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
This recall has been terminated (originally issued July 25, 2006).
- Recall Initiated
- April 28, 2006
- Posted
- July 25, 2006
- Terminated
- December 27, 2006
- Recall Number
- Z-1254-06
- Quantity
- 53 boxes, 10 electrodes per pouch, 10 pouches per box
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
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.
Distribution
World wide including the states of AL, CA, CT, FL, IA, NH, NY, OH, TX. and countries of Canada, Japan, Poland
Lot / Code Info
Lot 604664
Root Cause
Other
Action Taken
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.