Recall Z-2446-2010 ยท IKT Electrode, Needle, Diagnostic Electromyograph
Chalgren Enterprises Inc
Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.
| Date | Sep 21, 2010 (initiated Apr 12, 2007) |
| Status | Terminated |
| Reason | Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility. |
| Root cause | Packaging |
| Action | Chalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution. |
| Distribution | Nationwide Distribution: USA states of CA, IL, NJ, OH and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912283 | DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE Chalgren Enterprises, Inc., Mar 16, 1992 |