FDA recall Z-0288-2020

Argon Medical Devices, Inc · Class II · device

Product

(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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-10-16
Report date
2019-11-13
Termination date
2021-06-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2020