Argon Medical Devices, Inc: Medical Device Recall in 2019 - (Recall #: Z-0288-2020)

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:

(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.

Product Classification:

Class II

Date Initiated: October 16, 2018

Date Posted: November 13, 2019

Recall Number: Z-0288-2020

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:

(1) Double Female LL Adapter-special adapter to convert male fitting to a female luer lock - Lot numbers 11228606, 11227966, 11226655; and (2) Double Male LL Adapter-special adapter to convert a female fitting to a male luer lock - Lot numbers 11227508, 11229885, 11230268, and 11231393.

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