Recall Z-2109-2020— Argon Medical Devices, Inc
Class II · Terminated
Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2020-04-26, terminated 2022-12-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Argon Medical Devices, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-26
- Terminated
- 2022-12-16
- Firm location
- Athens, TX, United States
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.
Reason for recall
Tungsten coils of the guidewire included in the introducer kit were detaching.
Data sourced from openFDA. This site is unofficial and independent of the FDA.