, and are not in themselves suitable for therapeutic use.
  • Manufacturer
    Teledyne Instruments - Analytical Instruments

Manufacturer

Teledyne Instruments - Analytical Instruments
  • Adresse du fabricant
    Teledyne Instruments - Analytical Instruments, 16830 Chestnut St, City Of Industry CA 91748-1017
  • Source
    USFDA