Recall Z-0026-2020— Merit Medical Systems, Inc.

Name: FDA recall Z-0026-2020
Creator: U.S. Food and Drug Administration
Published: 2018-10-26

Class II · Terminated

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2018-10-26, terminated 2020-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409. Reason: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free).

Recalling firm: Merit Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-26
Terminated: 2020-06-12
Firm location: South Jordan, UT, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.