Argon Medical Devices, Inc recalls Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medic…
- Recall date
- October 16, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0295-2020
- FDA classification
- Class II
- Brand / firm
- Argon Medical Devices, Inc
- Sold / distributed
- Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Why it was recalled
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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