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Terminated

Rocker Switch Electrosurgical Pencil with E-Z Clean Tip

FDA Recall Z-0778-06 · Posted 2006-04-19

Recalling FirmMegadyne Medical Products, Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2006-04-06
Date Terminated2006-08-03
Product Quantity34,132 units

Reason for Recall

Surgical device packaging may be damaged and may compromise sterility.

Firm Action

Consignees were notified by letter on 04/06/2006.

Root Cause

Other

Distribution Pattern

Nationwide, including one VA facility in OH. No military consignees. Foreign distribution to France, India, Ireland, Japan, South Korea, Malaysia, Poland, UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K965054PENCILMegadyne Medical Products, Inc. · 1997-01-24

Official Source

View FDA Recall →

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

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