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.
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0528111A |
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0624111A |
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0727111A |
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0811111A |
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0824111A |
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0926111A |
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0603111A |
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0625111A |
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0727111B |
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0812111A |
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0824111B |
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0927111A |
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0604111A |
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0627111A |
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0728111A |
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0813111A |
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0825111A |
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0930111A |
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0606111A |
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0701111A |
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0728111B |
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0814111A |
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0825111B |
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1001111A |
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0607111A |
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0707111A |
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0729111A |
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0820111A |
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0826111A |
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1003111A |
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0608111A |
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0712111A |
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0729111B |
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0821111A |
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0826111B |
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1004111A |
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0609111A |
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0713111A |
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0801111A |
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0822111A |
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0921111A |
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1005111A |
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0615111A |
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0725111A |
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0808111A |
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0822111B |
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0923111A |
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1006111A |
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0620111A |
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0726111A |
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0809111A |
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0823111A |
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0923111B |
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0621111A |
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0726111B |
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0810111A |
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0823111B |
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0924111A |
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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
Posted by Sean Fenske, Editor-in-Chief, MDT
