Argon Medical Devices, Inc: Medical Device Recall in 2019 - (Recall #: Z-0294-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Product Classification:

Class II

Date Initiated: October 16, 2018

Date Posted: November 13, 2019

Recall Number: Z-0294-2020

Event ID: 83633

Reason for Recall:

The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Status: Terminated

Product Quantity: Total number in recall for all products in dist: 49,130 units

Code Information:

Lot number 11232311

Distribution Pattern:

Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated