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.
Label with the incorrect component listed on the inner kit Tyvek header bag
Access Vascular is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits for short-term IV access. The recall is due to an incorrect label on the inner Tyvek bag, which could cause confusion during use.
The inner Tyvek bag has an incorrect label, which could lead to confusion about the components during IV therapy. This might cause errors in the setup or use of the kit if healthcare providers misidentify parts.
Healthcare professionals using the HydroMID kit for short-term IV therapy are likely affected. Patients receiving IV treatment with this kit may be at risk if the label confusion leads to incorrect use.
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).
Verify the product number (80004004) and lot numbers (11424032, 11432076) on the kit.
The recall is due to a label issue, not a safety hazard. The kit is safe for short-term IV use if the label is correctly identified.
The official recall notice does not specify a remedy, so check with Access Vascular for further instructions.
Look for product number 80004004 and lot numbers 11424032 or 11432076 on the HydroMID 4Fr Single Lumen Maximal Barrier Kit.
We’ve drafted a message you can send Access Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1156-2023 — Access Vascular Access Vascular Hello, I own a Access Vascular that is covered by recall Z-1156-2023 from Access Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
