The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
Reason for recall: The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination. Distribution: US Nationwide. Global Distribution Quantity: 3001 units Lot/code info: Lot Number: All units sold prior to 2023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.