Z-0288-2020 Class II Terminated
FDA device recall Z-0288-2020 was initiated by Argon Medical Devices, Inc on Oct 16, 2018 and is designated Class II. 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. The recall status is terminated (terminated Jun 15, 2021). Affected quantity: Total number in recall for all products in dist: 49,130 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 13, 2019
- Initiation Date
- Oct 16, 2018
- Termination Date
- Jun 15, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total number in recall for all products in dist: 49,130 units
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.
Distribution Pattern
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0288-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026