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.
Argon Medical Devices, Inc
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-0295-2020Don't want to check this manually?
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