# FDA recall Z-2239-2021

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2021-06-30.

## Product

Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985.  For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.

## Reason for recall

There is a potential that 7F sheaths are packaged as 10F sheaths.

## Distribution

US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI    OUS: Norway

## Key facts

- **Recall number:** Z-2239-2021
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-30
- **Report date:** 2021-08-18
- **Termination date:** 2023-02-24

- **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-2239-2021

## Citation

> AI Analytics. FDA recall Z-2239-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2239-2021. Source: US FDA. Licensed CC0.

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