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Press release from Business Wire

Covidien Provides Update on Voluntary Recall of BIS™ Bilateral Sensors

Thursday, January 19, 2012

Covidien Provides Update on Voluntary Recall of BIS™ Bilateral Sensors07:00 EST Thursday, January 19, 2012 BOULDER, Colo. (Business Wire) -- On November 8, 2011, Covidien initiated a voluntary recall of certain lots of its BIS™ 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™ (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.                                           0528111A       0624111A       0727111A       0811111A       0824111A       0926111A 0603111A       0625111A       0727111B       0812111A       0824111B       0927111A 0604111A       0627111A       0728111A       0813111A       0825111A       0930111A 0606111A       0701111A       0728111B       0814111A       0825111B       1001111A 0607111A       0707111A       0729111A       0820111A       0826111A       1003111A 0608111A       0712111A       0729111B       0821111A       0826111B       1004111A 0609111A       0713111A       0801111A       0822111A       0921111A       1005111A 0615111A       0725111A       0808111A       0822111B       0923111A       1006111A 0620111A       0726111A       0809111A       0823111A       0923111B         0621111A       0726111B       0810111A       0823111B       0924111A                                       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 CovidienRhonda Luniak, 303-406-8743Vice President, CommunicationsRespiratory & Monitoring Systemsrhonda.luniak@covidien.comorBruce Farmer, 508-452-4372Vice PresidentPublic Relationsbruce.farmer@covidien.comorColeman Lannum, CFA, 508-452-4343Vice PresidentInvestor Relationscole.lannum@covidien.comorTodd Carpenter, 508-452-4363DirectorInvestor Relationstodd.carpenter@covidien.com