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Terminated

Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.

FDA Recall Z-3097-2011 · Posted 2011-08-30

Recalling FirmEncision, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2011-08-24
Date Terminated2012-09-04
Product Quantity10 units

Reason for Recall

Electrode tips have been reported breaking off during use or cleaning.

Firm Action

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

Distribution Pattern

Worldwide Distribution: Nationwide distribution, and the country of New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100711SUCTION IRRIGATION ELECTRODES AND ADAPTERSEncision, Inc. · 2010-06-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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