FDA Medical Device Recalls (openFDA)
Access Vascular, Inc: HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
- Recall number
- Z-1605-2023
- Recalling firm
- Access Vascular, Inc
- Product
- HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
- Status
- Open, Classified
- Initiated
- 2023-03-03
- Posted
- 2023-05-18
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Labeling mix-ups
- Action
- 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.
- Quantity
- 240 units
- Distribution
- US distribution to States of: FL, TN, TX.
- Lot, serial or model codes
- UDI-DI: 00862559000487; Lot Number: 11423949
- 510(k) numbers
- ["K193015"]
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 3021570645
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28