Z-1605-2023Class II

HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

Name: Z-1605-2023 HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Creator: Access Vascular, Inc
Published: 2023-03-03
License: https://open.fda.gov/license/

Access Vascular, Inc / initiated 2023-03-03 / Open, Classified / root cause: labeling and UDI

FDA source

Access Vascular, Inc began a recall of HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 on 2023-03-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1605-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-03
Posted: 2023-05-18
Recalling firm: Access Vascular, Inc
Product: HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 240 units
Distribution: US distribution to States of: FL, TN, TX.
Product codes and lots: UDI-DI: 00862559000487; Lot Number: 11423949

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1605-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1605-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-24	2023-05-18

Product code LJS

K193015Class IIHydroPICC (PICC-142)Access Vascular, Inc. / cleared 2020-02-20

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)