FDA-Device2025-07-30Class II
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
Olympus Corporation of the Americas
Hazard
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Sold states
International distribution to the country of Japan.
Affected count
41 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2140-2025Don't want to check this manually?
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