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Terminated

Megadyne MegaTip, E-Z Clean Non Stick Cautery Tip, CAT/REF 0600, Single Use Only, STERILE

FDA Recall Z-0468-03 · Posted 2003-01-30

Recalling FirmMegadyne Medical Products, Inc
Recall StatusTerminated
Product CodeGEI
Date Initiated2002-12-20
Date Terminated2003-09-05
Product Quantity19464

Reason for Recall

The metal substrate cautery tip may break during use.

Firm Action

On 12/20/2002, all consignees were notified by letter to return all affected product.

Root Cause

Other

Distribution Pattern

Nationwide. Foreign distribution to Australia, Belgium, Canada, Italy, Korea, New Zealand, Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K943055ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIESMegadyne Medical Products, Inc. · 1994-12-21

Official Source

View FDA Recall →

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

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