VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only. Manufactured in the U.S.A. for VI
FDA device recall Z-1254-06 · posted 2006-07-25 · Terminated
Recall details
- Recalling firm
- Nicolet Biomedical Div of Viasys Healthcare
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GXZ
- Quantity affected
- 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
- Date initiated
- 2006-04-28
- Date posted
- 2006-07-25
- Date terminated
- 2006-12-27
- Location
- Madison, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERILE SUBDERMAL NEEDLE ELECTRODES (K010019) | Nicolet Biomedical, Inc. | 2001-03-19 |