Recall Z-1155-2023 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Access Vascular, Inc
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
| Date | Feb 22, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| Reason | Product Mislabeled on the outer bag and inner kit Tyvek header bag |
| Root cause | Under Investigation by firm |
| Action | Access Vascular issued letter to customers on 22 DEC 2022. Letter states reason for recall, health risk and action to take: please refrain from using these kits as additional kit components may be required may cause an inconvenient in completing the procedure. AVI will provide a replacement label with the correct contents or replace the product. The following page identifies the shipments you have received with these impacted lots. Please forward this notice in the event the affected product was further distributed. We will contact you to identify the number of kits that are currently in your |
| Quantity | 155 units |
| Distribution | US Nationwide distribution in the states of FL, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203069 | HydroMID Access Vascular, Inc., Feb 8, 2021 |