Recall Z-2324-2021— Ortho8, Inc.

Name: FDA recall Z-2324-2021
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: CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,. Reason: CIRCUL8 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

CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,

Reason for recall

CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

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