Z-0026-2020 Class II Terminated
FDA device recall Z-0026-2020 was initiated by Merit Medical Systems, Inc. on Oct 26, 2018 and is designated Class II. Reason for recall: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free) The recall status is terminated (terminated Jun 12, 2020). Affected quantity: 88 Kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2019
- Initiation Date
- Oct 26, 2018
- Termination Date
- Jun 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 88 Kits
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)
Distribution Pattern
U.S.: VA, IL
Code Information
Catalog #K12T-03688H - Lot #T1401193 and #T1419935
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0026-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026