(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.
Enforcement
- Recall Number
- Z-0288-2020
- Event ID
- 83633
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Argon Medical Devices, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 13, 2019
- Initiation Date
- October 16, 2018
- Classification Date
- November 5, 2019
- Termination Date
- June 15, 2021
- Address
- 1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States
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.
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
(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 was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Total number in recall for all products in dist: 49,130 units