Z-3001-2011

Micro-Fuel Cell Oxygen Sensor, Class RI5 Sensor Part Number: C41131-R15 Teledyne Instruments - Analytical...

Name: Z-3001-2011 Micro-Fuel Cell Oxygen Sensor, Class RI5 Sensor Part Number: C41131-R15 Teledyne Instruments - Analytical...
Creator: Teledyne Instruments - Analytical Instruments
Published: 2010-11-29
License: https://open.fda.gov/license/

Teledyne Analytical Instruments / initiated 2010-11-29 / Terminated / root cause: manufacturing process

FDA source

Teledyne Instruments - Analytical Instruments began a recall of Micro-Fuel Cell Oxygen Sensor, Class RI5 Sensor Part Number: C41131-R15 Teledyne Instruments - Analytical Instruments Disposable oxygen sensors with limited... on 2010-11-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3001-2011
Status: Terminated
Initiated: 2010-11-29
Posted: 2011-08-11
Terminated: 2011-08-22
Recalling firm: Teledyne Analytical Instruments
Product: 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.
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
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 2813
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 codes and lots: 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).

K001095Class IIOxygen Sensors, Models Cir, C2r, R13, R15, Ri7med, R22med, R23, R24med, R29med, T1, T2,t4, T7 & Ufo130Teledyne Analytical Instruments / cleared 2000-06-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)