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U.S. Department of Health and Human Services

Class 2 Device Recall EVEXIA LUXE DVT PREVENTION DEVICE

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 Class 2 Device Recall EVEXIA LUXE DVT PREVENTION DEVICEsee related information
Date Initiated by FirmJuly 09, 2021
Create DateAugust 19, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2325-2021
Recall Event ID 88308
Product Classification Sleeve, limb, compressible - Product Code JOW
ProductEVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
Code Information All Lots
Recalling Firm/
Manufacturer
Ortho8, Inc.
2217 Plaza Dr
Rocklin CA 95765-4421
For Additional Information ContactCustomer Service
888-257-7908
Manufacturer Reason
for Recall
EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
FDA Determined
Cause 2
Unknown/Undetermined by firm
ActionOn July 19, 2021 Ortho8 Inc. issued a "Urgent Medical Device Recall" notification to all affected consignees and users via UPS. In addition to informing consignees/users about the recalled device the firm asked consignees to take the following actions: Consignees: 1. Ortho8 is requiring the immediate return all remaining inventory of Evexia" & Circul8 Luxe devices. All consignees are asked to quarantine and discontinue use of the Evexia" and Circul8 Luxe devices. 2. This recall notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. If your firm distributed the devices to other distributors, you are asked to provide your customers with a copy of this recall notification. If your firm distributed the devices to patients, you are asked to provide these patients with a copy of this recall notification and let them know Ortho8 will replace their device with a Circul8 Pro, a DVT prevention device that has been cleared for marketing by the U.S. FDA. 3. Please complete & return the enclosed acknowledgment form no later than July 30, 2021 and indicate the number of devices being returned Patients: 1. Our records show you received one of these devices. 2. Ortho8 will replace your device with a Circul8 Pro, a DVT prevention device that has been cleared for marketing by the U.S. FDA. 3. We ask that you complete the enclosed acknowledgement form and return to us no later than July 30, 2021. This acknowledgment form will let us know to send you a replacement device. When we send your replacement device, we will also send you a prepaid, addressed package for returning your Evexia" or Circul8 Luxe. 4. Replacement devices will be available to you through September 30, 2021. 5. Meanwhile, consult your physician on identifying other comparable devices to use until your replacement device arrives.
DistributionUS 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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