Recall Z-0568-2024 ยท FAS Electrode, Electrosurgical, Active, Urological
Olympus Corporation of the Americas
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,
| Date | Dec 15, 2023 (initiated Oct 2, 2023) |
| Status | Open, Classified |
| Reason | Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. |
| Root cause | Labeling Change Control |
| Action | An Urgent Medical Device Recall notice, issued via UPS Ground October 27, 2023, advises customers of the mislabeled product pouches. Customers are to examine and quarantine any affected inventory, contact Olympus customer service to arrange for return/replacement, and forward notice to any facility where product was further distributed. Acknowledge receipt of the recall notice through the Olympus recall portal at https://olympusamerica.com/recall (enter recall number "0432"). Customers requiring additional information may contact Cynthia.Ow@olympus.com. |
| Quantity | 162 pieces (27 boxes, 6 per box) |
| Distribution | US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K890328 | ADULT RESECTOSCOPE Circon Video, Feb 6, 1990 |