Recall of Device Recall MicroFuel Cell Oxygen Sensor, Class RI5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Teledyne Instruments - Analytical Instruments.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58322
  • Event Risk Class
    Class 2
  • Event Number
    Z-3001-2011
  • Event Initiated Date
    2010-11-29
  • Event Date Posted
    2011-08-11
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2011-08-22
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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

  • Model / Serial
    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).
  • Product Classification
  • 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.
  • Product Description
    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

Manufacturer

  • Manufacturer Address
    Teledyne Instruments - Analytical Instruments, 16830 Chestnut St, City Of Industry CA 91748-1017
  • Source
    USFDA