Ortho8, Inc. Recall 88308
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,
Ortho8, Inc. Recall 88308 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2324-2021 |
| Event ID | 88308 |
| Event 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, |
| Product Type | Devices |
| 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. |
| Recall Reason | CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance |
| Device Classification | 20210825 |
| Device Code Info | All Lots |
| Center Classification Date | 20210819 |
| Recall Initiation Date | 20210709 |
| Recalling Firm | Ortho8, Inc. |
| Initial Notification | Letter |
| Similar To |