Lower riskMedical device recall · FDA · Published December 22, 2022
Access Vascular HydroMID 4Fr Kit Mislabeled - Risk of Wrong Product Use
Access Vascular recalls HydroMID 4Fr Single Lumen Maximal Barrier Kit due to mislabeling on outer and inner bags. This may lead to incorrect product use in IV therapy. No remedy specified in recall notice.
“Access Vascular HydroMID 4Fr Kit Mislabeled - Risk of Wrong Product Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59058-access-vascular-hydromid-4fr-kit-mislabeled-risk-of-wrong-product. Based on FDA recall #Z-1155-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1155-2023%22&limit=1).
Access Vascular, Inc. voluntarily recalled HydroMID 4Fr Single Lumen Maximal Barrier Kits on Dec. 22, 2022, because the product was mislabeled on the outer bag and inner kit Tyvek header bag, according to the FDA.
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
Model Number: 80004004
UPC: 00850030354020
Lot Number: 11434018
Units affected: 155
The hazard
The recalled HydroMID 4Fr Single Lumen Maximal Barrier Kits were mislabeled on the outer bag and inner kit Tyvek header bag. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Access Vascular, Inc. has issued five other recalls since Feb. 24, 2021. Other recent recalls of similar products include Windstone Custom Convenience Kits Pre Op Kit Recall (March 11, 2026) and Arrow MAC Two-Lumen Central Venous Access Kit Recall (March 11, 2026).
How to tell if you have this one
Check for the product model number 80004004 on the outer bag. The kit was sold with lot number 11434018 and UDI (01)00850030354020.
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 Labels
Look for the model number 80004004 on the outer bag and UDI (01)00850030354020 to confirm it's the recalled kit.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, TX, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, 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-1155-2023 (December 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1155-2023 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.