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Terminated

Encision AEM Suction Irrigation Electrode, L-Hook, REF ES3883, Encision Inc., Boulder, CO 80301. The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.

FDA Recall Z-3095-2011 · Posted 2011-08-30

Recalling FirmEncision, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2011-08-24
Date Terminated2012-09-04
Product Quantity212 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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