Z-0291-2020 Class II Terminated
FDA device recall Z-0291-2020 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
Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label 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
Lot number 11226919
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0291-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026