Covidien Updates Voluntary Recall of BIS™ Bilateral Sensors.

Abstract

Covidien has reinforced implementation of its voluntary recall of BIS bilateral Sensors, undertaken last November, with a reminder in the form of an update, that use of affected iterations of the product could result in what the company refers to as inaccurate calucation and presentation of key data.

Background

Dating back to 1994, measurement of Bispectral index (BIS) has become an important means of assessing depth of anaesthesia. The so-called “consciousness monitoring technology”, originally developed by Aspect Medical Systems, was acquired by Covidien in 2009 and in its “bilateral” sensor form provides the capability to detect hemispheric differences in the brain, which may prove useful for advanced monitoring applications.

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 inaccurate calculation and presentation of processed EEG information for Bispectral Index™ (BIS), Density Spectral Array (DSA), and Asymmetry (ASYM) values.

Importantly, to date, there have been no reports of patient injury related to the recalled products.

Affected 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.

What to do 

Customers should review product in inventory and current use to identify product from the affected lot codes and return affected lots to Covidien. Additionally, any adverse events should be reported to Covidien.

Source: Covidien