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.
FDA Recall Z-3001-2011 · Posted 2011-08-11
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Recalling FirmTeledyne Instruments - Analytical Instruments
Recall StatusTerminated
Date Initiated2010-11-29
Date Terminated2011-08-22
Product Quantity2813
Reason for Recall
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
Firm 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.
Root Cause
Process design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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