HydroMID Maximal Barrier Kit recallZ-1156-2023 · Access Vascular, Inc · initiated Dec 22, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Access Vascular, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Label with the incorrect component listed on the inner kit Tyvek header bag
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1156-2023
- Status
- Open, Classified
- Initiated by the company
- Dec 22, 2022
- Posted by the FDA
- Feb 22, 2023
- Recalling firm
- Access Vascular, Inc
- Quantity
- 445 units
- Product code
- FOZ
- FDA submissions
- K203069
- Distribution
- US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
Product description
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
Code information (models, lots, serial numbers)
UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HydroMID Maximal Barrier Kit 80004004Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2 recalls5 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K203069 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HydroMID Basic Kit 80004002Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1 recall0 reports
- HydroMID MID-141Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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