Ortho8, Inc. recalls CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only,…
- Recall date
- July 9, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2324-2021
- FDA classification
- Class II
- Brand / firm
- Ortho8, Inc.
- Sold / distributed
- 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.
Why it was recalled
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
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