Merit Medical Systems, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0027-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 26, 2018

Date Posted: October 9, 2019

Recall Number: Z-0027-2020

Event ID: 83738

Reason for Recall:

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

Status: Terminated

Product Quantity: 24 kits

Code Information:

Catalog # K12T-10167, Lot # K12T-10167, Use By: 2018-11-05

Distribution Pattern:

U.S.: VA, IL

Voluntary or Mandated:

Voluntary: Firm initiated