Reported Sep 29, 2021 · Ongoing
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture…
Argon Medical Devices, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002
Is this the product you have?
- Scorpion
- Portal Vein Access Set - Product Usageused to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma
- Lot codes and dates
- Item Numbers
TPS005 (Stylet)TPS006 (Needle)
- UDI Code00886333225552
- Lot Number11369609
- Item Numbers
- Amount recalled
- 20 units
Where it was sold
- Nationwide
- WA
Why it was recalled
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
This product could cause temporary or reversible health problems — stop using it.
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