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