Nicolet Biomedical Div of Viasys Healthcare VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches of Bar Electrodes and each pouch contains 10 electrodes Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VIASYS Healthcare, 5225 Verona Road, Bldg 2, Madison, WI USA 53711-4495..Each box contains 10 pouches of Bar Electrodes and each pouch contains 10 electrodes
Brand
Nicolet Biomedical Div of Viasys Healthcare
Lot Codes / Batch Numbers
Lot 604664
Products Sold
Lot 604664
Nicolet Biomedical Div of Viasys Healthcare is recalling VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactur due to The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a motor or sensory nerve action potential. These possible lower amplitudes will be measured only if the bar electrode is used as a bar.
Recommended Action
Per FDA guidance
Communication on April 28, 2006 by phone, followed by Certified Mail, with return receipt to confirm receipt of information . The letter describes the issue and asks that affected product be returned. The customer notification allows the user the option of using the Bar Electrode as 2 separate electrodes, as described in the Instructions for Use.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, CT, FL, IA, NH, NY, OH, TX
Page updated: Jan 10, 2026