Argon Medical Devices, Inc: Medical Device Recall in 2019 - (Recall #: Z-0295-2020)

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 Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. 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-0295-2020

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 numbers 11228251 and 11229805

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