FDA-Device2023-03-01Class II
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
Access Vascular, Inc
Hazard
Product Mislabeled on the outer bag and inner kit Tyvek header bag
Sold states
US Nationwide distribution in the states of FL, TX, WA.
Affected count
155 units
Manufactured in
749 Middlesex Tpke, N/A, Billerica, MA, United States
Products
HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1155-2023Don't want to check this manually?
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