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Recall Observatory FDA recall evidence

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

July 09, 2021

Class II

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

    reason.no_named_rule · v1.0.0

    CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance