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.
Reported: June 3, 2020 Initiated: April 26, 2020 #Z-2109-2020
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.
Details
- Recalling Firm
- Argon Medical Devices, Inc
- Units Affected
- 15,795 units
- Distribution
- International distribution to the countries of China, Taiwan.
- Location
- Athens, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Argon Medical Devices, Inc. Units affected: 15,795 units.
Why was this product recalled? ▼
Tungsten coils of the guidewire included in the introducer kit were detaching.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2020. Severity: Moderate. Recall number: Z-2109-2020.
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