# FDA recall Z-0688-2018

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2017-12-14.

## Product

PreludeSNAP Splittable Hydrophilic and  non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5

## Reason for recall

Merit Medical Systems, Inc. is voluntarily conducting a recall of specific lots of Prelude  SNAP Splittable Sheath Introducers due to an intermittent failure of the splittable hub.

## Distribution

US, Australia, EU, Serbia, Israel, Malaysia, South Africa, Bahrain

## Key facts

- **Recall number:** Z-0688-2018
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-14
- **Report date:** 2018-02-28
- **Termination date:** 2020-07-10

- **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-0688-2018

## Citation

> AI Analytics. FDA recall Z-0688-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0688-2018. Source: US FDA. Licensed CC0.

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