Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.
FDA device recall Z-3097-2011 · posted 2011-08-30 · Terminated
Recall details
- Recalling firm
- Encision, Inc.
- Reason for recall
- Electrode tips have been reported breaking off during use or cleaning.
- Action taken
- Encision Inc. sent out an "Urgent Product Recall" letter dated August 24, 2011 to all affected customers. The letter included: affected product, problem and instructed customers to discontinue use and return all affected electrodes to Encision. An enclosed reply form was to be faxed back to Encision indicating status of firm's inventory. For information on this recall call Encision at (303) 339-6917.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
- Date initiated
- 2011-08-24
- Date posted
- 2011-08-30
- Date terminated
- 2012-09-04
- Location
- Boulder, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SUCTION IRRIGATION ELECTRODES AND ADAPTERS (K100711) | Encision, Inc. | 2010-06-09 |