—#204303

Product

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,

FDA product code: FAS — Electrode, Electrosurgical, Active, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K890328
Affected lot / code info: UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855

Why it was recalled

Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.

Timeline

Recall initiated: 2023-10-02
Posted by FDA: 2023-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204303. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.