CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, N
Summary
The FDA issued a Class II for CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosi by Ortho8, Inc.. Reason: CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance.
Details
Source
Device Recall
External ID
Z-2324-2021
Action Date
2021-08-25
Status
Ongoing
Category
device
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,
Lot/Code Info: All Lots
Quantity Affected: N/A
Reason for Recall
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-09
Company
Rocklin, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho8, Inc. has 5 FDA actions in our database, including 2 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho8, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho8, Inc. have FDA actions?
Ortho8, Inc. has 5 FDA actions in our database, including 2 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2324-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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