Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.
This recall has been terminated (originally issued August 30, 2011).
- Company
- Encision, Inc.
- Recall Initiated
- August 24, 2011
- Posted
- August 30, 2011
- Terminated
- September 4, 2012
- Recall Number
- Z-3097-2011
- Quantity
- 10 units
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Electrode tips have been reported breaking off during use or cleaning.
Distribution
Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
Lot / Code Info
Catalog: REF ES3885. Lots: QI and RA.
Root Cause
Device Design
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.
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