Recall Z-1254-06 ยท GXZ Electrode, Needle
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
| Date | Jul 25, 2006 (initiated Apr 28, 2006) |
| Status | Terminated |
| Reason | 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 | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010019 | STERILE SUBDERMAL NEEDLE ELECTRODES Nicolet Biomedical, Inc., Mar 19, 2001 |