Class 2 Device Recall CIRCUL8 LUXE DVT PREVENTION DEVICE

• Date Initiated by Firm: July 09, 2021
• Create Date: August 19, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2324-2021
• Recall Event ID: 88308
• Product Classification: Sleeve, limb, compressible - Product Code JOW
• 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,
• Code Information: All Lots
• Recalling Firm/ Manufacturer: Ortho8, Inc.; 2217 Plaza Dr; Rocklin CA 95765-4421
• For Additional Information Contact: Customer Service; 888-257-7908
• Manufacturer Reason for Recall: CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: On 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.
• 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.
• Total Product Life Cycle: TPLC 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.