Recall Z-1156-2023 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 Number: 80004004
| Date | Feb 22, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| Reason | Label with the incorrect component listed on the inner kit Tyvek header bag |
| Root cause | Under Investigation by firm |
| Action | Access Vascular issued Urgent Medical Device Correction-HydroMID Labeling on 12/22/22. Letter states reason for recall, health risk and action to take: Product that has already been used: No action required. There is no patient safety risk has been identified. - Product that has not been used: The kit labeling identified components which are not included in the kit, however there is no immediate patient safety risk. However, 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 lab |
| Quantity | 445 units |
| Distribution | US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203069 | HydroMID Access Vascular, Inc., Feb 8, 2021 |