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Recall Observatory FDA recall evidence

Device product

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

Z-1156-2023

December 22, 2022

Class II

Product summary

Firm
Access Vascular, Inc
Event
Event 91533
Status
Ongoing
Classification
Class II
Quantity
445 units
Official record key
device-enforcement:Z-1156-2023

Official wording

Reason: Label with the incorrect component listed on the inner kit Tyvek header bag

Code information: UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076

Distribution pattern: US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Label with the incorrect