Device 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,
Z-2324-2021
Product summary
- Firm
- Ortho8, Inc.
- Event
- Event 88308
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2324-2021
Official wording
Reason: CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Code information: All Lots
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.
Derived failure modes
-
Unknown
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance