Z-2446-2010

Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use...

Name: Z-2446-2010 Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use...
Creator: Chalgren Enterprises Inc
Published: 2007-04-12
License: https://open.fda.gov/license/

Chalgren Enterprises, Inc. / initiated 2007-04-12 / Terminated / root cause: packaging

FDA source

Chalgren Enterprises Inc began a recall of Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc... on 2007-04-12. The reason FDA records is "Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2446-2010
Status: Terminated
Initiated: 2007-04-12
Posted: 2010-09-21
Terminated: 2011-03-24
Recalling firm: Chalgren Enterprises, Inc.
Product: Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.
Product code: IKT Electrode, Needle, Diagnostic Electromyograph
Reason for recall: Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.
Root cause tag: packaging
FDA root cause: Packaging
Action: Chalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution.
Distribution: Nationwide Distribution: USA states of CA, IL, NJ, OH and TX.
Product codes and lots: Lot number P059

Product code IKT

K912283Class IIDetachable, Disposable Monopolar Needle ElectrodeChalgren Enterprises, Inc. / cleared 1992-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)