# FDA recall Z-2109-2020

> **Argon Medical Devices, Inc** · Class II · device recall initiated 2020-04-26.

## Product

Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.

## Reason for recall

Tungsten coils of the guidewire included in the introducer kit were detaching.

## Distribution

International distribution to the countries of China, Taiwan.

## Key facts

- **Recall number:** Z-2109-2020
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-26
- **Report date:** 2020-06-03
- **Termination date:** 2022-12-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2020

## Citation

> AI Analytics. FDA recall Z-2109-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2109-2020. Source: US FDA. Licensed CC0.

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