ACMI Roller Bar Electrodes Recall Due to Incorrect Pouch Labeling

Plain-English summary

Olympus Corporation of the Americas is recalling ACMI Roller Bar Electrodes, Model REF RB, due to incorrect pouch labels. The product is packaged in boxes of 6 pouches. Some pouches are labeled as ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized (Model REF MLE 24-012), but the actual contents are Roller Bar Electrodes. A total of 162 pieces (27 boxes) have been affected.

The incorrect pouch label could create confusion during clinical use if practitioners rely on the individual pouch label rather than the correct box label. The affected product was distributed to customers in Alabama, Florida, Georgia, Kansas, Louisiana, Maryland, Michigan, North Carolina, New Jersey, New York, Texas, Wisconsin, and West Virginia, as well as Canada.

The FDA has classified this as a Class II recall. No illnesses or injuries have been reported to date. Healthcare facilities and practitioners who have received affected product should verify the contents of individual pouches against the correct box label before clinical use. Contact Olympus Corporation of the Americas for product replacement or additional information.

The recalled product

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

Manufacturer

Olympus Corporation of the Americas

Category

Medical Device — Surgical Electrodes

Hazard

• mis-labeling

Distribution

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