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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'.
Product is non-sterile but labeled incorrectly as sterile.
Surgical camera control units were not designed and manufactured to pass the IEC 60101 testing for electrical fast transients (EFT)