Argon Medical Devices, Inc: Medical Device Recall in 2020 - (Recall #: Z-2806-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 19, 2020

Date Posted: August 26, 2020

Recall Number: Z-2806-2020

Event ID: 86036

Reason for Recall:

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

Status: Terminated

Product Quantity: 1000 units

Code Information:

LOT 11295042

Distribution Pattern:

US Nationwide distribution including in the state of MS.

Voluntary or Mandated:

Voluntary: Firm initiated