FDA-Device2019-11-13Class II
Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Hazard
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Sold states
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Affected count
Total number in recall for all products in dist: 49,130 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0295-2020More Argon Medical Devices, Inc recalls
- FDA-Device2026-07-22Argon Medical Devices General Biopsy Tray recalled for sterility concerns
- FDA-Device2026-07-22Argon Medical Devices Arterial Line Kit recalled for sterility test failure
- FDA-Device2026-07-22Argon Medical Devices pacing electrode trays recalled for sterility failure in lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices One-Piece Introducer Tray recalled for sterility failure in Lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices T-Lok Bone Marrow Tray recalled for sterility failure
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