Medical device recalls Moderate risk

Access Vascular, Inc recalls HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

Recall date
December 16, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1129-2023
FDA classification
Class II
Brand / firm
Access Vascular, Inc
Sold / distributed
US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.

Why it was recalled

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002

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