FDA recall Z-2579-2021

Product

PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13

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-2579-2021