Recall Z-2325-2021— Ortho8, Inc.

Name: FDA recall Z-2325-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-09

Class II · Ongoing

Class II FDA medical device recall by Ortho8, Inc., initiated 2021-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile. Reason: EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance.

Recalling firm: Ortho8, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-07-09
Firm location: Rocklin, CA, United States

Product description

EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile

Reason for recall

EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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