HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the...
FDA Recall #Z-1155-2023 — 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 Model Number: 80004004
Reason for Recall
Product Mislabeled on the outer bag and 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
155 units
Distribution
US Nationwide distribution in the states of FL, TX, WA.
Code Information
UDI: (01)00850030354020 Lot Number: 11434018
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated