FDA Device recall Z-2109-2020
Skater Introducer Set 6F x 18cm
- FDA Device
- Class II
- terminated
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Skater Introducer Set 6F x 18cm by Argon Medical Devices, citing tungsten coils of the guidewire included in the introducer kit were detaching.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2109-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-26 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Argon Medical Devices |
| Distribution | n/a |
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.
Reason
Tungsten coils of the guidewire included in the introducer kit were detaching.
Identifiers
| code_info | REF /LOT: 651506300/ 11267865, 11271397, 11277305, 11287825, 11293349, 11288772, 11290387, 11263199, 11262264, 11258778…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Argon Medical Devices
- L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
FDA Device · Class II · 2026-08-05 · Argon Medical Devices - General Biospy Tray, REF: GUTS1000
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - Arterial Line Kit 20ga x 6, REF: 400115A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices - One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
All Argon Medical Devices recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2109-2020%22
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