Olympus M3 Gold Autoclavable Lateral Telescope 70 recalled for sterilization parameter discrepancies
What this means
Olympus has identified differences between the sterilization instructions in the U.S. Instructions for Use and those in the Japanese package insert for the M3 Gold Autoclavable Lateral Telescope 70 (model M3-70A). This discrepancy could lead to improper sterilization if the wrong parameters are followed. The device was distributed internationally, with 50 units affected.
- If you use or manage an M3-70A telescope, verify you are following the correct sterilization parameters for your region.
- Contact Olympus Corporation of the Americas for clarification on the correct sterilization instructions for your device.
The agency's original wording
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3300-2026More Olympus recalls
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