Argon Medical Devices, Inc: Medical Device Recall in 2020 - (Recall #: Z-2109-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: April 26, 2020

Date Posted: June 3, 2020

Recall Number: Z-2109-2020

Event ID: 85562

Reason for Recall:

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

Status: Terminated

Product Quantity: 15,795 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated