Z-1156-2023Class II

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral...

Name: Z-1156-2023 HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral...
Creator: Access Vascular, Inc
Published: 2022-12-22
License: https://open.fda.gov/license/

Access Vascular, Inc / initiated 2022-12-22 / Open, Classified / root cause: labeling and UDI

FDA source

Access Vascular, Inc began a recall of HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product... on 2022-12-22. FDA classified it as Class II and gives the reason as "Label with the incorrect component listed on the inner kit Tyvek header bag". 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-1156-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-22
Posted: 2023-02-22
Recalling firm: Access Vascular, Inc
Product: HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Label with the incorrect component listed on the inner kit Tyvek header bag
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Access Vascular issued Urgent Medical Device Correction-HydroMID Labeling on 12/22/22. Letter states reason for recall, health risk and action to take: Product that has already been used: No action required. There is no patient safety risk has been identified. - Product that has not been used: The kit labeling identified components which are not included in the kit, however there is no immediate patient safety risk. However, please refrain from using these kits as additional kit components may be required may cause an inconvenient in completing the procedure. AVI will provide a replacement label with the correct contents or replace the product. 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. If you have any questions about this communication, please contact us at 781-538-6594.
Quantity in commerce: 445 units
Distribution: US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
Product codes and lots: UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1156-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1156-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-22

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)