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.
Reported: September 29, 2021 Initiated: July 8, 2021 #Z-2501-2021
Product Description
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.
Reason for Recall
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Details
- Recalling Firm
- Argon Medical Devices, Inc
- Units Affected
- 20 units
- Distribution
- U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
- Location
- Athens, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Argon Medical Devices, Inc. Units affected: 20 units.
Why was this product recalled? ▼
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2501-2021.
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