FDA-Device2023-12-27Class II
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,
Olympus Corporation of the Americas
Hazard
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
Sold states
US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.
Affected count
162 pieces (27 boxes, 6 per box)
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0568-2024Don't want to check this manually?
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