Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000 Recalled by Argon Medical Devices, Inc Due to Tungsten coils of the guidewire included in the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Argon Medical Devices, Inc directly.
Affected Products
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-vascular procedures.
Quantity: 15,795 units
Why Was This Recalled?
Tungsten coils of the guidewire included in the introducer kit were detaching.
Where Was This Sold?
International distribution to the countries of China, Taiwan.
About Argon Medical Devices, Inc
Argon Medical Devices, Inc has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report