FDA-Device2020-06-03Class II
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.
Hazard
Tungsten coils of the guidewire included in the introducer kit were detaching.
Sold states
International distribution to the countries of China, Taiwan.
Affected count
15,795 units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2109-2020More Argon Medical Devices, Inc recalls
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