Recall Z-1048-2022 ยท EOQ Bronchoscope (Flexible Or Rigid)
Olympus Corporation of the Americas
BF-MP160F: EVIS EXERA Bronchofibervideoscope
| Date | Mar 8, 2022 |
| Status | Open, Classified |
| Reason | Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization |
| Root cause | Other |
| Action | Olympus issued Urgent Medical Device Correction Letters on 3/8/22. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. 2. Carefully read the content of this Medical Device Correction Action as well as the attached Addendum . The addendum provides updated information or instructions on the chemicals to be used for reprocessing, the sterilization conditions, rinsing after |
| Quantity | 292 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033225 | EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT Olympus Optical Co., Ltd., Oct 16, 2003 |