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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 Model Number: 80004004

Z-1155-2023

December 22, 2022

Class II

Product summary

Firm
Access Vascular, Inc
Event
Event 91529
Status
Ongoing
Classification
Class II
Quantity
155 units
Official record key
device-enforcement:Z-1155-2023

Official wording

Reason: Product Mislabeled on the outer bag and inner kit Tyvek header bag

Code information: UDI: (01)00850030354020 Lot Number: 11434018

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeled