medical Class II Updated 2020-06-03

Argon Medical Devices, Inc recalls Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)0088

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: International distribution to the countries of China, Taiwan.
Lot/Code Info: REF /LOT: 651506300/ 11267865, 11271397, 11277305, 11287825, 11293349, 11288772, 11290387, 11263199, 11262264, 11258778, 11254942, 11253443 REF/ LOT: 655506300 / 11268009, 11284776, 11266592, 11285976, 11287826, 11280359, 11260512, 11252843, 11248583, 11277295
View official government recall

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