Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2021-07-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2501-2021
Date of alert: 2021-07-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Argon Medical Devices, Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00886333225552

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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Recall 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.

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Recall 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.