FDA recall Z-2578-2021

Aesculap Implant Systems LLC · Class II · device

Product

PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

Reason for recall

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

Distribution

US Nationwide distribution in the states of FL, MI, NY, TX, WI.

Key facts

Status: Terminated
Initiation date: 2021-04-16
Report date: 2021-10-06
Termination date: 2023-01-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2578-2021