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Terminated

AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.

FDA Recall Z-1074-04 · Posted 2004-09-22

Recalling FirmEncision, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2004-06-11
Date Terminated2004-11-09
Product Quantity335 units

Reason for Recall

Electrosurgical tip may break or come off during use.

Firm Action

Customers were notified beginning 6/15/2004 by phone or visit.

Root Cause

Other

Distribution Pattern

AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.

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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