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Terminated

Hyfrecator 20)0 Electrosurgical Unit. Hyfrecator 2000, P/N 7-900-XXX (where XXX may equal -100, -115, -220 and -230.

FDA Recall Z-0144-04 · Posted 2003-11-19

Recalling FirmConMed Electrosurgery
Recall StatusTerminated
Product CodeGEI
Date Initiated2003-09-15
Date Terminated2004-07-01
Product Quantity10 units

Reason for Recall

The Hyfrecator 2000 units were released without documented adherence to their voltage output specification.

Firm Action

All customers were notified by certified letter on 9/15/03. Mailing to the Phillipines by registered mail also on 9/15/03. Firm requests that the units be returned for testing or the replacement with another unit.

Root Cause

Other

Distribution Pattern

Units were distributed to CA, CT,IL and ME. International distribution to Phillipines.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970493HYFRECATOR 2000Aspen Labs · 1997-04-30

Official Source

View FDA Recall →

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

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