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Ortho8, Inc. recalls CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, N
Recalled August 25, 2021 · FDA recall Z-2324-2021 · Ortho8
Hazard
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance · FDA Class II
Units
N/A
Sold at
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.
Description
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
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,
Manufacturer(s)
Ortho8, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →