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

Recall Z-2109-2020 — Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-

U.S. FDA — Device Enforcement · United States · 2020-04-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2109-2020
Date of alert: 2020-04-26
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): 651506300

Reported risk: Tungsten coils of the guidewire included in the introducer kit were detaching.

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

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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