FDA recall Z-0997-2023

Product

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX

Reason for recall

The product may be shorter than packaging indicates

Distribution

Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.

Key facts

Status

Ongoing

Initiation date

2022-12-20

Report date

2023-01-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunrise, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0997-2023