# FDA recall Z-2243-2021

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2021-07-21.

## Product

MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391

## Reason for recall

There is a potential that a package sheath contains an incorrect dilator.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of ID, HI, TX, CA, AZ, MN, UT, KS, MO and the countries of Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, and Spain.

## Key facts

- **Recall number:** Z-2243-2021
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-21
- **Report date:** 2021-08-18
- **Termination date:** 2023-03-13

- **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-2243-2021

## Citation

> AI Analytics. FDA recall Z-2243-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2243-2021. Source: US FDA. Licensed CC0.

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