HydroPICC Maximal Barrier Kit recallZ-1605-2023 · Access Vascular, Inc · initiated Mar 3, 2023
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
The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
FDA root cause category: Labeling mix-ups
What the company is doing
An "Urgent Medical Device Correction" notification letter was sent to customers on 3/3/23. Our records indicate that your facility has received kits from the affected lots. We are contacting you to provide information on action to take to ensure patient safety. - Product that has already been used: No action required. The catheter and all kit components are currently within their expiration date, so no patient safety risk has been identified. - Product that has not been used: The catheter and all kit components are currently, within their expiration date, so no immediate patient safety risk has been identified. However, please refrain from using these kits as using the product used past its expiration date may contaminate the sterile field and result in an infection. AVI will provide a replacement label with the correct expiration date or replace the affected products. Access Vascular is committed to providing the highest quality products and support and is implementing corrective actions to prevent this issue from recurring in the future. We apologize for any inconvenience this may cause you and appreciate your understanding as we take steps to correct this issue. If you have any questions about this communication, please contact us at 781-538-6594.
Recall details
- Recall number
- Z-1605-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 3, 2023
- Posted by the FDA
- May 18, 2023
- Recalling firm
- Access Vascular, Inc
- Quantity
- 240 units
- Product code
- LJS
- FDA submissions
- K193015
- Distribution
- US distribution to States of: FL, TN, TX.
Product description
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Code information (models, lots, serial numbers)
UDI-DI: 00862559000487; Lot Number: 11423949
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HydroPICC Maximal Barrier Kit 80001004Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall7 reports
Product lines
Other devices under the same FDA submission
7 devices cleared under K193015 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- HydroPICC PICC-142Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall4 reports
- HydroPICC Basic Kit (80cm GW) 80001002Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall1 report
- HydroPICC Basic Kit (130cm GW) 80001001Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days1 recall0 reports
- HydroPICC Maximal Barrier Kit 80H01104Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days9 reports
- HydroPICC Basic Kit (70cm GW) 80H01102Access Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2 reports
- HydroPICC Catheter PICC-142CMAccess Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2 reports
- HydroPICC PICC-142SAccess Vascular, Inc. · Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2 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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