Medical device recalls Moderate risk

Merit Medical Systems, Inc. recalls Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

Recall date
October 26, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0027-2020
FDA classification
Class II
Brand / firm
Merit Medical Systems, Inc.
Sold / distributed
U.S.: VA, IL

Why it was recalled

Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)

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

What was recalled

Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

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