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Argon Medical Devices, Inc recalls Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250
Recalled November 13, 2019 · FDA recall Z-0294-2020 · Argon Medical Devices
Hazard
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. · FDA Class II
Units
Total number in recall for all products in dist: 49,130 units
Sold at
Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
Description
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Product
Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
Manufacturer(s)
Argon Medical Devices, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →