FDAFDA · Food and drugs·Recall number Z-2501-2021
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.
Published September 29, 2021 · Recall initiated: July 8, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Argon Medical Devices, Inc
- Distributor
- U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
- Lot
- Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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