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Terminated

Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.

FDA Recall Z-2446-2010 · Posted 2010-09-21

Recalling FirmChalgren Enterprises Inc
Recall StatusTerminated
Product CodeIKT
Date Initiated2007-04-12
Date Terminated2011-03-24

Reason for Recall

Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.

Firm Action

Chalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution.

Root Cause

Packaging

Distribution Pattern

Nationwide Distribution: USA states of CA, IL, NJ, OH and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912283DETACHABLE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODEChalgren Enterprises, Inc. · 1992-03-16

Official Source

View FDA Recall →

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

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