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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Access Vascular, Inc
Lot Codes / Batch Numbers
UDI: (01)00850030354020 Lot Number: 11434018
Products Sold
UDI: (01)00850030354020 Lot Number: 11434018
Access Vascular, Inc is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the pe due to Product Mislabeled on the outer bag and inner kit Tyvek header bag. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026