FDA recall Z-0782-2021

Product

Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Reason for recall

The cylindrical sponge component is not x-ray detectable.

Distribution

Foreign distribution only - Canada.

Key facts

Status

Terminated

Initiation date

2020-11-13

Report date

2021-01-13

Termination date

2021-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0782-2021