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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Detachable Monopolar Needle Electrode for EMG

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 Class 2 Device Recall Disposable Detachable Monopolar Needle Electrode for EMGsee related information
Date Initiated by FirmApril 12, 2007
Date PostedSeptember 21, 2010
Recall Status1 Terminated 3 on March 24, 2011
Recall NumberZ-2446-2010
Recall Event ID 56183
510(K)NumberK912283 
Product Classification Electrode, needle, diagnostic electromyograph - Product Code IKT
ProductDisposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.
Code Information Lot number P059
FEI Number 2939713
Recalling Firm/
Manufacturer		 Chalgren Enterprises Inc
380 Tomkins Ct
Gilroy CA 95020-3631
For Additional Information Contact
408-847-3994
Manufacturer Reason
for Recall		Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.
FDA Determined
Cause 2		Packaging
ActionChalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution.
DistributionNationwide Distribution: USA states of CA, IL, NJ, OH and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IKT
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