FDA recall Z-1019-2022

Product

Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.

Reason for recall

There is a potential for foreign matter.

Distribution

Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom

Key facts

Status

Ongoing

Initiation date

2022-04-01

Report date

2022-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2022