FDAClass IISeptember 29, 2021

Scorpion Portal Vein Access Set - Product Usage: used recall

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…

Why was Scorpion Portal Vein Access Set - Product Usage: used recalled?

As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609

Product
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…
Recalling firm
Argon Medical Devices, Inc
Quantity
20 units
Distribution
U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Recall date
September 29, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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