Reported Aug 25, 2021 · Ongoing
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only,…
Ortho8, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho8, Inc. · 2217 Plaza Dr · Rocklin, CA · 95765-4421
Is this the product you have?
- CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis
- REF08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free
- Lot codes and dates
- All Lots
- Amount recalled
- N/A
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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