PlainRecalls
FDA Devices Moderate Class II Terminated

(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.

Reported: November 13, 2019 Initiated: October 16, 2018 #Z-0288-2020

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.

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?
(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.. 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-0288-2020.