FDAClass IIMarch 1, 2023

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated recall

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy…

Why was HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy…
Recalling firm
Access Vascular, Inc
Quantity
445 units
Distribution
US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
Recall date
March 1, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls