Z-1254-06

VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the...

Name: Z-1254-06 VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the...
Creator: Nicolet Biomedical Div of Viasys Healthcare
Published: 2006-04-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2006-04-28 / Terminated / root cause: manufacturing process

FDA source

Nicolet Biomedical Div of Viasys Healthcare began a recall of 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... on 2006-04-28. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1254-06
Status: Terminated
Initiated: 2006-04-28
Posted: 2006-07-25
Terminated: 2006-12-27
Recalling firm: Medtronic, Inc.
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
Product code: GXZ Electrode, Needle
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.
Root cause tag: manufacturing process
FDA root cause: Other
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.
Quantity in commerce: 53 boxes, 10 electrodes per pouch, 10 pouches per box
Distribution: World wide including the states of AL, CA, CT, FL, IA, NH, NY, OH, TX. and countries of Canada, Japan, Poland
Product codes and lots: Lot 604664

Product code GXZ

K010019Class IISterile Subdermal Needle ElectrodesNicolet Biomedical, Inc. / cleared 2001-03-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)