Recall Z-1156-2023
Access Vascular, Inc · initiated December 22, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076
Reason for recall
Label with the incorrect component listed on the inner kit Tyvek header bag
FDA-determined cause: Under Investigation by firm
Action taken
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 label with the correct contents or replace the product. 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 inventory and determine the appropriate correction with your input, in a timely manner. If you have any questions about this communication, please contact us at 781-538-6594.
Details
- Recall number
- Z-1156-2023
- Initiated
- December 22, 2022
- Posted by FDA
- February 22, 2023
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Quantity
- 445 units
- Distribution
- US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
- Recalling firm
- Access Vascular, Inc, Billerica, MA