# FDA recall Z-3191-2024

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2024-08-12.

## Product

Custom Procedure Kit, REF: K12T-11077

## Reason for recall

7F sheath introducers labeled as 7.5F

## Distribution

Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.

## Key facts

- **Recall number:** Z-3191-2024
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-12
- **Report date:** 2024-10-02

- **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-3191-2024

## Citation

> AI Analytics. FDA recall Z-3191-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-3191-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*