AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
FDA device recall Z-0470-03 · posted 2003-01-30 · Terminated
Recall details
- Recalling firm
- Encision, Inc.
- Reason for recall
- Reports of needle fixed-tip electrodes becoming loose or breaking off.
- Action taken
- All consignees will be notified by phone or visit beginning 01/15/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 58 devices.
- Distribution
- Domestic distribution to LA, MA, MN, OR, UT and WA.
- Date initiated
- 2003-01-15
- Date posted
- 2003-01-30
- Date terminated
- 2003-04-14
- Location
- Boulder, CO
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD (K912780) | Electroscope, Inc. | 1991-12-30 |