HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the ...
FDA Recall #Z-1156-2023 — Class II — December 22, 2022
Product Description
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
Reason for Recall
Label with the incorrect component listed on the inner kit Tyvek header bag
Recalling Firm
Access Vascular, Inc — Billerica, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
445 units
Distribution
US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
Code Information
UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated