Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF Recalled by Argon Medical Devices, Inc Due to The incorrect sheath was assembled to the device...

Date: February 17, 2016
Company: Argon Medical Devices, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Argon Medical Devices, Inc directly.

Affected Products

ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Quantity: 2000 units

Why Was This Recalled?

The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.

Where Was This Sold?

This product was distributed to 1 state: IL

Affected (1 state)Not affected

About Argon Medical Devices, Inc

Argon Medical Devices, Inc has 42 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report