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 (8

Hazard

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

Details from the source

Reason for recall: Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. Distribution: US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada. Quantity: 162 pieces (27 boxes, 6 per box) 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

UPC codes

00821925036413, 00821925036444

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.