FDA recall Z-0026-2020

Merit Medical Systems, Inc. · Class II · device

Product

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)

Distribution

U.S.: VA, IL

Key facts

Status
Terminated
Initiation date
2018-10-26
Report date
2019-10-09
Termination date
2020-06-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0026-2020