# FDA recall Z-2806-2020

> **Argon Medical Devices, Inc** · Class II · device recall initiated 2020-06-19.

## Product

ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifications. These products facilitate access to a vein or artery, allowing various catheters to be passed through for local or central diagnostic or therapeutic interventions. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

## Reason for recall

Sterile introducer sheath set manufactured under one lot with different expiration dates.

## Distribution

US Nationwide distribution including in the state of MS.

## Key facts

- **Recall number:** Z-2806-2020
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-19
- **Report date:** 2020-08-26
- **Termination date:** 2023-04-12

- **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-2806-2020

## Citation

> AI Analytics. FDA recall Z-2806-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2806-2020. Source: US FDA. Licensed CC0.

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