CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Reported: August 25, 2021 Initiated: July 9, 2021 #Z-2324-2021
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
Details
- Recalling Firm
- Ortho8, Inc.
- Units Affected
- N/A
- Distribution
- 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.
- Location
- Rocklin, CA
Frequently Asked Questions
What product 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,. Recalled by Ortho8, Inc.. Units affected: N/A.
Why was this product recalled? ▼
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2324-2021.
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