Recall Z-2423-2021 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Olympus Corporation of the Americas
Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy
| Date | Aug 3, 2021 |
| Status | Terminated |
| Reason | Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection. |
| Root cause | Equipment maintenance |
| Action | Olympus Own Label Distributor US issued letter 8/3/21 via UPS Ground, letter states reason for recall, health risk and action to take: Olympus requires you to take the following immediate action: 1. Carefully read the content of this Field Safety Notice. 2. Below are examples of a gap in the seal between the lid and the plastic package 3. As per the instructions for use, do not use if packaging is damaged. If you observe this packaging anomaly or any other damage to the packaging, immediately cease any further use of any affected product you have, remove it from your inventory and quarantine i |
| Quantity | 711,157 units units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151801 | Arc Endocuff Vision Boddingtons Plastics, Ltd., Aug 13, 2015 |