Recall Z-1155-2023
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 Model Number: 80004004
Codes / lots: UDI: (01)00850030354020 Lot Number: 11434018
Reason for recall
Product Mislabeled on the outer bag and inner kit Tyvek header bag
FDA-determined cause: Under Investigation by firm
Action taken
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 inventory and determine the appropriate correction with your input, in a timely manner. you have any questions about this communication, please contact us at 781-538-6594.
Details
- Recall number
- Z-1155-2023
- Initiated
- December 22, 2022
- Posted by FDA
- February 22, 2023
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Quantity
- 155 units
- Distribution
- US Nationwide distribution in the states of FL, TX, WA.
- Recalling firm
- Access Vascular, Inc, Billerica, MA