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U.S. Department of Health and Human Services

Class 3 Device Recall AccuGuide

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  Class 3 Device Recall AccuGuide see related information
Date Initiated by Firm January 22, 2007
Date Posted March 07, 2007
Recall Status1 Terminated 3 on July 07, 2012
Recall Number Z-0576-2007
Recall Event ID 37298
510(K)Number K990793  
Product Classification Surface electrodes - Product Code GZX
Product AccuGuide Injection Needles (Surface electrodes)

The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface electrodes that are packaged 2 per non-breathable pouch, but are not sterilized.
Code Information Lot Numbers: 45648300, 46526000, 46709500, 48166300
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
Manufacturer Reason
for Recall		 A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.
FDA Determined
Cause 2		 Other
Action Each consignee contacted via telephone 01/22/2007, and then sent a follow-up fax letter 02/02/2007, which explained the issue, and the options for dispositioning any product that they still had in stock. Since firm has determined that the risk of keeping and using these devices is negligible to no risk, as they are intended to be and typically used in a non-sterile manner, the firm is offering the consignees the option to keep their devices or have them replaced.
Quantity in Commerce 48 boxes
Distribution Nationwide
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GZX and Original Applicant = MEDTRONIC XOMED
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