FDA-Device2021-09-29Class II
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Argon Medical Devices, Inc
Hazard
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Sold states
U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Affected count
20 units
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2501-2021Don't want to check this manually?
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