PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: January 25, 2023 Initiated: December 20, 2022 #Z-0997-2023

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

Details

Recalling Firm
Bolton Medical Inc.
Units Affected
129 units
Distribution
Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.
Location
Sunrise, FL

Frequently Asked Questions

What product was recalled?
RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX. Recalled by Bolton Medical Inc.. Units affected: 129 units.
Why was this product recalled?
The product may be shorter than packaging indicates
Which agency issued this recall?
This recall was issued by the FDA Devices on January 25, 2023. Severity: Moderate. Recall number: Z-0997-2023.