FDA Medical Device Recalls (openFDA)
Teledyne Instruments - Analytical Instruments: 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.
- Recall number
- Z-3001-2011
- Recalling firm
- Teledyne Instruments - 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.
- Status
- Terminated
- Initiated
- 2010-11-29
- Posted
- 2011-08-11
- Terminated
- 2011-08-22
- 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
- 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
- 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.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- ["K001095"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 2026424
- Firm city
- City Of Industry
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28