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Argon Medical Devices, Inc recalls Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: Th
Recalled June 3, 2020 · FDA recall Z-2109-2020 · Argon Medical Devices
Hazard
Tungsten coils of the guidewire included in the introducer kit were detaching. · FDA Class II
Units
15,795 units
Sold at
International distribution to the countries of China, Taiwan.
Description
Tungsten coils of the guidewire included in the introducer kit were detaching.
Product
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.
Manufacturer(s)
Argon Medical Devices, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →