BOULDER, Colo., Jan 19, 2012 (BUSINESS WIRE) -- On November 8, 2011, Covidien initiated a voluntary recall of certain lots of its BIS(TM) Bilateral Sensors, due to a modification which inadvertently reversed the reference and left eye electrode. This modification could potentially cause a change in the performance of BIS monitoring systems when these sensors are used, resulting in the inaccurate calculation and presentation of processed EEG information for Bispectral Index(TM) (BIS), Density Spectral Array (DSA), and Asymmetry (ASYM) values.
To date, there have been no reports of patient injury related to the recalled products.
The voluntary recall only affects lot numbers manufactured during a specific period of time. Only BIS Bilateral Sensors from the 58 lot numbers listed below are affected by this action.
Customers were first notified about this issue by letter dated November 8, 2011. The Company has taken appropriate steps to address the issue, and adequate supplies of unaffected replacement product are available.
Customers should review product in inventory and current use to identify product from the affected lot codes and return affected lots to Covidien. To return the affected product for replacement product, contact Technical Services at 1-800-635-5267, option 3, then option 1, and reference the Return Goods Authorization (RGA) Number in the recall letter.
Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or by phone.
-- Online: www.fda.gov/medwatch/report.htm
-- Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm . Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
-- Fax: 1-800-332-0178
-- Phone: 1-800-332-1088
Rhonda Luniak, 303-406-8743
Vice President, Communications
Respiratory & Monitoring Systems
Bruce Farmer, 508-452-4372
Coleman Lannum, CFA, 508-452-4343
Todd Carpenter, 508-452-4363