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Terminated

AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B

FDA Recall Z-0470-03 · Posted 2003-01-30

Recalling FirmEncision, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2003-01-15
Date Terminated2003-04-14
Product Quantity58 devices.

Reason for Recall

Reports of needle fixed-tip electrodes becoming loose or breaking off.

Firm Action

All consignees will be notified by phone or visit beginning 01/15/2003.

Root Cause

Other

Distribution Pattern

Domestic distribution to LA, MA, MN, OR, UT and WA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912780MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELDElectroscope, Inc. · 1991-12-30

Official Source

View FDA Recall →

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

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