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
FDA Recall Z-1254-06 · Posted 2006-07-25
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Recalling FirmNicolet Biomedical Div of Viasys Healthcare
Recall StatusTerminated
Product CodeGXZ
Date Initiated2006-04-28
Date Terminated2006-12-27
Product Quantity53 boxes, 10 electrodes per pouch, 10 pouches per box
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
World wide including the states of AL, CA, CT, FL, IA, NH, NY, OH, TX. and countries of Canada, Japan, Poland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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