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.
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Access Vascular is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits because the outer bag and inner Tyvek header bag are mislabeled. This could cause users to select the wrong product for IV therapy, potentially leading to incorrect medical procedures.
The product is mislabeled on both the outer bag and inner Tyve: header bag. This could lead to using the wrong kit for intravenous therapy, which might cause incorrect medical procedures or complications.
Healthcare professionals using this kit for short-term IV access (<30 days) are most at risk. Patients receiving IV therapy with this kit could be affected if mislabeled.
Check for the product model number 80004004 on the outer bag. The kit was sold with lot number 11434018 and UDI (01)00850030354020.
Look for the model number 80004004 on the outer bag and UDI (01)00850030354020 to confirm it's the recalled kit.
The recall is due to mislabeling, not safety issues. The product is safe if used correctly but may be mislabeled.
The recall notice does not specify a remedy, so no action is required beyond checking the labels.
Check for model number 80004004 on the outer bag and lot number 11434018.
We’ve drafted a message you can send Access Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-1155-2023 — Access Vascular Access Vascular Hello, I own a Access Vascular that is covered by recall Z-1155-2023 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.
