Reported Mar 1, 2023 · Ongoing
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous…
Access Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Access Vascular, Inc · 749 Middlesex Tpke · Billerica, MA · 01821-3906
Is this the product you have?
- HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous
- therapy Product Model Number80004004
- Lot codes and dates
- UDI(01)00850030354020
- Lot Number11434018
- Amount recalled
- 155 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Product Mislabeled on the outer bag and inner kit Tyvek header bag
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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