FDAJuly 9, 2021device
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
What to do
FDA enforcement status: Ongoing
Brands named
ortho8
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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