medical Class II Updated 2019-10-09

Merit Medical Systems, Inc. recalls Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-036

Recalled Product

Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409


Hazard / Issue

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

Issued by

FDA

Affected States: VA, IL
Lot/Code Info: Catalog #K12T-03688H - Lot #T1401193 and #T1419935
View official government recall

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