Recall Z-0568-2024
Olympus Corporation of the Americas · initiated October 2, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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,
Codes / lots: UDI-DI: 00821925036413 (Incorrect Right Angle Cutting Loop pouch label) UDI-DI: 00821925036444 (Correct on Roller Bar Electrode box label) Lot: KR260855
Reason for recall
Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-0568-2024
- Initiated
- October 2, 2023
- Posted by FDA
- December 15, 2023
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- 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.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA