FDAFDA · Food and drugs·Recall number Z-0291-2020
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.
Published November 13, 2019 · Recall initiated: October 16, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Argon Medical Devices, Inc
- Distributor
- Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
- Lot
- Lot number 11226919
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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