ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loo
FDA device recall Z-0568-2024 · posted 2023-12-15 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
- 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.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- FAS
- Quantity affected
- 162 pieces (27 boxes, 6 per box)
- Distribution
- US: AL, FL, GA, KS, LA, MD, MI, NC, NJ, NY, TX, WI & WV and Canada.
- Date initiated
- 2023-10-02
- Date posted
- 2023-12-15
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADULT RESECTOSCOPE (K890328) | Circon Video | 1990-02-06 |