Agency classClass IIOur severity:High FDA (Devices)·Z-1156-2023·Announced 2023-03-01

HydroMID 4Fr Peripheral Venous Catheter Kit Recalled for Incorrect Component Labeling

Access Vascular is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits due to an incorrect component listed on the inner kit label. The error could lead to confusion and improper use of the device.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a labeling error on a medical device used for patient IV therapy. Although no illnesses or injuries have been reported, the incorrect component information presents a risk of harm if providers use or assemble the device improperly. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Access Vascular, Inc. is recalling HydroMID 4Fr Single Lumen Maximal Barrier Kits (Product Number 80004004) used for short-term peripheral venous access for intravenous therapy. The recall was initiated because the inner kit Tyvek header bag contains incorrect component information.

This labeling error could lead healthcare providers to use or assemble the device incorrectly, potentially compromising patient safety. The device is intended for short-term IV access (less than 30 days).

Approximately 445 units were distributed nationwide to medical facilities in Connecticut, Florida, Nebraska, Tennessee, Texas, and Washington. Affected lot numbers are 11424032 and 11432076 (UDI-DI: 00850030354020).

Healthcare providers who have received these kits should discontinue use and contact Access Vascular, Inc. for replacement units or further instructions.

The recalled product

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
Manufacturer: Access Vascular, Inc
Category: Medical Device — Vascular Access / IV Catheter
Hazard: mis-labeling
Affected units: 445

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Access Vascular, Inc

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Same hazard · mis labeling