Z-1129-2023Class II

HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

Name: Z-1129-2023 HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Creator: Access Vascular, Inc
Published: 2022-12-16
License: https://open.fda.gov/license/

Access Vascular, Inc / initiated 2022-12-16 / Open, Classified / root cause: labeling and UDI

FDA source

Access Vascular, Inc began a recall of HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 on 2022-12-16. FDA classified it as Class II and gives the reason as "Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit". 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-1129-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-16
Posted: 2023-02-10
Recalling firm: Access Vascular, Inc
Product: HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Root cause tag: labeling and UDI
FDA root cause: Incorrect or no expiration date
Action: Urgent Medical Device Correction notification letters were sent to customers beginning 12/16/22.. Access Vascular has identified that 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. These catheters are individually packaged and supplied sterile along with a sterile kit. 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. The following page identifies the shipments you have received with these impacted lots. 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. 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: 1,789 HydroMID devices
Distribution: US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
Product codes and lots: UDI-DI: (01)00850030354006; Lot Number: 11428361, 11393260, 11395226

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1129-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1130-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10
Z-1131-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-22	2023-02-10

Product code FOZ

K203069Class IIHydroMIDAccess Vascular, Inc. / cleared 2021-02-08

MDM coverage of this record lists here, newest first.

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)