Lower riskMedical device recall · FDA · Published December 22, 2022
Access Vascular HydroMID 4Fr Kit: Incorrect Label on Inner Bag
Access Vascular recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit for incorrect label on inner Tyvek bag. This may cause confusion during IV therapy. Check product details to see if affected.
“Access Vascular HydroMID 4Fr Kit: Incorrect Label on Inner Bag.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59067-access-vascular-hydromid-4fr-kit-incorrect-label-on-inner-bag. Based on FDA recall #Z-1156-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1156-2023%22&limit=1).
The FDA announced on 2022-12-22 that Access Vascular, Inc voluntarily recalled HydroMID 4Fr Single Lumen Maximal Barrier Kits due to labeling errors. The inner kit Tyvek header bag lists an incorrect component. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Access Vascular
Product: HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access
UPC: 00850030354020
Lot Numbers: 11424032, 11432076
The hazard
The recall involves the HydroMID 4Fr Single Lumen Maximal Barrier Kit where the label on the inner kit Tyvek header bag lists an incorrect component. The FDA stated this labeling error constitutes a Class II recall hazard.
Context
GovInfoNow's records show Access Vascular, Inc has issued five other recalls since 2021-02-24. Recent brand recalls include the HydroPICC Kit with incorrect instructions on 2023-08-31 and the HydroPICC Catheter with a shorter expiration date risk on 2023-03-03. Other recent recalls of similar products include Medline IV Kits Recall (2025-11-26), Windstone Custom Convenience Kits Pre Op Kit Recall (2026-03-11), and Medline TRACH TUBE KIT Recall (2026-07-10).
How to tell if you have this one
Check for the product number 80004004 and lot numbers 11424032 or 11432076 on the HydroMID 4Fr Single Lumen Maximal Barrier Kit. The kit is intended for short-term IV access (<30 days).
Brand
Access Vascular
Product
HydroMID 4Fr Single Lumen Maximal Barrier Kit
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product number (80004004) and lot numbers (11424032, 11432076) on the kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Connecticut, Florida, Nebraska, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1156-2023 (December 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1156-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.