Recall Z-0997-2023— Bolton Medical Inc.

Name: FDA recall Z-0997-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-20

Class II · Ongoing

Class II FDA medical device recall by Bolton Medical Inc., initiated 2022-12-20. Product: RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX. Reason: The product may be shorter than packaging indicates.

Recalling firm: Bolton Medical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-20
Firm location: Sunrise, FL, United States

Product description

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

Reason for recall

The product may be shorter than packaging indicates

Data sourced from openFDA. This site is unofficial and independent of the FDA.