Class II — Argon Medical Devices, Inc
| Recalling firm | ARGON MEDICAL DEVICES, INC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Tungsten coils of the guidewire included in the introducer kit were detaching. |
| 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. |
| Quantity | 15,795 units |
| Distribution | International distribution to the countries of China, Taiwan. |
| Initiated | 2020-04-26 |
| Classified | 2020-05-22 |
| Terminated | 2022-12-16 |
| Recall number | Z-2109-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Argon Medical Devices, Inc (Z-2109-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85562/
Alerts for ARGON MEDICAL DEVICES, INC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.