# FDA recall Z-1956-2020

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2019-09-12.

## Product

Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.

## Reason for recall

labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging.  The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.

## Distribution

US Nationwide distribution in the state of MI.

## Key facts

- **Recall number:** Z-1956-2020
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-12
- **Report date:** 2020-05-20
- **Termination date:** 2022-05-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1956-2020

## Citation

> AI Analytics. FDA recall Z-1956-2020. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1956-2020. Source: US FDA. Licensed CC0.

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