FDA-Device2021-10-06Class II
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Aesculap Implant Systems LLC
Hazard
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
Sold states
US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Affected count
80 units
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2578-2021Don't want to check this manually?
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