Recall Z-2324-2021 ยท JOW Sleeve, Limb, Compressible
Ortho8, Inc.
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
| Date | Jul 9, 2021 |
| Status | Open, Classified |
| Reason | CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance |
| Root 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 wh |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.