Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MicroFuel Cell Oxygen Sensor, Class RI5

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MicroFuel Cell Oxygen Sensor, Class RI5 see related information
Date Initiated by Firm November 29, 2010
Date Posted August 11, 2011
Recall Status1 Terminated 3 on August 22, 2011
Recall Number Z-3001-2011
Recall Event ID 58322
510(K)Number K001095  
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.
Code Information 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). 
Recalling Firm/
Manufacturer		 Teledyne Instruments - Analytical Instruments
16830 Chestnut St
City Of Industry CA 91748-1017
For Additional Information Contact
626-934-1500
Manufacturer 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
FDA Determined
Cause 2		 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = and Original Applicant = TELEDYNE ANALYTICAL INSTRUMENTS
-
-