Home / Recalls / Ortho8, Inc. / Z-2324-2021

Z-2324-2021 Class II Ongoing

Recalled by Ortho8, Inc. — Rocklin, CA

FDA device recall Z-2324-2021 was initiated by Ortho8, Inc. on July 9, 2021 and is designated Class II. Reason for recall: CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance The recall status is ongoing. Affected quantity: N/A.

Recall Details

Product Type: Devices
Report Date: August 25, 2021
Initiation Date: July 9, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

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

Distribution Pattern

US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.

Code Information

All Lots