Access Vascular, Inc HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Brand
Access Vascular, Inc
Lot Codes / Batch Numbers
UDI-DI: 00862559000487, Lot Number: 11423949
Products Sold
UDI-DI: 00862559000487; Lot Number: 11423949
Access Vascular, Inc is recalling HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 due to 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 p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
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 noticeDistribution
As reported by FDA
FL, TN, TX
Page updated: Jan 10, 2026