Device 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.

Z-2109-2020

April 26, 2020

Class II

Product summary

Firm: Argon Medical Devices, Inc
Event: Event 85562
Status: Terminated
Classification: Class II
Quantity: 15,795 units
Official record key: device-enforcement:Z-2109-2020

Official wording

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

Code information: 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

Distribution pattern: International distribution to the countries of China, Taiwan.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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