PlainRecalls
FDA Devices Moderate Class II Terminated

Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

Reported: November 13, 2019 Initiated: October 16, 2018 #Z-0289-2020

Product Description

Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.

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.

Details

Units Affected
Total number in recall for all products in dist: 49,130 units
Distribution
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Location
Athens, TX

Frequently Asked Questions

What product was recalled?
Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.. Recalled by Argon Medical Devices, Inc. Units affected: Total number in recall for all products in dist: 49,130 units.
Why was this product recalled?
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0289-2020.